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<?xml version="1.0" encoding="UTF-8"?><rss version="2.0" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:wfw="http://wellformedweb.org/CommentAPI/" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:atom="http://www.w3.org/2005/Atom" xmlns:sy="http://purl.org/rss/1.0/modules/syndication/" xmlns:slash="http://purl.org/rss/1.0/modules/slash/" > <channel> <title>Vial</title> <atom:link href="https://vial.com/feed/" rel="self" type="application/rss+xml" /> <link>https://vial.com/</link> <description></description> <lastBuildDate>Mon, 24 Jun 2024 21:25:20 +0000</lastBuildDate> <language>en-US</language> <sy:updatePeriod> hourly </sy:updatePeriod> <sy:updateFrequency> 1 </sy:updateFrequency> <generator>https://wordpress.org/?v=6.7.1</generator> <image> <url>https://vial.com/wp-content/uploads/2024/07/cropped-Group-47950-1-32x32.png</url> <title>Vial</title> <link>https://vial.com/</link> <width>32</width> <height>32</height></image> <item> <title>Predictive Analytics in Clinical Trials</title> <link>https://vial.com/blog/articles/predictive-analytics-in-clinical-trials/</link> <comments>https://vial.com/blog/articles/predictive-analytics-in-clinical-trials/#respond</comments> <dc:creator><![CDATA[Owen Allen]]></dc:creator> <pubDate>Mon, 24 Jun 2024 21:25:20 +0000</pubDate> <category><![CDATA[Articles]]></category> <category><![CDATA[clinical trials]]></category> <category><![CDATA[CRO]]></category> <category><![CDATA[CRO's]]></category> <category><![CDATA[CROs]]></category> <guid isPermaLink="false">https://vial.com/?p=49054</guid> <description><![CDATA[The fields of artificial intelligence (AI) and machine learning (ML) are increasingly influencing clinical research and development (R&D). Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery. This article explores the numerous benefits that AI and ML offer in clinical R&D settings, […]]]></description> <content:encoded><![CDATA[<p>The fields of artificial intelligence (AI) and machine learning (ML) are increasingly influencing clinical research and development (R&D). <a href="https://vial.com/blog/articles/what-is-a-cro/?https://vial.com/events/first-in-human-the-panel-series-on-navigating-the-ophthalmology-clinical-operations-landscape-insights-for-advancement/">Contract research organizations (CROs)</a> and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery. This article explores the numerous benefits that AI and ML offer in clinical R&D settings, focusing on how predictive analytics can bring precision and efficiency to the forefront of trial design and execution.</p> <h2 class="wp-block-heading"><strong>Clinical Trial Data Management</strong></h2> <p>The clinical trial process is inherently complex and multifaceted, involving a series of rigorously controlled stages, each demanding meticulous planning and execution. One of the most arduous aspects within this framework is managing the large volume of data that must be collected, analyzed, and interpreted. As clinical trials grow in complexity, the volume of data being gathered and utilized for these studies is expanding. In addition to the myriad of data points collected for new clinical research, an abundance of historical data available from previously conducted trials remains underutilized. Predictive analytics provides the tools needed to tap into this vast reservoir of data and convert it into actionable insights, enabling more precise decision-making and driving advancements in clinical research.</p> <h3 class="wp-block-heading">Traditional CDMS and Digital Integration</h3> <p>Historically, clinical trials relied on conventional paper-based methods of clinical data management, which can be time-consuming and result in frequent errors. The introduction of digital clinical data management systems (CDMS), such as electronic data capture (<a href="https://vial.com/edc/?https://vial.com/events/first-in-human-the-panel-series-on-navigating-the-ophthalmology-clinical-operations-landscape-insights-for-advancement/">EDC</a>), electronic patient-reported outcomes (<a href="https://vial.com/epro/?https://vial.com/events/first-in-human-the-panel-series-on-navigating-the-ophthalmology-clinical-operations-landscape-insights-for-advancement/">ePRO</a>), and electronic case report forms (eCRF), has significantly enhanced operational efficiency, improved accessibility to real-world data (RWD), and broadened participant recruitment. Additionally, remote data entry opens new avenues for global collaboration and more inclusive, data-driven clinical research. This digital transformation has not only streamlined the data management process but also enabled real-time data analysis and increased clinical trials’ overall quality and reliability.</p> <h3 class="wp-block-heading">How Machine Learning Improves CDMS</h3> <p>Traditional data analysis methods in clinical trials is complex and labor-intensive due to the predominantly manual processes where statisticians and data analysts must sift through multiple datasets to identify trends, clean data, and validate endpoints. The sheer volume and complexity of real-world and clinical data involved in clinical R&D necessitate implementing advanced, sophisticated, and innovative data strategies.</p> <h2 class="wp-block-heading">What is Predictive Analytics?</h2> <p>Predictive analytics uses various statistical algorithms to process large, complex datasets using RWD to forecast potential outcomes. These technologies can process data with efficiency beyond human capabilities. By identifying patterns and trends within the data, predictive analytics can accurately project likely future scenarios and provide strategic recommendations to optimize clinical trial planning and execution. This technology optimizes several processes within clinical trials, such as:</p> <h3 class="wp-block-heading">1. Enhanced Patient Selection and Recruitment</h3> <p>Predictive technologies analyze datasets from demographic and health registries, electronic health records (EHRs), genomic records, and clinical trial databases to enhance patient selection and recruitment in clinical trials. This approach allows researchers to identify individuals who best fit the trial criteria based on genetic markers, health history, and demographic information. As a result, trials become more targeted and efficient, with higher participant retention rates and a greater likelihood of recruiting patients who will benefit from and respond to the treatment.</p> <h3 class="wp-block-heading">2. Risk Assessment and Management</h3> <p>Predictive analytics plays a crucial role in risk assessment and management. It analyzes historical data to form predictions of potential risks and adverse events, allowing preemptive measures to be taken. This proactive approach enhances patient safety, reduces the likelihood of trial interruptions, and ensures more reliable results, leading to safer and more effective treatments.</p> <h3 class="wp-block-heading">3. Trial Design Strategy</h3> <p>Predictive technology contributes to improved recruitment rates, minimizes the occurrence of non-enrolling sites, and further reduces the frequency of protocol modifications by identifying trial sites that provide a high probability of success. Utilizing predictive ML technology in study designs lessens the time required for protocol development, and reduces the need for protocol amendments, thereby increasing overall study efficiency.</p> <h3 class="wp-block-heading">4. Data Quality</h3> <p>One of the significant challenges in clinical trials is maintaining data quality and integrity. Predictive analytics helps to identify inconsistencies and errors, promoting higher accuracy and reliability. It also supports real-time decision-making, which is crucial for the dynamic nature of clinical trials.</p> <h3 class="wp-block-heading">5. Forecasting Drug Efficacy and Safety</h3> <p>Advanced statistical methods and machine learning algorithms create predictive models using data from previous trial records and other relevant data points. ML algorithms process large quantities of data from multiple sources, further refining the accuracy of predictions. By analyzing this information, these models equip researchers with critical insights into potential side effects, drug interactions, and overall drug efficacy.</p> <h3 class="wp-block-heading">6. Personalizing Treatments</h3> <p>ML algorithms can analyze extensive medical records to detect patterns and characteristics, such as genetic markers or disease progression trends, to identify specific patient subgroups that may respond differently to treatments. This targeted approach enables the development of more personalized therapeutic strategies. These algorithms can also analyze demographic and geographic data from social media and other public data platforms, leading to more relevant clinical trials.</p> <h2 class="wp-block-heading">Challenges in Implementing Predictive Analytics</h2> <p>Predictive analytics offers the potential to optimize clinical trials in many ways. However, harnessing the full potential of ML and AI technologies requires effectively navigating several key challenges.</p> <h3 class="wp-block-heading">Inconsistencies in Standards and Data Structures</h3> <p>The variability of data structures and standards across and within organizations presents a significant challenge. To address these complexities, organizations can adopt universally accepted data standards, such as that set by CDISC (Clinical Data Interchange Standards Consortium), which provide a consistent framework for data collection, exchange, and reporting.</p> <h3 class="wp-block-heading">Lack of Accessibility and Interoperability</h3> <p>A large portion of clinical data is unavailable or difficult to access for AI applications. Despite ongoing efforts to unify data entry, multiple healthcare IT standards continue to pose challenges in health data interoperability. This diversity in standards complicates the integration of patient information across medical organizations using different EHR software systems. While the lack of interoperability challenges AI’s effectiveness, there are solutions that could bridge these gaps. Natural Language Processing (NLP) models can extract clinical data from various heterogeneous sources, including symptoms and diagnoses. These models can then consolidate this information into trial databases, offering an alternative solution to standardizing health records and other varied data sources.</p> <h3 class="wp-block-heading">Data Privacy and Security</h3> <p>Data privacy and security are also significant concerns with the use of AI and ML predictive models in clinical data management and assessment. Privacy regulations like HIPAA mandate stringent data security measures. Still, consolidating EHRs and other sensitive data into large databases for analytics increases the risk of data breaches. Such breaches compromise patient privacy and expose companies to substantial costs and legal penalties.</p> <p>Clinical trial databases could adopt robust security frameworks, such as zero-trust architecture and continuous automated monitoring, to mitigate data breach risks and compromise. Additionally, scrubbing datasets of personally identifiable information (PII) before analysis can help safeguard patient privacy. By implementing these advanced security measures and consistently adhering to privacy regulations, the use of predictive analytics in healthcare can be made safer and more ethically sound, ensuring the protection of individual privacy.</p> <h3 class="wp-block-heading">A Lack of Expertise</h3> <p>The rapid advancement of ML and AI technologies has outpaced the availability of adequately trained personnel who can apply these sophisticated processes in the context of clinical trials. ML and AI algorithms are inherently complex and require a deep understanding of both the technology and the specific application domain. The lack of technicians with this expertise can lead to challenges in effectively implementing and leveraging these tools within clinical trials.With targeted efforts in education, training, and collaboration, the clinical trial industry can overcome this challenge and continue to advance in its use of these innovative technologies.</p> <h2 class="wp-block-heading">Looking Ahead</h2> <p>Looking ahead, the prospects of predictive analytics in clinical trials are promising. As technological advancements continue, we can expect more sophisticated solutions to emerge, further enhancing the effectiveness of predictive analytics. Future developments will likely focus on refining AI algorithms for greater accuracy, expanding interoperability solutions, and strengthening data security frameworks. The ongoing evolution in predictive analytics promises to transform clinical trials into more efficient, effective, and patient-centric endeavors. This progression will benefit clinical R&D and contribute significantly to advancing personalized medicine, ultimately improving patient outcomes and care.</p> <h3 class="wp-block-heading">Vial CRO: Elevating Clinical Research</h3> <p><a href="https://vial.com/?https://vial.com/events/first-in-human-the-panel-series-on-navigating-the-ophthalmology-clinical-operations-landscape-insights-for-advancement/">Vial is a full-service contract research organization (CRO) </a>delivering faster, more efficient trials at dramatically lower costs for biotech sponsors around the globe. Our tech-forward approach is centered around a seamlessly connected technology platform, an experienced team of ClinOps professionals, and a transparent fixed-fee pricing model that ensures cost-effectiveness.</p> <p>Vial CRO’s modern, intuitive technology platform integrates trial onboarding, patient enrollment, site communication, and data collection processes into one connected system. With Vial CRO, you can trust in a partner dedicated to bridging the gap between cutting-edge science and the practicality of clinical trials, all while keeping affordability and efficiency at the forefront.</p> <p>Connect with a team member to learn more or request a demo of our technology!</p>]]></content:encoded> <wfw:commentRss>https://vial.com/blog/articles/predictive-analytics-in-clinical-trials/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Improving Diversity: Increased Patient Access to Clinical Trials</title> <link>https://vial.com/blog/articles/improving-diversity-increased-patient-access-to-clinical-trials/</link> <comments>https://vial.com/blog/articles/improving-diversity-increased-patient-access-to-clinical-trials/#respond</comments> <dc:creator><![CDATA[Owen Allen]]></dc:creator> <pubDate>Tue, 18 Jun 2024 21:04:47 +0000</pubDate> <category><![CDATA[Articles]]></category> <category><![CDATA[clinical trials]]></category> <category><![CDATA[CRO]]></category> <category><![CDATA[CRO's]]></category> <category><![CDATA[CROs]]></category> <guid isPermaLink="false">https://vial.com/?p=49041</guid> <description><![CDATA[The success of clinical trials hinges on increasing access to participation by all eligible patients, including populations that have been underrepresented due to the barriers highlighted below. Researchers understand the importance of diversity in clinical trials, and to ensure or increase it, they must evaluate each study and its unique characteristics to uncover the barriers […]]]></description> <content:encoded><![CDATA[<p>The success of clinical trials hinges on increasing access to participation by all eligible patients, including populations that have been underrepresented due to the barriers highlighted below. Researchers understand the importance of diversity in clinical trials, and to ensure or increase it, they must evaluate each study and its unique characteristics to uncover the barriers and facilitators of participation. We examine the patient perspective, share examples of underrepresentation and potential solutions, and present how digital health technologies have been applied to increase accessibility in clinical trials.</p> <h2 class="wp-block-heading">Representation, Underrepresentation & Diversity in Clinical Trials</h2> <p>Studies indicate a need to increase patient accessibility to clinical trials. Lack of representation in clinical trials, e.g., a lack of racial and ethnic diversity, leads to suboptimal patient recruitment, skewed findings, limitations in the generalizability of study results to a broader population, inequitable health outcomes, and suboptimal development of innovative therapies for all. In addition to causing research waste, the lack of access to clinical trials by patients hampers the speed with which needed therapies are developed and brought to market. Recognizing the issue of underrepresentation of racial and ethnic minorities in clinical trials, e.g., for Alzheimer’s Disease (AD), researchers have sought to understand the barriers and facilitators for patient access better.</p> <p>Although AD disproportionately affects U.S. Black/African American and Hispanic/Latino adults in terms of prevalence, incidence, and outcomes, these populations are underrepresented in AD clinical research. Specifically, U.S. Hispanic/Latino individuals are at increased risk for AD and related dementias (AD/ADRD), experience higher disease burden, and receive low levels of care and services but are underrepresented.</p> <p>A recent study examined gender-based differences in willingness to participate in clinical trials and found that the influence of gender on participation may be moderated by other factors, e.g., socioeconomic status, ethnicity, and health condition. The authors concluded that evaluating each study and its unique characteristics and considering factors that influence willingness to participate, which are specific to a study cohort, will help optimize participant recruitment.</p> <h2 class="wp-block-heading">Patient Perspective & Potential Solutions</h2> <p>A qualitative study on the patient’s perspective was conducted to identify the potential barriers and facilitators of study participation and preferred modes of delivery for education and information. Across different races and ethnicities, barriers included</p> <p>limited awareness of clinical trial opportunities, concerns about the impact on standard therapy, issues with cultural norms and stigma, and mistrust of clinical research. Patients underlined the need for transparency by pharma and other related companies to build trust and partnership. The response of the African American group appeared to diverge from others, citing a lack of trust in providers, concerns about past instances of research abuse, and the importance of prayer. The researchers suggest that sponsors and other entities authentically engage in efforts to build trust within communities to enhance engagement and recruitment of diverse populations.</p> <p>Additionally, a recent survey of trial staff and community members revealed that the former identified logistics and patients’ unwillingness to receive additional treatment as barriers to participation. On the other hand, community members identified a lack of information and trust in their care team as barriers. Both groups agreed that reluctance toward research is a prominent barrier.</p> <h2 class="wp-block-heading">Barriers & Facilitators by Indication</h2> <p>Equity in care requires concerted and deliberate efforts that ensure underrepresented populations in indications such as AD, cancer, inflammatory bowel disease (IBD), and multiple sclerosis (MS), amongst others, participate fully in and benefit from clinical research.</p> <h3 class="wp-block-heading">Alzheimer’s Disease (AD)</h3> <p>To develop an effective digital intervention to increase research participation of Black/African American participants in the brain health registry, researchers found that a culturally-informed Community-Engaged Research approach, including a remotely-convened community board to engage participants, is feasible and can be adapted for various clinical studies.</p> <p>Separately, a study called for the remedying of structural barriers to Hispanic/Latino representation in AD/ADRD trials. They highlighted that past efforts typically focused on individual- and family-level aspects, e.g., language, cultural beliefs, knowledge of aging and memory loss, and limited awareness of research, neglecting upstream institutional- and policy-level barriers. The authors assert that structural barriers that need attention include misalignments in research budgets, study protocols, workforce competencies, criteria for reviewing and approving trial funding, and social determinants of health (SDoH).</p> <h3 class="wp-block-heading">Cancer</h3> <p>Commaroto <em>et al.</em> evaluated racial and ethnic differences in knowledge, attitudes, and invitations to participate in clinical trials among U.S. cancer survivors. Across all populations, they found the strong influence of physician recommendation—the most trusted source of information and the first point of contact patients would go to seek clinical trial information. In addition, the desire to improve one’s health is the strongest motivator, and the majority of respondents expressed their willingness to participate if it benefited others.</p> <p>The researchers also found prevailing disparities in clinical trial knowledge, with non-Hispanic White participants having higher levels of awareness and a mismatch between provider and patient knowledge (and attitudes) toward trial participation. Further, the education level of patients is positively correlated with awareness of clinical trials. The authors stress the need to understand patient personal motivators, the value of diversifying clinical trial information platforms to enhance engagement with different racial and ethnic groups, and the fact that efforts to improve clinical trial enrollment should incorporate patient values into clinical decision-making. Also, they found it essential to equip healthcare providers with the knowledge and communication skills to discuss clinical trial options with their patients effectively.</p> <h3 class="wp-block-heading">Inflammatory Bowel Disease (IBD)</h3> <p>Patient recruitment challenges for IBD trials include study design, competitive or overlapping trials, and a lack of eligible patients. Rubin <em>et al.</em> identified opportunities to improve IBD trial participation, including improved communication with healthcare providers, patient education, and trial designs. As with other indications, a better understanding of the patient perspective is critical for successful recruitment and enrollment.</p> <h3 class="wp-block-heading">Multiple Sclerosis (MS)</h3> <p>To address the mismatch in demographic characteristics, SDoH, health inequities, and health disparities observed between participants in clinical trials and people with MS treated in practice, Marrie <em>et al.</em> held an international workshop to develop recommendations regarding diversity and inclusivity of participants of clinical trials. These included using diversity plans, community engagement and education, cultural competency training, biologically justified rather than templated eligibility criteria, adaptive designs, and adjustments to reduce participant burden. The recommendations further advise investigators to report patient demographics and SDoH characteristics.</p> <h3 class="wp-block-heading">Musculoskeletal Disorders (MSD)</h3> <p>To identify strategies to increase recruitment of visible minorities in MSD research, Le <em>et al.</em> first identified barriers to participation, which include mistrust, logistical obstacles, and lack of awareness or understanding of research. The researchers recommended collaborating with communities of visible minorities, recruiting through sites serving the community of interest, and addressing logistical barriers to begin reducing barriers to participation.</p> <h2 class="wp-block-heading">How do patients enroll in clinical trials?</h2> <h3 class="wp-block-heading">Digital health technologies (DHTs)</h3> <p>The rapidly evolving field of digital health technologies (DHTs) enables the radical transformation of clinical trials and a shift from site-centric to patient-centric clinical research. Clinical trials need not be bound by geographical constraints, and DHTs can enhance access to clinical trials to represent the SDoH across populations.</p> <h3 class="wp-block-heading">Decentralized clinical trials (DCTs)</h3> <p>With decentralized clinical trials (DCTs), patients in rural areas or with low socioeconomic status can enroll in clinical trials remotely. <a href="https://vial.com/blog/articles/what-are-decentralized-clinical-trials">DCTs make clinical trials more accessible</a> for participants because they require fewer recruitment steps than traditional clinical trials, improve participant engagement and retention, and increase the diversity of the participant population by reaching geographically remote patients.</p> <p>A recent study on willingness to participate in cancer clinical trials during the pandemic found that patients viewed trial modifications such as virtual platforms, local assessments, and greater flexibility favorably and supported the continuation of National Cancer Institute (NCI)- endorsed modifications.</p> <h3 class="wp-block-heading">Artificial Intelligence (AI)</h3> <p>Artificial intelligence (AI) is already being used to accelerate clinical trials in multiple ways, including patient recruitment and engagement. A bioinformatician from Columbia University, Chunhua Weng, has developed tools to help patients seeking trials to participate. One system first extracts criteria from trial descriptions and then generates relevant questions for potential participants to help narrow down their searches. Weng anticipates that this approach may reduce the issue of trials unnecessarily excluding populations, e.g., children, the elderly, or pregnant patients. Efforts have also been made to apply AI in improving patient retention, e.g., using past data to predict participants most likely to drop out, allowing timely interventions, or powering chatbots to answer patient questions.</p> <h2 class="wp-block-heading">Vial – Reimagining Clinical Trials</h2> <p>The success of clinical trials hinges on increasing access to all eligible patients, including populations that have been underrepresented for the reasons described above. For sponsors, <a href="https://vial.com/blog/articles/how-patient-centricity-helps-with-clinical-trial-retention">both recruitment and retention represent challenges</a>. <a href="https://www.biopharmadive.com/spons/decentralized-clinical-trials-are-we-ready-to-make-the-leap/546591/">Eighty-five percent</a> of clinical trials fall short of their recruitment objectives, while 80 percent experience delays relating to recruitment struggles, including high dropout rates. Patient access, engagement, recruitment, and retention in clinical trials improve significantly by using a patient-centric approach.</p> <p>Vial is a tech-first CRO delivering faster, better, and more affordable clinical trial results for biotech sponsors. Our modern, intuitive technology platform integrates trial onboarding, patient enrollment, site communication, and data collection into one connected system. Vial is building a more efficient future for clinical trials.</p> <p><a href="https://vial.com/contact-us/">Let’s connect!</a> Talk to a Vial team member today.</p>]]></content:encoded> <wfw:commentRss>https://vial.com/blog/articles/improving-diversity-increased-patient-access-to-clinical-trials/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Importance of Patient-Reported Outcomes in Clinical Trials</title> <link>https://vial.com/blog/articles/importance-of-patient-reported-outcomes-in-clinical-trials/</link> <comments>https://vial.com/blog/articles/importance-of-patient-reported-outcomes-in-clinical-trials/#respond</comments> <dc:creator><![CDATA[Owen Allen]]></dc:creator> <pubDate>Thu, 13 Jun 2024 05:22:00 +0000</pubDate> <category><![CDATA[Articles]]></category> <category><![CDATA[clinical trials]]></category> <category><![CDATA[CRO]]></category> <category><![CDATA[CRO’s]]></category> <category><![CDATA[CROs]]></category> <category><![CDATA[patient-reported outcome measures]]></category> <category><![CDATA[patient-reported outcomes]]></category> <category><![CDATA[PRO]]></category> <category><![CDATA[PROM]]></category> <guid isPermaLink="false">https://vial.com/?p=49031</guid> <description><![CDATA[Introduction Patient-reported outcomes (PROs) refer to information about a patient’s health that is shared directly by the patient and not influenced by the interpretation of any other. Utilizing PROs enables the active participation of patients in their care outcomes – both in a clinical setting and in clinical research. PROs in clinical trials are important […]]]></description> <content:encoded><![CDATA[<h2 class="wp-block-heading">Introduction</h2> <p>Patient-reported outcomes (PROs) refer to information about a patient’s health that is shared directly by the patient and not influenced by the interpretation of any other. Utilizing PROs enables the active participation of patients in their care outcomes – both in a clinical setting and in <a href="https://vial.com/glossary/clinical-research">clinical research</a>. PROs in <a href="https://vial.com/glossary/clinical-trial">clinical trials</a> are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated. From a regulatory standpoint, agencies like the U.S. <a href="https://vial.com/glossary/food-and-drug-administration-fda">Food and Drug Administration</a> (FDA) increasingly look to patients to understand how they describe their health status.</p> <h2 class="wp-block-heading">What are PROs in clinical trials?</h2> <p>The National Cancer Institute (<a href="https://vial.com/glossary/national-cancer-institute-nci">NCI</a>) defines patient-reported outcomes as a patient’s description of their symptoms and satisfaction with care or how a condition or intervention affects their physical, mental, emotional, spiritual, and social well-being. In clinical trials, PROs may assess disease progression, consequence(s) of the intervention being studied, functional status, and social, mental, and emotional limitations. These aspects influence a patient’s perceived health-related quality of life (QoL). PROs, included in clinical trials as primary or secondary <a href="https://vial.com/glossary/endpoint">endpoints</a>, are increasingly recognized by regulators, clinicians, and patients as valuable tools.</p> <p>While PROs may not have unconditional acceptance and wide use in clinical research across all therapeutic areas, they have been in use for over a decade in some. PROs are gaining a more prominent role in clinical research for <a href="https://vial.com/glossary/cancer">cancer</a> and conditions like multiple myeloma, but the use of PROs is in its exploratory phase. Tech advancements and digital health tools make clinical research more accessible with <a href="https://vial.com/glossary/epro-electronic-patient-reported-outcome">electronic PRO</a> (ePRO) options.</p> <h2 class="wp-block-heading">How and What to measure?</h2> <p>PROs can be disease-specific, condition-specific, or generic. As the names imply, disease-specific PROs measure features specific to a disease or syndrome, while condition-specific PROs describe aspects of a particular condition, intervention, or treatment not uniquely associated with one disease. A recent study found that approximately 20 disease-specific PROs have been used in <a href="https://vial.com/glossary/heart-failure-hf">heart failure</a> (HF) patients for research and clinical purposes. However, they have been used inconsistently. Generic PROs are used for any disease or population.</p> <p>For HF, Savarese <em>et al.</em> found substantial disagreement between patient-reported information using the Kansas City Cardiomyopathy Questionnaire (KCCQ), which the FDA qualified as a clinical outcomes assessment, and physician-assigned clinical status defined by the New York Heart Association functional class, indicating an information gap that needs to be addressed.</p> <h2 class="wp-block-heading">Why have PROs been more common recently?</h2> <p>PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated. Further, PROs have demonstrated precision in evaluating disease status and a good association with prognosis in randomized controlled trials (RCTs) for conditions like HF.</p> <p>Including PROs in clinical research has been more common as PROs measured with high-quality PRO measures (PROMs) help evaluate treatment effects, identify unmet needs, and define meaningful outcomes for patients. In addition, regulatory agencies like the FDA published PRO guidelines for industry as early as 2006 and increasingly encourage using PROs in trials. Additionally, PROs bring value to clinical research in several ways including:</p> <h3 class="wp-block-heading">Assessing complex conditions</h3> <p>Complex conditions like HF and multiple myeloma impact mortality, morbidity, and different levels of a patient’s life, impairing various aspects of daily living. Moving away from the situation where physicians assessed disease status and symptom severity solely, PROs provide valuable insights into a patient’s disease experience. As medical staff assessment of patient symptom severity is often lower than PRO for multiple myeloma, Wang et al. suggest enriching the content of PROs and developing more high-quality PRO scales for multiple myeloma.</p> <h3 class="wp-block-heading">Converting disease-specific PROs to support cost-effectiveness analyses</h3> <p>When direct calculation of health utility is not possible, mapping algorithms are available to convert disease-specific PROs to EuroQol 5 Dimension (EQ-5D) to estimate QoL and then conduct cost-effectiveness analyses.</p> <h3 class="wp-block-heading">Non-disease-specific PROs provide more complete info</h3> <p>Especially for patients with multiple chronic diseases, non-disease-specific PROs might be useful for assessing interventions that might improve a symptom but simultaneously cause major complications. Such complications may otherwise be missed if only disease-specific PROs are used.</p> <h3 class="wp-block-heading">Mismatch between outcome definitions and patient experience</h3> <p>In cases where there is effective treatment, such as for tuberculosis (TB), but there exists a mismatch between conventional outcome definitions and a patient’s lived experience, PROs offer valuable insights into non-observable elements like health literacy and overall well-being, which contribute to the comprehensive evaluation of research end-points.</p> <h2 class="wp-block-heading">Facilitating the Inclusion of PROs in clinical trials</h2> <h3 class="wp-block-heading">Standardization</h3> <p>As PROMs on health-related QoL are often designated secondary outcomes in trials, data collection and reporting may not be standardized, resulting in difficulty making comparisons and interpretations. In a study on cancer clinical trials, Pe <em>et al.</em> cautioned that having multiple ways of analyzing and interpreting PRO data could lead to flawed and inconsistent decisions by patients and medical staff alike and negatively affect patient outcomes. The authors present international stakeholder views on the need for standardization by building on existing PRO guidelines to establish recommendations on the design, analysis, presentation, and interpretation of PRO data in clinical trials.</p> <h3 class="wp-block-heading">Adherence to guidelines</h3> <p>A study by Newman <em>et al.</em> evaluated the quality of PRO reporting for RCTs studying pregnant women with diabetes. Evaluated against the internationally accepted guidelines Consolidated Standards of Reporting Trials (CONSORT-PRO), the researchers found that only 17% of RCTs included a PRO as a primary or secondary outcome. The median score was 46 (out of 100), indicating gaps in reporting. They emphasize the importance of including reliable PROs in trials. A study investigating the use of PROs in clinical trials of palliative radiotherapy found poor to moderate adherence to CONSORT-PRO. Further, studies on cystic fibrosis (CF), carpal tunnel syndrome (CTS), and multiple sclerosis (MS), conditions that can affect QoL substantially, found inadequate PRO reporting, prompting authors of all three studies to recommend greater adherence to CONSORT-PRO.</p> <h3 class="wp-block-heading">Change vs. baseline</h3> <p>As indicated by Di Maio, many cancer drugs have recently received regulatory approval based on single-<a href="https://vial.com/glossary/arm">arm</a> studies. In these studies, QoL and PROs simply describe changes vs. <a href="https://vial.com/glossary/baseline">baseline</a> and trends over time, which can ultimately introduce bias. The authors recommend avoiding methodologically weak evidence and involving PRO experts in the planning, executing, and interpreting of findings.</p> <h3 class="wp-block-heading">Electronic PRO (ePRO)</h3> <p>Early research suggests that racial and ethnic minority groups, older patients, and patients with lower levels of education attainment may benefit even more from ePRO options. <a href="https://vial.com/glossary/cro-contract-research-organization">Contract research organizations</a> (CROs) like <a href="https://vial.com/">Vial</a> provide digital health tools such as ePRO, which are compliant and customizable for the convenience of trial participants.</p> <h2 class="wp-block-heading">How does the FDA weigh the benefits of positive PROs?</h2> <p>The FDA’s first publication of the draft guidance for PROs for industry came out almost 20 years ago. The FDA increasingly looks to patients to understand how they describe their health status. Clinical outcome assessments (COAs) may capture outcomes important to patients, and PROs, as defined by the FDA, are one form of COA. By researching, developing, and refining COA measures, the FDA actively strengthens its ability to use patient-focused methodology to inform decision-making. To improve how it assesses the benefit of positive PROs in HF, for example, the FDA works with academia to explore how previously developed PRO instruments may be modified to capture outcomes of diverse patient groups adequately.</p> <h3 class="wp-block-heading">Use of PRO assessments</h3> <p>Specifically for <a href="https://vial.com/glossary/oncology">oncology</a> drugs, Moore et al. evaluated all <a href="https://vial.com/glossary/new-drug-application-nda">new drug applications</a> (NDAs) submitted to the FDA from 2013 – 2022 that were approved through the accelerated approval process to assess whether those trials included PROs. They found that 59% of such trials included PRO assessments; however, PRO measurements were inconsistently utilized.</p> <h3 class="wp-block-heading">Role of PROs in drug approvals</h3> <p>A recent review sought to comprehensively characterize the inclusion of PROs and regulatory considerations in FDA-approved novel oncology drugs. The researchers analyzed FDA review documents and labels for novel oncology drugs from 2017 to 2022, including types of endpoints for PROs, PRO measures, designs of trials including PROs, and regulatory comments on PRO-related contents. They found that PROs currently do not play a significant role in oncology drug approvals and concluded that the use of PROs to support oncology drug approval is still in the exploratory stage. These findings are related to the deficiencies in the design and execution of PRO-related content in cancer clinical trial.</p> <h2 class="wp-block-heading">Vial – Reimagining Clinical Trials</h2> <p>Vial is a tech-first CRO that delivers faster, better, and more affordable clinical trial results for biotech sponsors. Vial CRO’s modern, intuitive technology platform integrates trial onboarding, patient enrollment, site communication, and data collection into one connected system for efficiency.</p> <p>The <a href="https://vial.com/epro">Vial ePRO</a> offers a seamless, user-friendly interface that is accessible by mobile or desktop. Interactive functions, built-in data validation, and skip logic provide quick, intuitive, compliant data capture. A connected data flow between Vial ePRO and <a href="https://vial.com/edc">Vial EDC</a> enables effortless, accurate, and real-time data recording and storage. <a href="https://vial.com/contact-us">Connect with a team member</a> today!</p>]]></content:encoded> <wfw:commentRss>https://vial.com/blog/articles/importance-of-patient-reported-outcomes-in-clinical-trials/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Medable vs. Vial | Pros and Cons</title> <link>https://vial.com/blog/articles/medable-vs-vial-pros-and-cons/</link> <comments>https://vial.com/blog/articles/medable-vs-vial-pros-and-cons/#respond</comments> <dc:creator><![CDATA[Owen Allen]]></dc:creator> <pubDate>Tue, 28 May 2024 20:35:28 +0000</pubDate> <category><![CDATA[Articles]]></category> <category><![CDATA[#clinicaltrial]]></category> <category><![CDATA[#clinicaltrials]]></category> <category><![CDATA[CRO]]></category> <category><![CDATA[CRO's]]></category> <category><![CDATA[CROs]]></category> <guid isPermaLink="false">https://vial.com/?p=48991</guid> <description><![CDATA[In the rapidly expanding world of digital health, Medable and Vial CRO (Contract Research Organization), two leading technology organizations, are revolutionizing the way clinical research is conducted. Founded in 2016 and 2020 respectively, both companies are making significant strides to offer efficient, digital solutions within the pharmaceutical industry, each offering their own unique suite of […]]]></description> <content:encoded><![CDATA[<p>In the rapidly expanding world of digital health, Medable and Vial <a href="https://vial.com/glossary/cro-contract-research-organization/">CRO (Contract Research Organization)</a>, two leading technology organizations, are revolutionizing the way <a href="https://vial.com/glossary/clinical-research/">clinical research</a> is conducted. Founded in 2016 and 2020 respectively, both companies are making significant strides to offer efficient, digital solutions within the pharmaceutical industry, each offering their own unique suite of tools and products to facilitate patient-centric <a href="https://vial.com/glossary/clinical-trial/">clinical trials</a>. Although both have missions driving them to steer the clinical research industry away from outdated, paper-based <a href="https://vial.com/glossary/data-management/">data management</a> systems, each differs in their operation approaches, therapeutic focus, and the specific features of their technology platforms. In this article, we will delve into these differences between Vial and Medable, as well as their similarities, while providing a comprehensive overview to help determine which best fits your clinical research needs.</p> <p><strong>Overview of Medable (Palo Alto, California)</strong></p> <p>Founded in 2016, Medable is a leading technology organization that provides an end-to-end, global cloud platform that offers sponsors and CROs a flexible suite of tools that enables more efficient clinical research. The company was established by Dr. Michelle Longmire, who was inspired by her own struggle to reach patients in her research on rare skin diseases. Experiencing first-hand how clinical research has been constrained by obsolete processes and technologies for the past two decades, Dr. Longmire rallied stakeholders, partners, and developers to establish Medable. Medable was created based on a shared vision to dramatically increase the number of effective therapies available to patients each year. Since then, Medable has become a leading technology provider for patient-centric clinical trials, particularly decentralized clinical trials.</p> <p>A commitment to enhancing the quality, reach, speed, and cost-effectiveness of research is the cornerstone of Medable’s approach. The company also prioritizes the personal experiences of patients and caregivers, working in close collaboration with their network of sites to continuously improve its clinical trial technology platform. The Medable platform is a user-friendly tool that combines <a href="https://vial.com/glossary/econsent/">eConsent (electronic Consent)</a> and <a href="https://vial.com/glossary/ecoa/">eCOA (electronic clinical outcome assessment)</a> technology to offer an all-in-one integrated solution for participants, sites, and sponsors. Medable’s significant contributions to the field of clinical research is underscored by their several accolades, including ranking in the top 8% of the 2023 Inc. 5000 list of America’s fastest-growing private companies, as well as being recognized as the ‘Best Digital Health Solution’ at the Prix Galien USA Forum.</p> <p><strong>Overview of Vial CRO (San Francisco, California)</strong></p> <p>Established in 2020, Vial is a new yet promising player in the global CRO market headquartered in San Francisco, California. With its tech-oriented approach, the company’s mission drives Vial’s growing team of clinical professionals to yield faster, superior, and more cost-effective results for biotech sponsors. This tech-first CRO was also established to promote the use of modern technology platforms within the pharmaceutical industry and bring the world of clinical trials out of the paper stone age. Recognizing this gap of inefficiency plaguing clinical research for decades, Vial’s in-house team of software engineering experts developed a cloud-native, end-to-end system for streamlined processes. The Vial platform contains the capacity for tools such as <a href="https://vial.com/glossary/edc/">EDC (electronic data capture)</a>, <a href="https://vial.com/glossary/epro-electronic-patient-reported-outcome/">ePRO (electronic patient-reported outcomes)</a>, <a href="https://vial.com/glossary/electronic-source/">eSource (electronic source)</a>, as well as a Site Startup Portal. As a result, the company’s accessible and user-friendly solutions have made it an efficient and cost-effective partner, traits highly sought after by sponsors. Already in use throughout sites across the United States, Vial’s cutting-edge technology platform brings together all trial aspects, from onboarding to data collection, into a unified, modern system.</p> <p>Among their several notable achievements, Vial successfully raised $67 million in 2022 in a Series B round led by General Catalyst, in addition to gaining support from entities like Byers Capital and BoxGroup. Vial also partnered with NEXT <a href="https://vial.com/glossary/oncology/">Oncology</a>, a global network of <a href="https://vial.com/glossary/phase-i/">phase I</a> <a href="https://vial.com/glossary/cancer/">cancer</a> research clinics based in San Antonio, Texas that provide treatments for patients with advanced cancers. Most recently in 2023, Vial entered into a strategic alliance with Mason America Inc., who will supply Vial with hardware for clinical sites, facilitating secure and remote device management for eSource on a significantly larger scale. This further demonstrates Vial’s commitment to replace traditional, inefficient paper-based methods with digital solutions that promote inclusivity, affordability, and innovation.</p> <p><strong>Medable eCOA+ and Total Consent</strong></p> <p>The Medable platform is composed of two core components: eCOA+ and Total Consent. eCOA is an innovative tool that uses electronic devices to collect data from trial participants. With over 300 pre-built and validated instruments available, Medable eCOA+ ensures an industry-standardized, consistent method of data collection, which drives real-time decision making. It also supports a BYOD (Bring Your Own Device) model, which enables patients to use familiar devices for data capture, leading to better compliance and improved clinical trial experience.</p> <p>Total Consent is another powerful tool in Medable’s platform, functioning as a complete consent management solution. It is an eConsent tool designed to consent trial participants electronically, either in-clinic or remotely, using various web-enabled devices . Total Consent is designed with global compliance in mind, meeting all global regulations including the <a href="https://vial.com/glossary/food-and-drug-administration-fda/">Food and Drug Administration’s</a> <a href="https://vial.com/glossary/21-cfr-part-11-2/?utm_source=organic">21 CFR Part 11</a>, ICH E6 (R2), and GDPR. Unlike many other eConsent platforms, Medable provides a robust solution for collection of compliant signatures, whether digital or wet-ink, on-site or remote. The tool also supports over 115 languages, making it deployable worldwide in any country conducting clinical research.</p> <p><strong>Vial EDC, ePRO, and eSource</strong></p> <p>Vial’s flagship product is an in-house custom <a href="https://vial.com/edc/?">EDC platform</a> that simplifies the process of study startup and build, reduces reliance on vendors, and accommodates flexible data integration. The tool provides a user-friendly interface that has been implemented in over 30 clinical research sites and in use by more than 1500 participants across the US. It also strictly adheres to regulatory guidelines such as the FDA’s 21 CFR Part 11, <a href="https://vial.com/glossary/health-insurance-portability-and-accountability-act-hipaa-privacy-rule/">HIPAA</a> (Health Insurance Portability and Accountability Act), and GDPR.</p> <p>The second component of the Vial suite of technology is <a href="https://vial.com/epro/">Vial ePRO</a>, which boasts a seamless, user-friendly interface easily accessible by mobile or desktop, in addition to built-in data validation, skip logic, and interactive functions for swift and compliant data capture. The Vial ePRO module also facilitates real-time patient monitoring and enhanced reporting, as well as precise, real-time data recording and storage through its interconnected data flow with Vial EDC.</p> <p>The final component, <a href="http://(https://vial.com/esource/?)">Vial eSource</a>, replaces paper-based data capture for sites, integrating with Vial EDC to eliminate double data entry, increase data entry quality, and promote centralized remote monitoring. Its interface is driven by standardized data types, data validation, range rules on entry, required fields, and skip logic, among other features. This tool from Vial offers real-time data capture and is constructed on CDISC standards with SDTM-controlled terminology for quality on entry.</p> <p><strong>Comparing Medable vs. Vial: Which Best Fits Your Needs?</strong></p> <p><em>Technology Platform</em></p> <p>Both Medable and Vial platforms offer comprehensive solutions for clinical trials, with a focus on streamlining processes, promoting patient engagement, and ensuring regulatory compliance. For example, each offers its own tool to enable seamless collection of patient data during their participation. However, although Medable’s eCOA+ and Vial ePRO are both compliant with industry standards, the latter provides an additional advantage of being integrated into an existing EDC system within the same platform that reduces the need for double data entry from investigative sites. Vial’s eSource, a tool not currently offered by Medable, also creates a user-friendly experience for <a href="https://vial.com/glossary/clinical-research-or-study-coordinator-crc/">clinical research coordinators</a>, ensuring greater efficiency with data management at the site level. However, unlike Vial’s suite, Medable’s use of Total Consent means sponsors can further simplify their patient enrolment process by utilizing the included consent management system.</p> <p><em>Therapeutic Focus</em></p> <p>Another point of difference between Medable and Vial are their areas of therapeutic focus. Medable’s solutions are currently tailored to meet the needs for indications within oncology and vaccine research. In contrast, Vial has dedicated teams of experts and <a href="https://vial.com/glossary/clinops-clinical-operations/">ClinOps (Clinical Operations)</a> professionals for each of their nine specialty CROs: <a href="https://vial.com/cro/oncology/">Oncology</a>, <a href="https://vial.com/cro/dermatology/">Dermatology</a>, <a href="https://vial.com/cro/ophthalmology/">Ophthalmology</a>, <a href="https://vial.com/cro/gastroenterology/">Gastroenterology</a>, <a href="https://vial.com/cro/neurology/">CNS (Central Nervous System)</a>, <a href="https://vial.com/cro/cardiology/">Cardiology</a>, <a href="https://vial.com/cro/medical-device/">Medical Device</a>, <a href="https://vial.com/cro/rare-disease/">Rare Disease</a>, and <a href="https://vial.com/cro/digital-therapeutics/">Digital Therapeutics</a>. Therefore, whereas Medable is better suited for a new vaccine clinical trial, sponsors interested in a full-service CRO across various therapeutic areas may find Vial a more convenient fit. As for oncology, the deciding factor would depend on the client’s technological needs for their study and how it can be addressed either by Medable’s or Vial’s digital platform.</p> <p><em>Operation Approach</em></p> <p>While both Medable and Vial are committed to improving healthcare delivery, their approaches do differ somewhat. Medable comparatively operates with a more patient-centric approach in their products. Their eCOA+ and Total Consent tools are tailored to enhance patient access, experience, and outcomes, reflecting their commitment to putting patients at the heart of their operations. Vial, however, adopts a solid data-driven approach with a fully integrated suite of tools which significantly improve efficiency and quality for sponsors, CROs, and research sites. Although Vial ePRO certainly provides ease of use for trial participants, the crosstalk between the platforms is especially valuable for remote data management.</p> <p><strong>Conclusion</strong></p> <p>Both Medable and Vial CRO provide several innovative solutions for conducting clinical trials in today’s digital age. Medable, with its patient-centric approach, focuses on enhancing patient access and experience, particularly excelling in oncology and vaccine research. Vial, on the other hand, offers a robust, data-driven platform, with a comprehensive suite of tools that streamline processes across various therapeutic areas. The choice between Medable and Vial ultimately depends on the specific needs and priorities of clinical trial sponsors, whether it be a patient-centric approach, specific therapeutic focus, or a fully integrated trial management platform.</p> <p><strong>Vial: The CRO for Biotech, Powered by Technology</strong></p> <p><em>Our mission at <a href="https://vial.com/cro">Vial</a> as a next-generation, tech-first CRO is to empower scientists to discover groundbreaking scientific therapeutics that help people live happier, healthier lives. <a href="https://vial.com/contact-us/">Contact a Vial representative today</a> to discover how we can make a difference for your next clinical trial!</em></p>]]></content:encoded> <wfw:commentRss>https://vial.com/blog/articles/medable-vs-vial-pros-and-cons/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Veeva vs Vial | Pros and Cons</title> <link>https://vial.com/blog/articles/veeva-vs-vial-pros-and-cons/</link> <comments>https://vial.com/blog/articles/veeva-vs-vial-pros-and-cons/#respond</comments> <dc:creator><![CDATA[Owen Allen]]></dc:creator> <pubDate>Wed, 22 May 2024 17:23:06 +0000</pubDate> <category><![CDATA[Articles]]></category> <category><![CDATA[clinical trials]]></category> <category><![CDATA[CRO]]></category> <category><![CDATA[CRO's]]></category> <category><![CDATA[CROs]]></category> <guid isPermaLink="false">https://vial.com/?p=48970</guid> <description><![CDATA[Introduction Veeva Systems and Vial CRO (contract research organization) represent stakeholders in the clinical research landscape, which play integral roles in the successful execution of clinical trials. While the value each stakeholder, e.g., sponsor, study participants, sites, laboratories, solution providers, and regulatory authorities, brings to the table differs, the safe and ethical conduct of clinical […]]]></description> <content:encoded><![CDATA[<h2 class="wp-block-heading">Introduction</h2> <p>Veeva Systems and Vial CRO (<a href="https://vial.com/glossary/cro-contract-research-organization">contract research organization</a>) represent stakeholders in the <a href="https://vial.com/glossary/clinical-research/">clinical research</a> landscape, which play integral roles in the successful execution of <a href="https://vial.com/glossary/clinical-trial">clinical trials</a>. While the value each stakeholder, e.g., sponsor, study participants, sites, laboratories, solution providers, and regulatory authorities, brings to the table differs, the safe and ethical conduct of clinical trials requires the collaborative effort of all parties working in unison. From the point of view of pharmaceutical, biotech, and medical device sponsors of clinical research, we explore the benefits or drawbacks of the services and solutions offered by Veeva and Vial. We describe the contributions of Veeva and Vial to clinical research, highlighting where they share similarities and where they are distinctly different.</p> <h2 class="wp-block-heading">Introducing the Companies</h2> <h3 class="wp-block-heading">Overview of Vial CRO</h3> <p>Founded in 2020, Vial is a next-generation, tech-first CRO delivering faster, more efficient trials at dramatically lower costs for biotech sponsors. The Vial’s mission is to empower scientists to discover ground-breaking scientific therapeutics that help people live happier, healthier lives. Vial is more than just a CRO; the innovators, engineers, and <a href="https://vial.com/glossary/clinops-clinical-operations">ClinOps</a> (clinical operations) leaders have worked together to build a global, full-service CRO powered by intuitive end-to-end technology.</p> <p>The Vial Technology Platform is a scalable clinical trial infrastructure with a site start-up portal, digital visit capture capabilities, a study analytics dashboard, and end-to-end process automation. The modern, intuitive technology platform integrates trial onboarding, patient <a href="https://vial.com/glossary/enrollment">enrollment</a>, site communication, and data collection into one connected system. It includes <a href="https://vial.com/edc">EDC</a> (<a href="https://vial.com/glossary/edc/">electronic data capture</a>), <a href="https://vial.com/esource/">eSource</a> (<a href="https://vial.com/glossary/electronic-source/">electronic Source</a>), <a href="https://vial.com/epro">ePRO</a> (<a href="https://vial.com/glossary/epro-electronic-patient-reported-outcome/">electronic Patient-Reporting Outcome</a>), and eTMF (<a href="https://vial.com/glossary/etmf/">electronic Trial Master File</a>) provided by partner Egnyte.</p> <h3 class="wp-block-heading">Overview of Veeva Systems</h3> <p>Veeva Systems Inc. is a global provider of industry-specific, cloud-based software solutions focused on the global life sciences industry. The company has rapidly scaled from its launch in 2007, exceeding expectations year after year. Veeva Systems’s solutions are designed to meet the unique needs of its customers, from research and development (R&D) to commercialization. Veeva enables life sciences companies to benefit from modern cloud-based architectures and mobile applications without compromising industry-specific functionality or regulatory compliance. Veeva has customers ranging from the world’s largest pharmaceutical companies to emerging biotechs, contract sales organizations, and CROs.</p> <p>Co-founder and CEO Peter Gassner leads Veeva with a unique purpose and instills the “Veeva Way,” a set of values that prioritizes doing the right thing, customer success, employee success, and speed. In 2021, Gassner transformed Veeva into a public benefit corporation (PBC).</p> <h3 class="wp-block-heading">How Veeva differs from Vial</h3> <p>While Veeva and Vial bring vital competencies to clinical research and the running of clinical trials, their experience and expertise differ. One commonality is the desire to bring technological advances to healthcare, and bring life sciences companies into the digital age of <a href="https://vial.com/glossary/data-management">data management</a>. From the point of view of clinical research sponsors, we explore the benefits or drawbacks of the services and solutions offered by Veeva and Vial.</p> <h3 class="wp-block-heading">Veeva vs. Vial: CRO Services</h3> <p>Building on decades of experience in managing clinical trials, the people of Vial have come up close and personal with the pain points of past inefficiencies. Committed to always learning and improving, the curiosity of the Vial team propels it to keep building, finding new challenges, and fulfilling its vision of reimagining clinical trials. In addition, Vial’s experienced CRO executive team works closely with its expert site operations team to continuously review execution strategies, closely monitor patient recruitment efforts, and mitigate key study risks. Collectively, the insights and lessons learned enable informed planning and strategy development, including planning for technology needs. Small CROs like Vial are poised to <a href="https://vial.com/blog/articles/the-benefits-of-working-with-a-small-cro-speed-agility-and-working-with-a-true-partner">adopt the latest tech, identify opportunities for application, and provide insights</a> on how the tech may be deployed to improve clinical trial performance. Sponsors can enjoy a seamless solution of next-gen tech-first CRO services and enabling technologies from Vial.</p> <p>What Veeva may lack in CRO experience and expertise, it partners with its CRO clients who have adopted Veeva clinical data management solutions in their service offerings. Through the Veeva CRO Partner Program for Clinical Data Management, Veeva connects interested sponsors with their CRO partners who can build and deliver clinical studies for them.</p> <h3 class="wp-block-heading">Veeva vs. Vial: Technology platforms</h3> <p>The Vial Technology Platform leverages connected systems and intuitive design to run global clinical trials efficiently at scale, and the Veeva Vault Platform enables clinical data flow by connecting patients, sites, and researchers. Both Veeva and Vial share similar goals and convictions regarding the benefits of a single, connected technology platform enabling, e.g., streamlined processes within one end-to-end system. Sponsors enjoy more value faster with the Vial Technology Platform and Veeva Vault Platform. A pro for Veeva might be the possibility of sponsors integrating their Veeva Vault Platform with other Veeva tools and systems; functions and capabilities beyond the scope of clinical trials but for which the sponsors intend to use.</p> <h3 class="wp-block-heading">Veeva vs. Vial: Beyond tech connectivity</h3> <p>The Vial CRO team comprises experts in ClinOps and software product and engineering. Not only has the team worked together to develop Vial’s technology platform that delivers dramatically faster and more efficient trials for sponsors, but each member brings a wealth of experience and established relationships with different stakeholders in the clinical trial landscape. Vial CRO’s highly experienced project managers (PMs) and <a href="https://vial.com/glossary/cra-clinical-research-associates">clinical research associates</a> (CRAs) have therapeutic area experience and longstanding working relationships with sites, <a href="https://vial.com/glossary/pi-principal-investigator-or-primary-investigator">principal investigators</a> (PIs), scientists, and <a href="https://vial.com/glossary/clinical-research-or-study-coordinator-crc">clinical research coordinators</a> (CRCs), which facilitate the successful completion of clinical trials.</p> <h3 class="wp-block-heading">Veeva vs. Vial: Evolving needs and requirements</h3> <p>As a global, full-service CRO, Vial has hands-on exposure to and in-depth knowledge of the evolving clinical trial management industry’s rapidly changing needs and requirements. For example, understanding regulatory peculiarities in each country a clinical trial is conducted in and other unique challenges enables the Vial team to plan accordingly and, at the same time, leverage opportunities to enhance clinical trial performance. On a related point, knowledge of the evolving needs and requirements of clinical trials facilitates introducing and implementing new technology (see below!).</p> <h3 class="wp-block-heading">Veeva vs. Vial: Implementation of new systems</h3> <p>The implementation of new tech and systems may be hampered by various factors, including end-users’ lack of readiness to fully utilize the new system, which may affect data input and quality and clinical management decision-making. Other issues may arise from user resistance to change, data security, integration with existing systems, and regulatory compliance. Having been end-users themselves, the Vial team is well positioned to anticipate and address such issues in an effective manner.</p> <h3 class="wp-block-heading">Conclusion</h3> <p>Vial CRO and Veeva Systems are tech-first solution providers in the clinical trial landscape. However, Vial is also an experienced global full-service CRO. Sponsors can, therefore, enjoy a seamless solution of next-generation tech-first CRO services and enabling technologies from Vial. Further, small CROs like Vial are adept at understanding the unique clinical trial needs of sponsors and identifying opportunities for deploying the right technologies to drive efficiencies in speed and cost savings. As Veeva designs and develops tech solutions beyond the needs of clinical trial management, clients requiring such features and functions will benefit from integrating Veeva’s other innovative solutions.</p> <h2 class="wp-block-heading">Vial: The CRO for Biotech, Powered by Technology</h2> <p>Vial CRO is committed to reimagining clinical trials to deliver faster, more efficient trial results at dramatically lower costs for sponsors. By deploying technology at every step, we are driving efficiencies for innovative pharmaceutical and biotech companies of all sizes. To learn more about Vial CRO, <a href="https://vial.com/contact-us/?https://vial.com/blog/articles/what-is-interactive-response-technology-or-irt-in-clinical-trials">contact us today!</a></p>]]></content:encoded> <wfw:commentRss>https://vial.com/blog/articles/veeva-vs-vial-pros-and-cons/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research</title> <link>https://vial.com/blog/articles/distinguishing-the-roles-of-preclinical-vs-clinical-cros-in-clinical-research/</link> <comments>https://vial.com/blog/articles/distinguishing-the-roles-of-preclinical-vs-clinical-cros-in-clinical-research/#respond</comments> <dc:creator><![CDATA[Owen Allen]]></dc:creator> <pubDate>Mon, 20 May 2024 16:55:03 +0000</pubDate> <category><![CDATA[Articles]]></category> <category><![CDATA[Clinical Trial]]></category> <category><![CDATA[clinical trials]]></category> <category><![CDATA[CRO]]></category> <category><![CDATA[CRO's]]></category> <category><![CDATA[CROs]]></category> <guid isPermaLink="false">https://vial.com/?p=48945</guid> <description><![CDATA[Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. In the field of clinical research, this pipeline can be broken down into several stages and processes specifically designed to rigorously validate the safety and […]]]></description> <content:encoded><![CDATA[<p><strong>Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research</strong></p> <p>Randomized <a href="https://vial.com/glossary/clinical-trial/">clinical trials</a> are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. In the field of <a href="https://vial.com/glossary/clinical-research/">clinical research</a>, this pipeline can be broken down into several stages and processes specifically designed to rigorously validate the safety and efficacy of new drugs and treatments. The two broadest categories of drug development can be separated into the preclinical and clinical research stages. Within each of these, pharmaceutical and biotech sponsors are supported by preclinical and clinical <a href="https://vial.com/glossary/cro-contract-research-organization/">contract research organizations (CROs)</a> in clinical trials across various indications. Understanding how these two stages and types of CROs differ is fundamental to appreciating the intricate process of drug development. In this article, we will define preclinical and clinical CROs, as well as highlight the unique needs and challenges of these organizations in their respective stages of drug research.</p> <p><strong>What is a Pre-Clinical CRO?</strong></p> <p>The global preclinical CRO market was estimated to be valued at US$5.7 billion in 2022 and is projected to reach US$10.2 billion by 2030 at a compound annual growth rate (CAGR) of 7.5% over this period. Preclinical CROs are niche organizations that are tailored to conduct and manage the earlier stages of drug development when researchers are carrying out initial steps to discover a new drug or therapeutic intervention. Most notably, preclinical research can be distinguished by their need for a series of extensive laboratory testing performed on non-human models, such as cell cultures and animals. The rationale behind testing drugs in these lab-based experimental settings is to determine a reasonable conclusion of whether a potential drug is sufficiently safe and effective enough to be pursued in human trials.</p> <p>Some examples of services offered by preclinical CROs include, but are not limited to, the following:</p> <ul class="wp-block-list"><li>Drug screening or design control</li> <li>Compound synthesis or device manufacturing</li> <li>Toxicology</li> <li>Biocompatibility</li> <li>Maximum dosage studies</li> <li>Species expertise</li> <li>Regulation compliance</li></ul> <p><em>The Preclinical CRO’s Role in Drug Discovery</em></p> <p>In the early drug discovery stages of clinical research, preclinical CROs are responsible for designing and conducting laboratory tests, analyzing the resulting data, and confirming that the safety of the potential drug is suitable to proceed to the next stage of development. Given their role in identifying the potential risks and benefits of a new drug before it is evaluated on humans, the meticulous work of preclinical CROs is crucial for preventing harmful drugs from reaching the next stage, thereby protecting human subjects later in the drug development pipeline.</p> <p><strong>Overview of Clinical CROs</strong></p> <p>Clinical CROs, in contrast, are involved in the later stages of drug development, encompassing the more well-known stages of clinical research that involve testing a drug on human subjects from <a href="https://vial.com/glossary/phase-i/">phase I</a> to <a href="https://vial.com/glossary/phase-iii/">phase III</a> or <a href="https://vial.com/glossary/phase-iv/">IV</a> trials. The clinical phase of drug research is especially important because it tests the findings from preclinical studies in real-life conditions within the target disease population with human volunteers. Its importance is underscored by the 5-fold higher global market value for clinical CROs, compared with that of the preclinical CRO market, which was estimated to be US$50.55 billion in 2023 and is expected to grow at a CAGR of 7.0% between 2024 and 2030. This type of CRO includes world-renowned companies such as IQVIA, PPD, ICON, <a href="https://vial.com/?utm_source=organic">Vial CRO</a>, and more.</p> <p>Clinical CROs that support human trials offer an extensive range of services, such as the following:</p> <ul class="wp-block-list"><li>Site selection and set-up</li> <li>Clinical trial participant recruitment</li> <li>Regulatory affairs</li> <li>Monitoring</li> <li><a href="https://vial.com/glossary/pharmacovigilance/">Data management</a></li> <li><a href="https://vial.com/glossary/pharmacovigilance/">Pharmacovigilance</a></li> <li>Project management</li></ul> <p><em>The Clinical CRO’s Role in Drug Development</em></p> <p>Clinical CROs have the responsibility of designing and conducting clinical trials, collecting and analyzing the resulting data, as well as monitoring the safety and efficacy of drugs in human participants. The role of this type of CRO is pivotal in the drug development process to determine whether a new therapy is well-tolerated in the general population over a longer period of time. However, because clinical CROs are involved with studies that rely on human subjects, they must adhere to strict regulatory guidelines in each participating country of a trial, as set by bodies like the United States <a href="https://vial.com/glossary/food-and-drug-administration-fda/">Food and Drug Administration (FDA)</a>.</p> <p><strong>Preclinical vs. Clinical CROs: Comparing Needs and Challenges</strong></p> <p>Preclinical CROs conduct extensive laboratory testing on cell cultures and animal models to determine preliminary safety and efficacy results of potential drugs. To do this effectively, preclinical CROs require a well-equipped laboratory with advanced testing equipment and various animal models that are well-suited to translational drug research. There is also a need for experienced professionals who have the appropriate credentials and background in accurately interpreting experimental data. These CROs also need to be proficient in risk assessment because their role involves identifying potential risks and benefits of a new drug before it is tested on humans. One of the key challenges that accompanies this early phase of drug development is ensuring the preclinical CRO’s team of scientists select effective tests to accurately evaluate a new drug candidate. Others include the limited predictive value of animal or cell models, ethical concerns with animal testing, the limited availability of relevant experimental models, as well as the general resource-intensive nature of basic drug research.</p> <p>On the other hand, clinical CROs require robust data management systems and advanced statistical tools for data analysis, as well as effective communication systems to keep all stakeholders informed about the progress of the trial. Clinical trials must also be managed in such a way that the integrity of the resultant data is maintained with the highest quality. Because these trials involve human subjects, there is an added layer of complexity that involves navigating increasing complexities of regulatory guidelines as the clinical trials landscape becomes more globalized. One of the most daunting challenges faced by clinical CROs involves patient recruitment: more than 80% of clinical trials in the U.S. fail to meet their patient enrollment timelines and 30% of patients drop ou. Talent shortages, keeping pace with rapid advancements in technological innovations, including hybrid and decentralized trials, as well as maintaining projected study timelines are additional hurdles that face clinical CROs.</p> <p><strong>Conclusion</strong></p> <p>In conclusion, the roles of preclinical and clinical CROs are distinct but equally important in the drug development process. Preclinical CROs conduct initial laboratory testing on non-human models, identifying potential risks and benefits of new drugs, and ensuring their safety before they proceed to human trials. On the other hand, clinical CROs manage the later stages of development, conducting trials on human subjects and ensuring the safety and efficacy of drugs in real-world conditions. Despite the unique challenges they each face, both these types of CROs play pivotal roles in ensuring the successful development and validation of new drug therapies.</p> <p><strong>Vial: The CRO for Biotech, Powered by Technology</strong></p> <p><em>Our mission at <a href="https://vial.com/cro">Vial</a> as a global next-generation, tech-first CRO is to empower scientists to discover groundbreaking scientific therapeutics that help people live happier, healthier lives. We have built a sponsor-friendly, full-service clinical CRO powered by technology that enables us to deliver flexibility, cost-effectiveness, and reliability. <a href="https://vial.com/contact-us/">Contact a Vial representative today</a> to discover how we can make a difference for your next clinical trial</em></p>]]></content:encoded> <wfw:commentRss>https://vial.com/blog/articles/distinguishing-the-roles-of-preclinical-vs-clinical-cros-in-clinical-research/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Medidata vs. Vial | Pros and Cons</title> <link>https://vial.com/blog/articles/medidata-vs-vial-pros-and-cons/</link> <comments>https://vial.com/blog/articles/medidata-vs-vial-pros-and-cons/#respond</comments> <dc:creator><![CDATA[Owen Allen]]></dc:creator> <pubDate>Wed, 15 May 2024 20:50:27 +0000</pubDate> <category><![CDATA[Articles]]></category> <category><![CDATA[Biotech]]></category> <category><![CDATA[clinical trials]]></category> <category><![CDATA[CRO]]></category> <category><![CDATA[CRO's]]></category> <category><![CDATA[CROs]]></category> <guid isPermaLink="false">https://vial.com/?p=48930</guid> <description><![CDATA[Medidata vs. Vial | Pros and Cons The unprecedented consequences of the COVID-19 pandemic gave rise to the advent of decentralized clinical trials (DCTs), which are studies that use telemedicine and remote or local healthcare professionals to enable participants to join from different locations. As a result, the clinical research industry has slowly been shifting […]]]></description> <content:encoded><![CDATA[<p><strong>Medidata vs. Vial | Pros and Cons</strong></p> <p>The unprecedented consequences of the COVID-19 pandemic gave rise to the advent of decentralized <a href="https://vial.com/glossary/clinical-trial/">clinical trials</a> (DCTs), which are studies that use telemedicine and remote or local healthcare professionals to enable participants to join from different locations. As a result, the <a href="https://vial.com/glossary/clinical-research/">clinical research</a> industry has slowly been shifting from traditional randomized clinical trials (RCTs) to DCTs. To help facilitate this shift as smoothly as possible, technology <a href="https://vial.com/glossary/cro-contract-research-organization/">contract research organizations (CROs)</a> like Medidata and Vial CRO have been at the forefront of this transition, providing innovative digital solutions and tools. In this article, we will take a comparative look between both these leading companies to shed light on their experience and their suite of clinical trial technology. Read on to find out whether Medidata or Vial CRO is a better fit for your next study!</p> <p><strong>Medidata: A Journey of Innovation</strong></p> <p>Medidata Solutions, headquartered in New York City, was founded in 1999 by Tarek Sherif and Glen de Vries, who established the company to transform clinical trials with technology. This was a result of Sherif and de Vries noticing a significant unmet need for efficient <a href="https://vial.com/glossary/data-management/">data management</a> systems given the industry’s heavy reliance on time-consuming, costly, and error-prone processes. With this vision, they launched Medidata Rave <a href="https://vial.com/glossary/edc/">EDC (Electronic Data Capture)</a>, a cloud-based clinical data management system that has since revolutionized the industry by streamlining data collection, storage, and analysis. The long-standing worldwide success of Medidata Rave resulted in Medidata expanding their areas of focus, which now includes delivering solutions for study design, randomization, trial management, and patient engagement.</p> <p>In 2019, the company was acquired by Dassault Systèmes, a French software company, for $5.8 billion and now functions as a subsidiary. Today, Medidata’s digital solutions boast a staggering footprint in the clinical research industry. Of note, their Rave EDC is currently used by 19 of the top 20 global pharmaceutical companies, and it has powered more than 30,000 clinical studies involving over 9 million patients across nearly every country in the world. The 2023 report by Industry Standard Research also named Medidata’s Rave EDC as the most preferred EDC system used across the industry.</p> <p><strong>Vial CRO: A New Era in Clinical Research</strong></p> <p>Vial, on the other hand, was established in 2020 by Simon Burns and Andrew Brackin to serve as a platform to reimagine clinical trials by deploying technology at every step across multiple therapeutic areas. Headquartered in San Francisco, California, the rapidly growing company is supported by a robust team of nearly 200 employees, all of whom combine expertise ranging from clinical trial management and medicine to software engineering and product development. Recognizing the potential of digital tools in enhancing trial efficiency and data accuracy, Vial developed an eClinical platform that integrates all aspects of a trial including onboarding, patient enrollment, and data collection processes, providing a single, streamlined system. At the heart of this platform lies <a href="https://vial.com/edc/?utm_source=organic">Vial EDC</a>, a system integrated with Vial <a href="https://vial.com/esource/?utm_source=organic">eSource</a> (<a href="https://vial.com/glossary/electronic-source/">electronic Source</a>) and <a href="https://vial.com/epro/?utm_source=organic">ePRO</a> (<a href="https://vial.com/glossary/epro-electronic-patient-reported-outcome/">electronic Patient-Reported Outcomes</a>); this suite was designed to provide customizability and flexibility to meet the unique needs of different studies.</p> <p>In addition to its innovative technology, Vial places a strong emphasis on data security and regulatory compliance. The company’s software is fully encrypted and adheres to the latest regulatory guidelines, including the United States <a href="https://vial.com/glossary/food-and-drug-administration-fda/">Food and Drug Administration’s</a> <a href="https://vial.com/glossary/21-cfr-part-11-2/?utm_source=organic">21 CFR Part 11</a>, the <a href="https://vial.com/glossary/health-insurance-portability-and-accountability-act-hipaa-privacy-rule/">Health Insurance Portability and Accountability Act (HIPAA)</a>, and the General Data Protection Regulation (GDPR). In 2023 alone, they also announced several exciting updates to their ongoing vendor and sponsor partnerships, including the following:</p> <ul class="wp-block-list"><li><strong>Nielsen BioSciences, Inc</strong>: A San Diego-based biopharmaceutical company conducting a Phase III study on the safety and efficacy of CANDIN® for the treatment of common warts.</li> <li><strong>RecensMedical, Inc</strong>: A South Korea-based medical device company evaluating their OcuCool system to deliver cooling anesthesia for painless intravitreal injection therapy, for which Vial EDC has been enabling seamless patient enrolment.</li></ul> <p>With its tech-driven approach, commitment to security and compliance, and focus on meeting the unique needs of biopharma and biotech sponsors, Vial represents a new era in clinical research.</p> <p><strong>Medidata vs. Vial: A Matter of Fit</strong></p> <p><em>Decentralized Clinical Trial Capabilities</em></p> <p>Although both Medidata and Vial offer platforms which have considerable potential to support DCTs, the former stands out in this aspect with its dedicated DCT Program. Specifically, Medidata’s Rave Clinical Cloud platform utilizes a cloud-based platform that enables remote data access, allowing sponsors and CROs to conduct trials without geographical limitations. Their end-to-end DCT solution encompasses a wide range of tools [<a href="https://www.medidata.com/en/clinical-trial-solutions/virtual-clinical-trials/">14</a>]:</p> <ul class="wp-block-list"><li>Patient engagement: <a href="https://vial.com/glossary/econsent/">eConsent</a>, <a href="https://vial.com/glossary/ecoa/">eCOA (electronic clinical outcome assessment)</a>, Patient Insights, etc.</li> <li>Remote data oversight: Rave <a href="https://vial.com/glossary/what-is-a-ctms/">CTMS (clinical trial management system)</a>, Rave TSDV (targeted <a href="https://vial.com/glossary/source-data-verification-sdv/">source data verification</a>), Medidata Risk Management, etc.</li> <li>A real-time direct-to-patient (DtP) function to deliver medication to patients with ease</li></ul> <p>Although it does not cover the clinical trial lifecycle quite as extensively as Medidata, Vial’s clinical trial technology suite also offers similar support for DCTs. Its EDC platform enables real-time data capture from electronic <a href="https://vial.com/glossary/case-report-form-crf/">case report forms</a> (eCRFs), not only expediting trial performance, but also mitigating the risk of data loss like Medidata Rave. However, one of Vial’s most unique offerings relative to Medidata is its eSource tool. With its seamless integration into the Vial EDC system, clinical research sites can significantly reduce their time spent on data entry, eliminating double data entry required by systems like Rave EDC, while further minimizing human errors. Therefore, the Vial platform delivers additional measures to bolster data quality, on top of enabling similar remote data monitoring and source verification capabilities as Medidata. Learn more <a href="https://vial.com/blog/articles/comparing-vial-cros-edc-to-industry-giants/?utm_source=organic">here</a> about how Vial CRO’s EDC compares to those of industry giants.</p> <p><em>Operation Across Therapeutic Areas</em></p> <p>Medidata is fully focused on delivering top-notch digital solutions and products across a variety of different disease indications for large biopharma companies, medical device sponsors, as well as academic and not-for-profit organizations. Similarly, Vial is a full-service CRO that provides digital tools for facilitating efficient clinical trial experiences for sponsors, sites, and patients alike. However, it also offers separate teams of experts and <a href="https://vial.com/glossary/clinops-clinical-operations/">ClinOps (Clinical Operations)</a> professionals for each of their nine specialty CROs: <a href="https://vial.com/cro/oncology/">Oncology</a>, <a href="https://vial.com/cro/dermatology/">Dermatology</a>, <a href="https://vial.com/cro/ophthalmology/">Ophthalmology</a>, <a href="https://vial.com/cro/gastroenterology/">Gastroenterology</a>, <a href="https://vial.com/cro/neurology/">CNS (Central Nervous System)</a>, <a href="https://vial.com/cro/cardiology/">Cardiology</a>, <a href="https://vial.com/cro/medical-device/">Medical Device</a>, <a href="https://vial.com/cro/rare-disease/">Rare Disease</a>, and <a href="https://vial.com/cro/digital-therapeutics/">Digital Therapeutics</a>. It is worth noting that, given Medidata’s vast experience in the industry, their products have been used in trials across several therapeutic areas over the years, but not with the same level of in-house tailored medical expertise as provided by Vial. Overall, both companies offer vast coverage of different conditions, but Vial may be a better fit for sponsors looking for additional specialized guidance in specific disease indications.</p> <p><em>Management and Other Features</em></p> <p>The management team at Medidata comprises accomplished professionals with rich experience in the healthcare and technology sectors. The company also offers the following key features:</p> <ul class="wp-block-list"><li>Risk-based monitoring, which optimizes the use of resources and improves data quality</li> <li>Advanced randomization and trial supply management, which ensures the right patients receive the right treatments at the right time</li> <li>A robust patient portal, which enhances patient engagement and enables patient-centered trials</li></ul> <p>On the other hand, Vial is made up of a unique blend of innovators, engineers, and ClinOps leaders. They also provide thorough end-to-end audit trails to ensure data transparency and accountability, as well as extensive data export capabilities to support data sharing and convenient analysis.</p> <p><strong>Conclusion</strong></p> <p>Medidata and Vial CRO are two leading clinical trial technology companies that have been pivotal in the transition from traditional RCTs to hybrid and decentralized clinical research. Whereas Medidata offers robust technology solutions for the entire clinical trial lifecycle, in addition to its long-standing reputation in the industry, Vial is a newer player with its innovative EDC technology that delivers efficiency, security, and affordability all at once. Medidata stands as a reliable choice for sponsors seeking solutions that have stood the test of time with a robust portfolio of success. However, Vial represents a promising prospect in the field, providing similar features with greater cost-effectiveness and user-friendliness with its customizable platform. Ultimately, the decision between these two companies and their plethora of digital tool offerings will depend on the specific needs, resources, and strategic direction of the sponsor and their clinical trial team.</p> <p><strong>Vial: The CRO for Biotech, Powered by Technology</strong></p> <p><em>Our mission at <a href="https://vial.com/cro">Vial</a> as a next-generation, tech-first CRO is to empower scientists to discover groundbreaking scientific therapeutics that help people live happier, healthier lives. <a href="https://vial.com/contact-us/">Contact a Vial representative today</a> to discover how we can make a difference for your next clinical trial!</em></p>]]></content:encoded> <wfw:commentRss>https://vial.com/blog/articles/medidata-vs-vial-pros-and-cons/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>First in Human Episode #62 featuring Josh Mandel-Brehm</title> <link>https://vial.com/blog/podcast/first-in-human-episode-62-featuring-josh-mandel-brehm/</link> <comments>https://vial.com/blog/podcast/first-in-human-episode-62-featuring-josh-mandel-brehm/#respond</comments> <dc:creator><![CDATA[Owen Allen]]></dc:creator> <pubDate>Tue, 14 May 2024 20:36:42 +0000</pubDate> <category><![CDATA[Podcast]]></category> <category><![CDATA[clinical trials]]></category> <category><![CDATA[CRO]]></category> <category><![CDATA[Drug Discovery]]></category> <guid isPermaLink="false">https://vial.com/?p=48879</guid> <description><![CDATA[Amy Del Medico: Hi everyone, I’m Amy del Medico and I’m here today with Josh Mandel-Brehm from CAMP4 Therapeutics. Josh, welcome, would you like to give a little introduction on yourself? Josh Mandel-Brehm: First of all, thank you very much for having me, Amy. It’s a pleasure to join you today. I’m Josh Mendel-Brehm. I’m […]]]></description> <content:encoded><![CDATA[<p><strong>Amy Del Medico:</strong> Hi everyone, I’m Amy del Medico and I’m here today with Josh Mandel-Brehm from <a href="https://www.camp4tx.com/">CAMP4 Therapeutics</a>. Josh, welcome, would you like to give a little introduction on yourself?</p> <p><strong>Josh Mandel-Brehm:</strong> First of all, thank you very much for having me, Amy. It’s a pleasure to join you today. I’m Josh Mendel-Brehm. I’m the CEO of CAMP4. Prior to CAMP4, I was at Biogen and Genzyme in business development and strategy roles. I’m really looking forward to talking with you today about CAMP4.</p> <p><strong>Amy Del Medico:</strong> Great, thank you. Could you give us some background on CAMP4 Therapeutics and maybe touch on the meaning of the unusual name?</p> <p><strong>Josh Mandel-Brehm:</strong> Yeah, absolutely. When people ask that question. Camp 4 is the last camp before the top of Everest. It’s also a sacred ground in Yosemite National Park, where all the world’s best rock climbers come to push the boundaries of what’s possible. Aspirationally, we think of CAMP4 as pushing the boundaries of what’s possible in order to make better treatments for patients.</p> <p>That was something where we felt very strongly that it wasn’t grounded in a scientific name, but more of an aspirational name, because we have big intentions for what we can do with our platform. On that note what is CAMP4? CAMP4, in its simplest form, is using what’s called antisense oligonucleotides, a form of chemistry, to very specifically increase the expression of genes.</p> <p>How we do this is an area of biology called regulatory RNAs. These are RNAs that come out of our non-coding genome. So they come out of enhancers and promoters. They have two really important features. One is they act on nearby protein coding genes to control the expression of those genes and they act within what we say a physiological range. They allow for increases or decreases to genes. In a range that the cell can handle. A safe range, if you will. Avoiding toxicity.</p> <p>I like to think of regulatory RNAs as built in specificity. What we have discovered at CAMP4 is that when we find a regulatory RNA that is influencing the expression of a gene tied to disease, we can drug that regulatory RNA with an antisense oligonucleotide in a very specific way.</p> <p>We can increase the expression of the remaining healthy gene, which then allows us to go after a range of diseases that have a genetic basis where you’re missing a little bit of protein and the difference between being sick or healthy can be putting that little bit of missing protein back into the system.</p> <p><strong>Amy Del Medico:</strong> Interesting, thank you for the background, it sounds like it could be applied to a broad range of different indications.</p> <p><strong>Josh Mandel-Brehm:</strong> The biology itself extends to any different tissue in the body. I referred to this before, but, there’s an entire category of diseases that are either haploinsufficient, meaning one of your genes no longer works, but one is still remaining to be healthy. You’re missing 50 percent of protein to be healthy or parcel lots of function. You have a mutated enzyme that kind of works, but not enough. </p> <p>Essentially there’s hundreds of these diseases where there are no approved treatments. What we’ve chosen to do is apply our platform at first into metabolic diseases. That is the liver based diseases or certain parts of the brain. The reason for that is we know we can deliver this type of chemistry and to since all the nucleotides safely and effectively to those two tissues, which have a lot of diseases that have a genetic basis and are still in need of treatments.</p> <p><strong>Amy Del Medico:</strong> You’ve touched on it a little bit, but can you walk us through in more detail how the RAP platform works and how it amplifies mRNA and increases healthy gene expression?</p> <p><strong>Josh Mandel-Brehm:</strong> Yeah, absolutely. Our bread and butter is really what we call mapping cells. What this means is we take a human cell type. For example, in the liver, we’ll take Hepatocytes. We will apply a whole range of different next generation sequencing technologies that will generate billions of different wet lab biological data points.</p> <p>To make sense of that information, we actually have a data science team that has built algorithms that can then take all that information and turn human gene expression into an in silico exercise. What I mean by that is once we map a cell. Any gene that is being expressed, so the liver has maybe 11,000 protein coding genes, whatever gene you’re interested in, we can very rapidly show you how the DNA is controlling that gene.</p> <p>From that information, we can pick out the RNA, the regulatory RNA that is controlling a gene of interest. That’s step one, when we apply our RAP platform, which is the RNA actuating platform. Once we have a target gene in mind, so a gene that has an underlying disease where we want to increase its expression to put more protein back into the body, we can then screen the sequence of that gene, that regulatory RNA using antisense oligonucleotide. </p> <p>This is a very tried and true chemistry. It was pioneered by the likes of Ionis and Alnylam, two very established, successful companies that have approved drugs on the market. We’re using the same type of chemistry that allows us to make a very programmable and rationally designed antisense oligonucleotide that we can then deliver as a therapeutic to the patient where we want to increase gene expression to essentially shift them from an unhealthy state to a healthy state.</p> <p><strong>Amy Del Medico:</strong> I know with your development program, you’re focusing on urea cycle disorders, which can be quite complex and severe conditions. I wonder why you decided to choose that particular therapeutic area.</p> <p><strong>Josh Mandel-Brehm:</strong> Not [00:05:00] surprisingly, there are lots of different diseases we could theoretically apply our platform to, again, with a genetic basis. What are the things we think about when we choose diseases to work on? We’d like to work on as many as possible, of course, but we are a smaller biotech, and so we have to be judicious with our resources.</p> <p>One thing we think about is, “Okay, what is the genetic basis of the disease? Is there strong evidence that if we increase the expression of a target gene, even by a little bit, it’ll have a dramatic effect in helping patients?” The second thing we think about is, “The path to the clinic and how quickly and efficiently can we actually prove out our thesis in the human setting?”</p> <p>And that’s really important because sometimes the science is beautiful, but you can’t find the patients, or the science is beautiful, but you have to do a very long study to prove it out, or you need to find thousands of patients, which you’d wish to do, but again, as a smaller company, you have to be really thoughtful.</p> <p>We try and find diseases where there’s an unmet need. There’s a strong genetic basis, and we think we can at least do the first clinical study to show that our drug works. And then the last piece is, of course, is there a commercial market there? That’s really a lineup of what’s the unmet need. What do we think our drug can do in terms of its transformative impact?</p> <p> What does competition look like? In the case of urea cycle disorders, this is a disease that has many different subtypes. Meaning there are six enzymes that work together to essentially break down ammonia. For all of us that are walking around healthy, we have an intact healthy urea cycle.</p> <p>If you’re unlucky enough to have a mutated enzyme in this cycle, although you may retain some partial activity, it’s not enough to prevent the buildup of ammonia, which leads to all kinds of neurological side effects. It can lead to death very young. The idea for <a href="https://www.camp4tx.com/">CAMP4</a> would be if we can increase the rate at which the cycle can break down ammonia to urea we can have a massive impact for these patients and not just one subtype, but almost all the subtypes of urea cycle disorder patients. </p> <p>We have a strong belief based on the genetics that a small increase could lead to a big impact. We know that we can do a pretty efficient, healthy volunteer study, even though they’re not sick, but we have an assay we can look at to measure the rate of ureagenesis. We know that will allow us to essentially set parameters to go directly into patient studies. And, that this is a disease, although it’s rare 5-10,000 patients in the U. S. have it, it’s a really crummy disease. And these patients are badly in need of a therapeutic. We like that from a commercial perspective where we think our drug can become a backbone therapy for these patients that so badly need new medicines.</p> <p><strong>Amy Del Medico:</strong> And are your clinical trials focusing on just one of the subtypes? So you mentioned it could potentially work on all, are you looking at multiple subtypes?</p> <p><strong>Josh Mandel-Brehm:</strong> We’re looking at multiple cell types. That’s the grand vision for the drug. The way that we think about that is, in this case, it is a partial loss of function. It’s not a haploinsufficient disease, meaning most of the patients, regardless of their mutation, they retain some activity. So we know there’s an opportunity to boost that activity.</p> <p>What we’ve done is we’ve chosen a rate limiting enzyme. So the first enzyme in the urea cycle that’s rarely mutated is that if you increase that enzyme, the first thing it does is immediately allows more ammonia to be converted. And the second thing it does is it actually boosts the expression or the mRNA approaching of additional downstream enzymes. We get a double impact from working on that particular enzyme. That, theoretically, allows us to go up to the great majority of patients, despite having different mutations, if you will. </p> <p>One other comment, it would seem obvious to go directly into patients with our drug. However, we felt that actually going into healthy volunteers. Normal people who have a healthy intact urea cycle would be the way to go because 1: it would allow us to ensure the drug is safe. These patients have very fragile levers. The second thing is, it would allow us to actually be able to deploy a new type of assay, a relatively new assay called the ureagenesis rate test.</p> <p>That is a way of measuring the activity to convert ammonia to urea, which is a stable isotope. You want to get out of your body. Essentially, it would allow us, even though it takes a step before you get in patients in the long run, it allows us to have tools that we think can facilitate regulatory discussions that can allow us to better measure the activity of our drug and patients and essentially move more quickly towards an approvable product in the future. Because that’s our ultimate goal to get there as quickly as possible for patients in a safe way.</p> <p><strong>Amy Del Medico:</strong> Interesting. So you’re almost starting to develop your own endpoint.</p> <p><strong>Josh Mandel-Brehm:</strong> So, there is an approvable endpoint by the regulatory agencies. That is the reduction of ammonia, which would make sense because that’s the culprit that ultimately leads to symptoms. But the more tools that we have to show a benefit in patients and help patients, the better it is in terms of our own probability of success and making sure we’re running the best studies.</p> <p>Whether or not it becomes an approvable endpoint tool, we’ll see, but at the very least, it’s another tool we can use to the benefit of ourselves as well as patients.</p> <p><strong>Amy Del Medico:</strong> I wondered if you could explain to our audience the dark genome and how it’s being used to develop treatments for diseases.</p> <p><strong>Josh Mandel-Brehm:</strong> Disclaimer: I did not come up with a dark genome. I think that is a phrase that others have used. We’re happy to be included in that. [00:10:00] I’d say it’s a very broad term and said simply, of our DNA 2% give or take of our DNA encodes for genes that make proteins. The other 98% of our genome does not make proteins. It makes all different types of important functional outputs that control the expression of genes. The more and more we dig deeper into that is the dark genome. The more we study it, the more we find it’s a very important part of how our bodies control cell fade, cell differentiation, gene expression. </p> <p>For our particular purposes, we are studying the areas of the dark genome that are enhancers or promoters, specifically. That actually makes a type of regulatory RNAs. It does not code for proteins. These RNA’s turn out to have a very important function in controlling the expression of nearby protein coding genes. The 2%, if you will, of genes in our body. A fun fact is although we only have 20 to 25,000 protein coding genes, the same gene can be expressed in different cells. How is that? The way cells get specific gene expression is because of enhancers. We have many more enhancers compared to the genes themselves and the enhancers are where the RNAs come out of.</p> <p>That turns out to be a very important part of the dark genome. There are other companies that are studying it, because if there are mutations in those regions, they can lead to disease. We agree with that as well. There’s all types of opportunities leading to new targets or new ways of interpreting disease by studying the dark genome despite the fact that diseases are typically looked at as mutations, in particular.</p> <p><strong>Amy Del Medico:</strong> It sounds like a complex and quite novel approach. I imagine there were quite a lot of challenges in developing your therapeutic CMP-CPS-001. How do you address those challenges? And can you pick out any in particular that have been a problem for you?</p> <p><strong>Josh Mandel-Brehm:</strong> I always thought problems create opportunities. We always try to look at it in that way. Part of what we’re doing is novel in this. That’s our big part of it. We’re the first company that’s really taking antisense oligonucleotides and instead of down regulating or degrading proteins or enzymes that are muted and you don’t want in your body, we’re doing the opposite.</p> <p>We’re using that technology to actually act on healthy genes and increase gene expression. That’s a completely novel way of thinking about the technology and really opens the aperture for a technology that has been proven to be safe and effective in approved products and is in many products in the clinic. But again, only in one half side of the coin, that is the downregulation aspect of it. Now, all of a sudden, we’re taking something that is proven to be a therapeutic and we’re teaching it a whole new way that it could be used to treat disease. </p> <p>The way we thought about it was, we can’t get tenfold increases in gene expression. There are diseases where you really have to put a lot back in the system. That seems like a problem. On the other hand, there are hundreds of genetic diseases where, actually, you only want to increase the gene a small amount, and over-expressing the gene could lead to toxicity.</p> <p>This area of biology does not really want to allow for overexpression. It’s like a built-in safety feature. So, in this case, we took that challenge into an opportunity set, which is, this is perfect for all these haplodeficiency diseases. We don’t have to worry about overexpression.</p> <p>That’s not a major area of concern. We’re much more focused on designing a drug that is specific to the RNA that controls the gene. We’re highly confident that if we could make a version that is safe, it should have a big impact in the clinic, but that’s what we’ll be proving out. I say that based on our preclinical data. That’s an example. I think of a challenge where we took what the biology was doing. Instead of trying to make it do something it didn’t want to do, we just directed it into a set of diseases where it fit perfectly from our perspective. That’s just one example.</p> <p><strong>Amy Del Medico:</strong> Excellent. Thank you. We’ve mentioned that there’s a potential range of therapeutic applications. I wondered if beyond the UCD space, are there any other genetic diseases that CAMP4 is exploring? </p> <p><strong>Josh Mandel-Brehm:</strong> Yeah, absolutely. In the metabolic space, our first program is for urea cycle disorders, and we are in the clinic administering that drug. Our next program is for a very interesting target. It’s the LDL receptor. This is a very competitive area. Actually, there are many approved drugs in this area, for example, statins, therapies, there’s also an RNAi that’s been approved for it, as well. There are millions of people walking around some of the genetic basis that have LDL levels that essentially put them at high risk for cardiac events. Now, in a decent amount of those patients statins have been a very effective treatment.</p> <p>PCSK9 is another effective way to do that. Those are more recent, therapeutics that are based on genetics, by the way. Yet, still, there are many patients that their LDL levels are remaining way too high. Or they’re not responding or they have side effects from those other drugs I mentioned.</p> <p>And so maybe they can take 1, but not the other. So essentially, there remains a pretty big opportunity, despite the fact they’re approved drugs that if you can come up with other ways to remove LDL, you could help millions of people. Our approach is, in fact, to directly upregulate the receptor that ingests that LDL and removes it from the system.</p> <p>It’s a very clever way to essentially go about solving the problem. We think that could be a really [00:15:00] important treatment regimen in the context of the other treatments that are out there as well. Again, that’s because there’s still many people that need to lower those LDL levels. That’s another example of a metabolic program, and both those programs are subcutaneous delivery. They’re not infusion. They’re injection. Which is really important, especially given the fact that many of these patients don’t want to go through infusions. very cumbersome for them. That creates an opportunity.</p> <p>Now, in the central nervous system, one area that we’re very keen to work on is, genetic epilepsies. There are many different types of genetic epilepsies, for example, Gervais syndrome, sYNGAP, SCN2A, where these are haploinsufficient, one gene is no longer functioning, one gene is still functioning. Essentially you’re missing 50% of protein to be healthy. </p> <p>We have pretty high confidence that if you can shift expression, even by just 50%, meaning you put people back up to the 75% level based on genetics. But this is going to have a pretty big impact for patients, and we would call it disease modifying. Most of these diseases have no approved treatments. Some do, but a lot don’t. These patients are really suffering. The caregivers are suffering. Probably because nobody’s really ever found a way to address these diseases. Either because not all modalities get into the CNS. Or, it’s very hard to do this with small molecules.</p> <p>Our approach of identifying a regulatory RNA that can control these genes that are underwriting the diseases using antisense oligonucleotides delivered intrathecally, that is through the lumbar puncture, just like the approved job spin browser for spinal muscle atrophy and diversion for ALS is a really nice way to essentially get the drug to the target where these patients have no other treatments and essentially are suffering from all types of different comorbidities, including seizures. That’s the next category of diseases we’re building in the brain behind those metabolic programs. </p> <p><strong>Amy Del Medico:</strong> Josh, thanks for the in depth answer. Really appreciate it. I’ve got one last question for you. Looking ahead, I wondered what excites you the most about mRNA amplifying therapeutics?</p> <p><strong>Josh Mandel-Brehm:</strong> The entire purpose of our company is to make drugs for patients. The more we get into this, the more we learn about different diseases where we think our technology could be applicable. Yeah. And so what really excites me is that if we’re able to convince people that this is not only a fundamental area of biology that we can take advantage of to make many new drugs, but that CAMP4 has the ability to make those drugs.</p> <p>We know we can’t do it all on our own. We will absolutely shepherd things forward using our capital and resources. But, I hope that it brings to bear other partnerships with bigger and smaller companies so that we can take advantage of our platform and essentially bring more drugs to patients CAMP4 can do on its own.</p> <p>I think that’s really our big vision here. We want to create the next great platform pipeline company. We know we can’t do it on our own, but, we think if we continue to show promising data that will bring to bear other ways of creating opportunities to bring drugs to patients.</p> <p><strong>Amy Del Medico:</strong> Amazing. Thank you, Josh, so much for your time and for the very interesting discussion. Appreciate it.</p> <p><strong>Josh Mandel-Brehm:</strong> Thank you. It was a real pleasure to speak with you today.</p>]]></content:encoded> <wfw:commentRss>https://vial.com/blog/podcast/first-in-human-episode-62-featuring-josh-mandel-brehm/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Decoding Clinical Trial Costs and Efficiency Roadblocks</title> <link>https://vial.com/blog/articles/decoding-clinical-trial-costs-and-efficiency-roadblocks/</link> <comments>https://vial.com/blog/articles/decoding-clinical-trial-costs-and-efficiency-roadblocks/#respond</comments> <dc:creator><![CDATA[Owen Allen]]></dc:creator> <pubDate>Mon, 13 May 2024 20:51:33 +0000</pubDate> <category><![CDATA[Articles]]></category> <guid isPermaLink="false">https://vial.com/?p=48869</guid> <description><![CDATA[Introduction The biopharma industry is poised to make revolutionary advances in and redefine drug development, and the current climate for innovation appears ideal. However, progress from molecule to approved drug is hampered by extremely high costs and lengthy clinical trials, and approximately 90% of drugs that reach clinical trials fail. We explore the causes underlying […]]]></description> <content:encoded><![CDATA[<h2 class="wp-block-heading">Introduction</h2> <p>The biopharma industry is poised to make revolutionary advances in and redefine drug development, and the current climate for innovation appears ideal. However, progress from molecule to approved drug is hampered by extremely high costs and lengthy <a href="https://vial.com/glossary/clinical-trial">clinical trials</a>, and approximately 90% of drugs that reach clinical trials fail. We explore the causes underlying the high costs associated with drug development and what value <a href="https://vial.com/glossary/cro-contract-research-organization">contract research organizations</a> (CROs) bring to sponsors in addressing these issues.</p> <h2 class="wp-block-heading">Clinical Trials: Slow and Remarkably Expensive</h2> <p>A recent<a href="https://www.mckinsey.com/industries/life-sciences/our-insights/accelerating-clinical-trials-to-improve-biopharma-r-and-d-productivity"> McKinsey analysis</a> found that although research and development (R&D) spending increased 44% from $170 billion in 2012 to $247 billion in 2022, the number of US novel drug approvals remained flat at 43 per year. These findings indicate that R&D productivity, measured by the number of US novel drug approvals vs. R&D spending, is decreasing, and an estimated cost per novel asset is as high as $2.8 billion. According to Rodríguez-Molinero et al., only 5% of molecules in oncology <a href="https://vial.com/glossary/phase-i">Phase I</a> trials reach the market taking, on average, 7.5 years.</p> <h2 class="wp-block-heading">Length and Cost of Clinical Trials</h2> <p><a href="https://www.mckinsey.com/industries/life-sciences/our-insights/accelerating-clinical-trials-to-improve-biopharma-r-and-d-productivity">McKinsey’s analysis</a> compared the average length of Phase II clinical trials between 2011 – 2015, when it was 41 months, and 2016 – 2021, when it lengthened to 44 months. For Phase II trials, the average clinical trial lengthened from 37 to 41 months between the two periods.</p> <p>A 2016 study by <a href="https://pubmed.ncbi.nlm.nih.gov/26908540/">Sertkaya</a> et al. estimated the average cost of a Phase I study in the US to range from $1.4 million (pain and anesthesia) to $6.6 million (immunomodulation); Phase II study cost ranged from $7.0 million (cardiovascular) to $19.6 million (hematology); and <a href="https://vial.com/glossary/phase-iii">Phase III</a> study cost ranged from $11.5 million (<a href="https://vial.com/glossary/dermatology/">dermatology</a>) to $52.9 million (pain and anesthesia). The study found that therapeutic area is a significant cost determinant. Across all study phases, the top cost drivers were costs associated with clinical procedure, admin staff, and site monitoring.</p> <p>In 2021, a review by <a href="https://pubmed.ncbi.nlm.nih.gov/35170336/">Rennane et al.</a> found that the R&D cost per drug ranged from $113 million to just over $6 billion (in 2018 dollars) for all new drugs, new molecular entities, and drugs in specific therapeutic classes. For new molecular entities, the per-drug cost ranged from $318 million to $2.8 billion. A World Health Organization (WHO) 2022 study estimated that the average cost to develop a new drug ranges from $43.4 million to $4.2 billion.</p> <h2 class="wp-block-heading">What contributed to the cost being so high</h2> <p>Cost drivers of R&D of new drugs include the <a href="https://vial.com/blog/articles/drug-development-costs-explained-why-is-it-so-expensive/?https://vial.com/blog/articles/top-5-challenges-in-running-global-multi-region-clinical-trials/">industrial, regulatory, and policy environment, process development, and manufacturing cost contributions</a>. In addition, an estimated 90% of clinical drug development efforts fail, and R&D costs are affected by investment size in different development phases, duration, and phase success rates. Further, the duration and success rates depend on the type of technology used and therapeutic indication. Another cost driver is capitalization, whereby R&D costs are adjusted using a cost of capital rate to reflect the return required for investment.</p> <p>The McKinsey analysis found that R&D productivity remains low. Several factors contributing to low R&D productivity were identified, including</p> <ul class="wp-block-list"><li>low success rates, as only approx. 13% of assets that enter Phase I progress to eventual launch.</li> <li>Development costs remain high (60 – 70% of total costs).</li> <li>Development cycles are long (on average, 12 years to develop a novel medicine) and getting longer.</li> <li>An estimated 80% of clinical trials do not finish on time.</li></ul> <p>As indicated by Chertman, the cost of running randomized controlled trials (RCTs) has increased due to the lengthening of trial durations as <a href="https://vial.com/glossary/clinical-research">clinical research</a> is increasingly focused on chronic diseases, the fragmentation among vendors and service providers, e.g., tech solutions companies, and overcollection of data.</p> <h2 class="wp-block-heading">What are CROs doing to deliver for sponsors?</h2> <p>Many sponsors needing to accelerate large trials and reduce costs outsource to <a href="https://vial.com/blog/articles/why-do-pharma-companies-outsource-to-cros/">CROs with established protocols, global reach, and therapeutic area expertise.</a> CROs tackle clinical trial management challenges by providing sponsors with strategic site identification, selection, and activation, in addition to efficient patient recruitment and onboarding. Throughout the trial, CROs provide comprehensive on-site management and robust data quality and management while facilitating clear communication and collaboration among stakeholders. To improve efficiency and R&D productivity, CROs also stay up-to-date with and integrate appropriate tech. CROs bring their expertise in regulatory compliance and are adept at adapting to changing environments. Some CROs believe that widespread risk-based monitoring would substantially reduce study costs and suggest that the US <a href="https://vial.com/glossary/food-and-drug-administration-fda">Food and Drug Administration</a> (FDA) encourage its use.</p> <p>The McKinsey study highlights opportunities for improving R&D productivity – pointing out that durations are typically fixed and study startup and close-out account for only a small part of the overall duration. As such, the researchers suggest that the most promising opportunity to accelerate trials is to improve the speed and efficiency of trial <a href="https://vial.com/glossary/enrollment/">enrollment</a>. CROs can deliver value to sponsors by:</p> <ul class="wp-block-list"><li>Applying innovative trial designs, e.g., using statistical innovation and predictive modeling to reduce the total study participants required</li> <li>using real-world evidence (RWE) to supplement participants’ data</li> <li>using patient-burden protocol assessments, predictive models, and patient and investigator panels or surveys to make informed choices, optimize study design, and develop simpler, patient-centric protocols.</li> <li>using data and analytics for site selection and management as McKinsey analysis indicates that AI-driven models can typically identify opportunities to accelerate recruitment by 15 – 20%</li> <li>increasing participant convenience and adjusting the point of delivery for trials through, e.g., hybrid trial design, which includes home visits, telemedicine, pharmacy visits, and mobile units.</li> <li>Improving site experience, which, according to McKinsey’s data, is positively correlated with trial enrollment and patient retention</li></ul> <h2 class="wp-block-heading">How is Vial specifically working to reduce the length and cost of clinical trials</h2> <h3 class="wp-block-heading">Pricing</h3> <p>Understanding sponsors’ challenges and financial risks, Vial CRO offers <a href="https://vial.com/white-papers/one-pager-vial-fixed-pricing">fixed-fee pricing</a>, a pricing model whereby sponsors are charged a flat fee for the entire clinical trial. At Vial, a fixed-fee pricing model applies to all contracts and helps sponsors stay on budget and free of costly unanticipated change orders.</p> <h3 class="wp-block-heading">Study Startup</h3> <p>The McKinsey study reported that best-in-class timelines for study startup are about two months. <a href="https://vial.com/blog/articles/study-startup-optimization">Vial CRO has developed a centralized study startup optimization process that can expedite trial initiation</a>, where the goal is to have all study sites activated within 30 days of feasibility. Vial CRO’s Site Startup Platform enables sites to seamlessly onboard to trials, eliminating administrative burdens and increasing progress transparency.</p> <h3 class="wp-block-heading">Improving site experience</h3> <p>The Vial Technology Platform leverages connected systems and intuitive design to run global trials efficiently at scale. The connected system comprises the Site Startup Platform, Electronic Source (<a href="https://vial.com/glossary/electronic-source">eSource</a>) Platform, in-house <a href="https://vial.com/glossary/edc">electronic data capture</a> (EDC), and <a href="https://vial.com/glossary/epro-electronic-patient-reported-outcome">electronic patient-reported outcomes</a> (ePRO).</p> <p><a href="https://vial.com/contact-us/">Contact us today</a> to discover how we can make a difference for your next clinical trial!</p>]]></content:encoded> <wfw:commentRss>https://vial.com/blog/articles/decoding-clinical-trial-costs-and-efficiency-roadblocks/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> </channel></rss> If you would like to create a banner that links to this page (i.e. this validation result), do the following:
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