DCRI Study Shows Limited Use of Open Trial Data Platforms
The study authors surmised that the lack of validation studies of initial trial results reflected that one goal of open access is not being met. Further, they believe that the limited use indicates a “failure to get the word out “ to researchers.
Duke Clinical Research Institute (DCRI) examined the early use of platforms designed to provide access to individual patient data, developed to increase transparency of clinical trial data, and found the use has been limited. The DCRI team explored three open access platforms – ClinicalStudyDataRequest.com, the Yale University Open Data Access Project (YODA), and the Supporting Open Access for Researchers (SOAR) initiative – to determine how many clinical trials were publicly available to investigators and how these open trial data were being used. Although more than 3,000 trials are currently available, only 15.5% had been requested. Most proposals did not focus on validating the primary results of the trial, instead suggesting secondary uses such as epidemiological studies, subgroup analyses, analyses of the disease state, or predictors of treatment response.
In a release, the study authors surmised that the lack of validation studies of initial trial results reflected that one goal of open access is not being met. Further, they believe that the limited use indicates a “failure to get the word out “ to researchers.
Ann Marie Navar, MD, PhD, the study’s lead author, told Applied Clinical Trials in an email response that they believe the reasons for lack of validation studies of original results is due to three economic factors. “There are no mechanisms in place to fund this type of research. Next, there may not be much scientific incentive to do this work. Studies that confirm the primary analyses are unlikely to be published in high-impact journals. Finally, as demonstrated by the variety of other projects being conducted using these data, researchers are more interested in their own original scientific questions than repeating others' analyses.”
Dr. Navar also responded that the publication of studies such as theirs, will help improve visibility of the platforms. “We also hope that as the studies using these data are completed that they acknowledge the mechanism through which data were accessed. To date, only one analysis has resulted in a publication. As more studies are completed and published, visibility should increase.”
The results were published in the March 22 issue of the Journal of the American Medical Association (JAMA).
Read the full press release here.
Related articles
http://www.appliedclinicaltrialsonline.com/behind-clinicalstudydatarequestcom-pharma-transparency
http://www.appliedclinicaltrialsonline.com/transcelerate-s-data-transparency-initiative
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
