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Durham, North Carolina – March 22, 2016 – The DCRI announced today results from a study demonstrating that early use of platforms designed to provide access to individual patient data and developed to increase transparency of clinical trial data has been limited. The results were published in the March 22 issue of the Journal of the American Medical Association (JAMA).
The 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 percent of these 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.
“We found that researchers are accessing data mainly to conduct secondary analyses, as opposed to validation studies of the initial trial results,” said Ann Marie Navar, MD, PhD, the study’s lead author. “While the science currently being conducted with these data reflects the wealth of information in the databases, it may not be meeting the goals of proponents of open access.”
“Overall the limited use of the three open access platforms to date indicates a failure to get the word out,” said DCRI Executive Director Eric Peterson, MD, MPH. “As we move forward, it will be important to create more simple means of linking these data across trials and providing researchers with grant support opportunities.”
Investigators interested in accessing data must submit a research proposal to the relevant platform, which is reviewed for the availability of the trial(s) requested and completeness of the application. The proposal is then reviewed by a panel of independent experts or members of the platform, which rejects or approves the proposal based on scientific merit and adequacy of the research design to achieve scientific objectives. Once approved, a data sharing agreement is created and data are shared with researchers. Sponsors depositing data in ClinicalStudyDataRequest.com, YODA, and the SOAR initiative include GlaxoSmithKline, Astellas, Boehringer Ingelheim, Eisai, Eli Lilly, Novartis, Roche, Sanofi, Takeda, Union Chimique Belge, ViiV Healthcare, Johnson & Johnson, Medtronic, and Bristol-Myers Squibb.
The team reviewed all proposals with data use agreements since the inception of each platform, the characteristics of accepted proposals, and reported publications. The team then classified the main objective of the analysis based on review of the analytic plan and study design.
A total of 3,255 clinical trials were available in the platforms. There were 234 proposals submitted, of which 177 were processed and met initial requirements. Only 6.8 percent of proposals that made it to the review panel were rejected. Ultimately, data sharing agreements were completed for 113 studies. This included requests from 17 countries, most from the United States (n = 61; 54.0 percent). Most studies were not directly funded (n = 77; 68.1 percent).
Only 505 unique trials (15.5 percent of available trials) were requested, including 356 phase III trials (24.7 percent of phase III trials available). The analytic goals of these proposals varied, including secondary analyses of a trial’s treatment effect (n = 50; 44.3 percent) and evaluating predictors of response and analyses of the disease state itself (n = 31; 27.4 percent). Validation of the study primary end point was rare (n = 5; 4.4 percent). Only one proposal’s research had been published to date.
About the Duke Clinical Research Institute
The DCRI is the largest academic research organization in the world, with a mission to develop and share knowledge that improves the care of patients through innovative clinical research. The DCRI conducts groundbreaking multinational clinical trials, manages major national patient registries, and performs landmark outcomes research. DCRI research spans multiple disciplines, from pediatrics to geriatrics, primary care to subspecialty medicine, and genomics to proteomics. The DCRI also is home to the Duke Databank for Cardiovascular Diseases, the largest and oldest institutional cardiovascular database in the world, which continues to inform clinical decision-making 40 years after its founding.