New Essay Examines the First Year of Open Access to Clinical Trials

A new essay published Oct. 15 in the New England Journal of Medicine has shared early insight into the medical community’s progressive adoption of clinical trial transparency, testing the waters wherein physicians, researchers, even the general public have increased access to the industry’s raw data.

According to the essay’s lead author Brian Strom, MD, MPH, Rutgers Biomedical and Health Sciences, Newark, NJ, considerable interest exists in open access to clinical trial data, and evidence suggests that reanalysis of previously published data can often lead to conclusions about the types of patients who should receive a given treatment that differ from the conclusions drawn by the original investigators.

A new system to review de-identified patient-level data from clinical trials sponsored by GlaxoSmithKline was launched in May of 2013 with 200 initial clinical trials. Now growing to more than 1,200 studies from 10 companies, the system includes several categories of represented research, including studies of risk factors or biomarkers, studies comparing treatment regimens, studies aimed at optimizing treatments, patient-stratification efforts, and other miscellaneous investigations.

Strom el al. argue that the system is “pathbreaking in allowing access to individual patient-level, analyzable data from clinical trials sponsored by the pharmaceutical industry.” They add that the overall approach to access is already demonstrating significant strengths.

“The system described here will undoubtedly evolve considerably over time,” the authors conclude. “Management of the proposals is likely to be turned over to an independent organization, a development that should make it more appealing for other manufacturers to join and should enhance public confidence in the process. We hope that academic researchers will be adding their data to such systems in the future. Some of us believe that all clinical trial data should eventually be put into the public domain for unconditional, universal access, but we see the current initiative as an important, swiftly implemented, and successful first step. The number of data requests submitted in the first 12 months after the system was launched (58 requests) is a testament to the eagerness of the medical community to reap the benefits of data sharing.”

Keywords: Physicians, Public Sector, Biological Markers, Access to Information, Research Personnel, Drug Industry, Information Dissemination, Risk Factors, Research


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