Clinical Trial Data Sharing Successful, Panel Finds

Members of the panel that oversees the Clinical Study Data Request system have reported in the New England Journal of Medicine (NEJM) that after one year, the system has been successful in contributing to increased transparency in the industry.

Brian L. Strom, chancellor of Rutgers Biomedical and Health Sciences, and Chair of the independent advisory committee that reviews access requests, told Rutgers Today that pharmaceutical companies have been criticized for keeping information secret, especially data on unsuccessful trials. He said that GlaxoSmithKline took the lead in using the Clinical Study Data Request system, however now 10 companies have made 1,200 studies available. He commented, “Data sharing is seen as a monumental change in culture for the pharmaceutical industry.”

Data Sharing – Year 1

Brian L. Strom, M.D., M.P.H., Marc Buyse, Sc.D., John Hughes, B.Sc., and Bartha M. Knoppers, Ph.D. published a paper in the NEJM relating their experience in the first year of the data sharing system. The paper is titled, “Data Sharing, Year 1 — Access to Data from Industry-Sponsored Clinical Trials.” They said that since May 2013, investigators have been able to access GlaxoSmithKline’s data from 200 trials spanning back as far as January 1, 2007. Currently, GlaxoSmithKline has approximately 950 studies listed. In January 2014, the system began enrolling other companies. Authors write, “As the members of this panel, we now have more than 12 months of experience with this initiative — and can report that it has been a productive and successful first step.”

Company Participation

Company participation is growing and they are including studies gradually over time. For instance, GlaxoSmithKline is now listing studies conducted over the past 15 years. A few pharmaceutical companies asked to be part of the review process, but Dr. Strom and colleagues declined, saying that the panel must remain independent to serve the best interests of the drug sponsors, researchers, and patients. Dr. Strom said that pharmaceutical firms have come to realize that data sharing is a public responsibility and that additional analyses will not only strengthen product credibility, but could provide researchers with additional uses for medical treatments.

Data Requests

Researchers seeking access to trials sponsored by Bayer, Boehringer Ingelheim, GSK, Lilly, Novartis, Roche, Sanofi, Takeda, UCB, and ViiV Healthcare may register on the site and submit a research proposal. In the first 12 months, the panel reviewed 59 proposals and approved 36, made public on the website. Proposals were sorted into categories.

• Studies of risk factors or biomarkers
• Methodologic studies, such as predictive models or risk models
• Studies to optimize treatments
• Patient-stratification
• Miscellaneous other studies