Data Sharing One Year Later

This month, the New England Journal of Medicine published the results of data sharing from pharmaceutical companies to researchers. Specifically, the authors, who are members the independent review panel for clinicalstudydatarequest.com, shared their experiences with this data sharing initiative after one year.

Clinicalstudydatarequest.com went live for GSK-only May 7, 2013, then multi-sponsor involvement began January 2014. The article reviews the May 7, 2013 to May 31, 2014 time frame and shows a total of 36 approved research proposals by the panel. Other highlights from the panel include the following:

• Requests were made for 97 GlaxoSmithKline studies that were not included in the system, of these 74 were approved.

• Study requests ranged from risk factors or biomarkers; methodologic studies; comparing treatment regimens; optimizing treatments; patient-stratification efforts; and miscellaneous other studies, including one proposal to evaluate the relationships between influenza vaccination and lifestyle factors.

As the members explained in the article, their purpose was to accept or reject proposals on the basis of scientific rationale and relevance to medical science or patient care. Other considerations the panel made were to the qualifications of the investigators, the existence and management of any potential conflicts of interest, and the clarity of a plain-English lay summary provided as part of the proposal. Recently, the system has incorporated a question “asking investigators who claim that they do not need approval from an ethics committee or institutional review board to specify why they deem such approval unnecessary.”

All in all, the independent panel members believe the first year was a success, and that the system will evolve over time.

For more information on data sharing and clinical trial data disclosure, please download our latest eBook on the topic, and visit our webpage devoted disclosure at www.appliedclinicaltrialsonline.com/disclosure.