GSK Opens Access to Data From More Than 200 Clinical Trials

Janis C. Kelly

July 31, 2013

The movement to increase the transparency of clinical trial data accelerated this week when GlaxoSmithKline (GSK) officials announced the company would provide access to deidentified patient-level data from GSK-sponsored clinical trials to research teams seeking to use those data to address specific scientific questions.

In a special report published in the August 1 issue of the New England Journal of Medicine, Perry Nisen, MD, PhD, senior vice president for science and innovation, and Frank Rockhold, PhD, senior vice president and head of global clinical safety and pharmacovigiliance at GlaxoSmithKline, described the data currently available, the criteria a research team must meet to gain access, and the process for obtaining access to the data.

Data availability can be determined by searching the GlaxoSmithKline Clinical Study Register. The initial tranche includes about 200 clinical studies (phases 1 - 4) conducted since January 1, 2007. The Web site will not include observational studies or clinical trials of medicines for which GSK does not have the legal authority to share data, such as those licensed to another company. Dr. Nisen and Dr. Rockhold note that the company anticipates adding studies going back to December 2000 and expects that about 400 studies will be on the Web site by the end of 2013.

Investigators will now be able to request access to deidentified patient-level data from some GSK-sponsored trials, but the authors emphasize that obtaining access will be dependent on meeting certain GSK criteria.

"It is important that the analyses proposed by investigators petitioning to access a data set have scientific credibility. We believe that there are public health risks if the proposed analyses are not scientifically robust and give rise to erroneous concerns about safety or false hopes of a potential benefit for patients. Therefore, in accordance with the expectations of usual good scientific practice, investigators will be required to submit a brief research proposal with the use of an online form (Section 2 in the Supplementary Appendix), describing their analysis and publication plans, their management of potential conflicts of interest, and the qualifications and experience of the research team (which should include a statistician)," the authors write.

In an accompanying editorial, Deborah A. Zarin, MD, director of ClinicalTrials.gov and assistant director for clinical research projects at the National Library of Medicine Lister Hill National Center for Biomedical Communications, Bethesda, Maryland, contrasted the GSK controlled-access approach with the open public-access approach to participant-level data noted in an article by investigators from the National Institute of Allergy and Infectious Diseases Immune Tolerance Network, appearing in the same issue of the journals.

"The GSK and ITN data policies are bold attempts to modify and improve the process by which research is reported. We have to learn as much as we can from these experiments about the benefits, risks, costs, and appropriate role of disclosing participant-level data, in service to the ultimate goal of honoring each trial volunteer's altruism," Dr. Zarin said.

Dr. Nisen and Dr. Rockhold are employees of GSK. Dr. Zarin has disclosed no relevant financial relationships.

N Engl J Med. 2013;369:468-469, 475-478.

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