New England Journal of Medicine
August 1, 2013 Vol. 369 No. 5
Participant-Level Data and the New Frontier in Trial Transparency
Deborah A. Zarin, M.D.
N Engl J Med 2013; 369:468-469August 1, 2013DOI: 10.1056/NEJMe1307268
Medical progress is possible only because altruistic volunteers put themselves at risk in clinical trials. The results of those trials are then used to inform medical decisions. The traditional system of relying on investigators, sponsors, and journal editors to decide whether, when, and how to report trial results was based on trust. There was no way to know what trials had been conducted, what data were collected, how they were analyzed, and whether the reported data were complete and accurate. Policies mandating the registration of trials and the reporting of summary results were instituted to provide greater transparency. In turn…
Access to Patient-Level Data from GlaxoSmithKline Clinical Trials
Perry Nisen, M.D., Ph.D., and Frank Rockhold, Ph.D.
N Engl J Med 2013; 369:475-478August 1, 2013DOI: 10.1056/NEJMsr1302541
GlaxoSmithKline is providing access to patient-level clinical trial data under a new policy. This article reviews the data-access plan