Data Sharing, Year 2 — Access to Data from Industry-Sponsored Clinical Trials
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*Marc Buyse, IDDI Inc. 

Keywords: data sharing

Since May 2013, investigators have been able to request access to de-identified individual patient data from clinical trials sponsored by GlaxoSmithKline, subject to review and oversight by an independent review panel. The first year of experience with this data sharing initiative was reviewed recently (1). A wide variety of research projects were granted access to patient level data. The 36 projects approved could be broadly categorized as follows: • studies aimed at comparing treatment regimens (n=3; e.g. to perform a meta-analysis of studies of epilepsy treatments) • studies aimed at optimizing treatments (n=3; e.g. to calibrate activated clotting time to avoid bleeding complications) • studies for patient stratification (n=3; e.g. to assess differential effects across ethnic groups) • studies of risk factors or biomarkers (n=6; e.g. to assess the effect of tumor size on survival) • methodologic studies (n=5; e.g. to develop predictive toxicology tools) • miscellaneous other studies (n=1 each; e.g. to study the relationship between influenza vaccination and lifestyle factors; to estimate the effectiveness of paroxetine in treating depression in adolescents; to elucidate the expected frequency of severe adverse events before designing a new trial to be conducted in the developing world, etc.)

In this talk I will provide updated information on the data sharing initiative, which has now been joined by several pharmaceutical companies. I will also discuss how this initiative could be extended and improved for maximum benefit to future research and patients.

1. Strom BL, Buyse M, Hughes J, Koppers BM. Data sharing, year 1 – Access to data from industry-sponsored clinical trials. N Engl J Med 371: 2052-4, 2014.