BioCentury
ARTICLE | Politics & Policy

GSK provides update on data requests

August 1, 2013 1:19 AM UTC

A spokesperson for GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said the pharma has received five requests for data related to 40 trials since the pharma launched a website in early May through which researchers can request patient-level data. The spokesperson said a few requests are close to being approved but declined to disclose a timeline for approval or a breakdown of how many requests have been for whole program data, patient-level data or aspects of a single trial. GSK in October committed to release anonymized patient-level data to researchers pursuing a "valid scientific endeavor." The pharma is also making publicly available clinical trial reports (see BioCentury Extra, Oct. 11, 2012).

An independent panel of experts reviews each data request for scientific merit. Perry Nisen, SVP of science and innovation at GSK, said a vetting process was a necessary safeguard for the company's data access scheme to prevent erroneous results due to poor or flawed analyses (see BioCentury This Week, April 14). ...