In support of ongoing efforts by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) to increase access to and transparency of clinical trial results with researchers, Eli Lilly and Company will begin sharing its clinical trial data with scientific researchers through www.clinicalstudydatarequest.com, a new website, which houses data from several clinical trial sponsors.
Differing from previous Lilly data-sharing sites, access to the new portal will only be granted after approval of a research proposal by an independent scientific review panel. Lilly will not be involved in the decisions made by the independent scientific review panel.
The portal will include Lilly-sponsored interventional clinical studies from approved medicines and indications in the U.S. and EU in the following categories: Phase II, III, or IV studies used as part of a regulatory approval submitted to the U.S. Food and Drug Administration (FDA) on or after 1999; Phase II, III, or IV global studies with a first patient visit after January 1, 2007; and Phase II, III, or IV global or regional/local studies in indications approved in both the U.S. and EU with a first patient visit after January 1, 2014.
"Scientific advancements to improve patient care require the collaboration and creative thinking of researchers around the world. Since our early partnership with academic researchers brought about the first commercial insulin, we've continued to seek new ways to bring our internal expertise together with the high-quality research being done beyond our walls," said Tim Garnett, M.D., senior vice president and chief medical officer, Eli Lilly and Company.
Earlier this year, Sanofi said it will abide by PhRMA and EFPIA principles for the sharing of clinical data by providing access to trial data and related documents, including clinical study reports, for studies sponsored by Sanofi companies that are conducted in humans.
Relatedly, GlaxoSmithKline said in October 2012 that the company would take steps toward advancing what he called its commitment to greater openness, transparency, and collaboration—three months after pleading guilty to U.S. Department of Justice charges of improper practices and agreeing to pay a $3 billion fine.