Lilly Announces Increased Access to Clinical Trials Data for Qualified Researchers
Eli Lilly and Company today announced it will begin sharing its clinical trial data with scientific researchers through www.clinicalstudydatarequest.com. This website, which houses data from several clinical trial sponsors, was created 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 around the world.
"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.
"By joining others in our industry to share clinical trial data with qualified researchers, we can quicken the pace of scientific advances needed to make life better." The new portal, www.clinicalstudydatarequest.com, differs from previous Lilly data-sharing sites in that access 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 multi-sponsor portal will include Lilly-sponsored interventional clinical studies from approved medicines and indications in the U.S. and EU in the following categories:
-- Phase 2, 3 or 4 studies used as part of a regulatory approval submitted to the U.S. Food and Drug Administration (FDA) on or after 1999;
-- Phase 2, 3 or 4 global studies with a first patient visit after January 1, 2007; and
-- Phase 2, 3 or 4 global or regional/local studies in indications approved in both the U.S. and EU with a first patient visit after January 1, 2014.
All shared data on the website are anonymized to safeguard patients' privacy.
Former Lilly Clinical Trial Websites to Be Replaced As part of Lilly's commitment to open access and transparency, the company established www.lillyclinicalstudydata.com in January 2014 to facilitate researchers' requests for data from interventional clinical trials for approved medicines and indications. However, this website was an interim solution as Lilly worked with others in the pharmaceutical industry to create coordinated access to data from multiple study sponsors. Now that this coordinated access is available, Lilly will replace the current web site, www.lillyclinicalstudydata.com, with the newly announced www.clinicalstudydatarequest.com.
Lilly also provides information on and links to information about our clinical studies on www.LillyTrials.com. The website includes results of all Lilly-sponsored Phase 2, Phase 3 and Phase 4 clinical trials as well as observational trials of Lilly-marketed products conducted anywhere in the world that were initiated on or after October 15, 2002.