Tim Garnett, M.D., senior vice president and chief medical officer, Eli Lilly, said, "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 differs from previous Lilly data-sharing sites in that access will be granted only after approval of a research proposal by an independent scientific review panel. Lilly will not be involved in the decisions made by the independent panel.
The multi-sponsor portal will include Lilly-sponsored interventional clinical studies from approved medicines and indications in the U.S. and E.U. in the following categories:
phase II, III or IV studies used as part of a regulatory approval submitted to the FDA on or after 1999;
phase II, III or IV global studies with a first patient visit after Jan. 1, 2007; and
phase II, III or IV global or regional/local studies in indications approved in both the U.S. and E.U. with a first patient visit after Jan. 1, 2014.
All shared data on the web site are anonymized to safeguard patients' privacy.
As part of Lilly's commitment to open access and transparency, the company established a web site in January to facilitate researchers' requests for data from interventional clinical trials for approved medicines and indications. However, this web site 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 with the newly announced site.
Lilly also provides information on and links to information about our clinical studies on www.lillytrials.com. The web site includes results of all Lilly-sponsored phase II, phase III and phase IV clinical trials, as well as observational trials of Lilly-marketed products conducted anywhere in the world that were initiated on or after Oct. 15, 2002.
