Eli Lilly and Company 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 and the European Federation of Pharmaceutical Industries and Associations, to increase access to and transparency of clinical trial results with researchers.

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 United States and European Union (EU) 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 January 1, 2007; and
• Phase II, III, or  IV global or regional/local studies in indications approved in both the US and EU with a first patient visit after January 1, 2014.

All shared data on the website are anonymized to safeguard patients’ privacy.

To increase 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,” said Lilly in a press statement. 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 its clinical studies on www.LillyTrials.com. The website 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 October 15, 2002.

Source: Eli Lilly