Eli Lilly Allows Access To Clinical Trial Data

Eli Lilly announced in a press release that it will share data from its clinical trials with researchers around the world, joining Boehringer Ingelheim and Bayer, both of whom, in recent weeks, opened their clinical data to outsiders. Qualified researchers will be able to access Lilly’s clinical trial portal — a website that contains data from several clinical trial sponsors. The website is staffed by an independent scientific review panel, and Lilly will not be involved in approving research proposals. Approved researchers will only have access to a certain number of Lilly studies.

Tim Garnett, M.D., SVP and CMO of 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."

Lilly Clinical Trial Website

The multi-sponsor portal from which Lilly will share its data is called Clinical Study Data Request. Upon navigating the web browser to the site, the user will immediately see how to use the site and see the site’s sponsors, including Bayer, Boehringer Ingelheim, GSK, Lilly, Novartis, Roche, Sanofi, and ViiV Healthcare. Interested parties can learn how to submit a proposal and what the review process looks like. Additionally, researchers can view the studies listed before creating an account.

Lilly Clinical Programs

Lilly says that the portal includes certain Lilly-sponsored clinical programs, medicines, and indications in the U.S. and EU. The company states that data is anonymized for patient privacy. Lilly shared the programs available now.

• 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
• 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

Lilly shares other clinical data on its website. That site presents data on Phase 2, Phase 3, and Phase 4 clinical trials. Lilly intends to dismantle the site it opened in January 2014 (www.lillyclinicalstudydata.com) and replace it with the new multi-sponsor site mentioned above (www.clinicalstudydatarequest.com). Lilly says that it is committed to open access and transparency and the former site was an interim solution that is now solved with the new clinical trial sharing website.