Monday, June 2, 2014

Lilly opens up clinical data access to researchers

Today, Lilly has announced that they're making their clinical data more available to scientific researchers. The webpage www.clinicalstudydatarequest.com is one step closer to making clinical trial data more accessible and transparent. Data is available from several clinical trials sponsors at this portal and the effort is made possible by Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA).  In order to gain access to the data, scientists will have to have research proposals approved by an independent scientific review
panel.

According to the Press Release at the Wall Street Journal, all patient data will remain anonymous and these are the research phases which will be available:

  • - 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.
What do you think about Eli Lilly's step towards transparency?  Should the clinical data be available to more people than just researchers?




No comments: