Sanofi has committed to expanding access to information and data from clinical trials in support of industry-wide efforts to promote a set of Principles for Responsible Sharing of Clinical Trial Data jointly released by PhRMA and EFPIA this past summer.
Sanofi will make available clinical trial data and related documents, including Clinical Study Reports, for studies sponsored by Sanofi companies that conduct clinical studies in humans. These studies must have been submitted to U.S. and E.U. regulatory agencies and the product must have been approved by both agencies on or after January 1, 2014.
To enable the process for requesting and gaining access to clinical trial data, Sanofi, along with Boehringer Ingelheim, GSK, Roche, and ViiV Healthcare, is participating in a multi-company portal for clinical trial data sharing.