Starting in January, Sanofi will expand access to information and data from clinical trials, sponsored by companies of the Sanofi group, in support of industry-wide efforts to promote a set of Principles for Responsible Sharing of Clinical Trial Data that the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) jointly released in July 2013.
“Sanofi has a history of contributing in this collective effort of sharing clinical trial data and results with researchers and patients with initiatives such as Project Data Sphere, an independent initiative of the Life Sciences Consortium of the CEO Roundtable on Cancer, the Coalition Against Major Diseases, and Prize4Life”, said Christopher A. Viehbacher, Sanofi CEO and currently serving as president of EFPIA. “Finding new therapies can be accelerated by fully sharing the successful and unsuccessful research results with other researchers. Data sharing helps to reduce duplication and allows researchers to build more effectively on the findings of other researchers. The private sector has taken a lead on this which I would hope academic researchers will follow.”
Sanofi will provide access to clinical trial data and related documents, including Clinical Study Reports (CSR), for studies sponsored by Sanofi companies that conduct clinical studies in humans. These studies must have been submitted to U.S. and EU regulatory agencies and the product must have been approved by both agencies on or after Jan. 1, 2014. For Sanofi Pasteur, requested studies must have been submitted either to the U.S. or EU regulatory agencies and the product must have been approved by either agency on or after Jan. 1, 2014.
Sanofi will continue to submit for publication the results from all company-sponsored clinical studies, regardless of the study outcome. In addition, the industry, including Sanofi, is working with regulators to adopt mechanisms so that clinical study sponsors will be able to provide lay language summary results directly to the individuals who participate.
To enable the process for requesting and gaining access to clinical trial data, Sanofi is participating in a multi-company portal for clinical trial data sharing (https://clinicalstudydatarequest.com).
Date: January 2, 2014