Making clinical trial data available to the research community advances science and medicine, builds knowledge, improves public health, and earns trust.
That’s why we’re committed to, and fully endorse, the PhRMA and EFPIA Principles for Responsible Sharing of Clinical Trial Data. It’s why we contribute data to large-scale studies that pool information from many sources: to deepen our understanding of diseases and shine a light on potential new targets for drugs and vaccines.
Enhancing our data-sharing with researchers
When it comes to sharing data with the external research community, we go beyond the PhRMA/EFPIA principles.
We’re proud participants in Vivli, a global clinical-research data-sharing platform. This multi-company portal allows researchers to request relevant data, whether it’s from a Sanofi company or another organization. Requests for patient-level data and clinical study reports from Sanofi-sponsored trials are accepted subject to approval by an independent review panel.
Sanofi works with non-profit consortia and organizations such as TransCelerate, ARCAD, and the Gates Foundation, whose noncompetitive environments allow us and other pharmaceutical companies to share and integrate data from clinical trials for analyses that can improve clinical trial design, enhanced safety signal interpretation, and improve our understanding of diseases for the benefit of patients.
For Sanofi products approved since January 1, 2010
Data and study reports for completed and published Phase 2-4 clinical trials associated with these products or with terminated clinical development programs in the same timeframe (if excluded from further development) are available for request.
Many of these trials are proactively listed on the Vivli platform. Researchers are welcome to contact us for access to data from clinical trials not listed, in particular those for products approved or programs terminated prior to January 1, 2010. For more information, visit Vivli.
Respecting clinical trial participants
When sharing our data, we fully respect the rights and privacy of the individuals who participate in our clinical trials.
Any data we share with third-party researchers is anonymized according to applicable standards.
We do not share anonymized data when we believe that there is a reasonable likelihood that the individual could be re-identified, as might be the case for certain rare diseases.
Enhancing public access to our clinical study information
We make written summaries of all clinical-trial study reports publicly available if they were filed with EU and US regulators on or after January 1, 2014. Sharing this information after product approval and indication is consistent with the need to protect patient privacy, publication rights, and confidential commercial information through appropriate redaction.
Sharing clinical trial results with the people who participate
We believe everyone should have the opportunity to get an understanding of research. That’s why we provide accessible and easy-to-read summaries of clinical trial results, ie “lay” summaries for all phases of Sanofi-sponsored clinical trials that started after July 2018. We share these with the people who participated in the trial and the broader public through our portal.
Certifying our procedures for sharing clinical trial information
We publicly certify that we have established processes and procedures to implement the PhRMA and EFPIA Principles for Responsible Clinical Trial Data Sharing.*
Reaffirming our commitment to publish clinical trial results
We submit the results of Sanofi-sponsored clinical studies for publication, whatever the outcome of the study or product development cycle.
* We’ve also posted synopses for some trials dating back to 1994.