Sanofi believes that making clinical trial data available to the research community promises to advance science and medicine, contribute to improvements in public health and improve knowledge about and trust in pharmaceutical drug development.
The concept of sharing data for research purposes is not new for Sanofi. Our company has a history of contributing to initiatives where data sets are pooled for research purposes.
Consistent with this history, Sanofi committed in July 2014 to extend its data sharing activities and endorsed the PhRMA and EFPIA Principles for Responsible Sharing of Clinical Trial Data.
They include five commitments:
1. Enhancing data sharing with researchers
Sanofi’s commitment to share data with the research community goes beyond the EFPIA and PhRMA Principles.
For Phase 2-4 clinical trials sponsored by a Sanofi Company, Sanofi makes patient level data and full CSRs available for request for a product that has been approved on or after January 1, 2010 by both the US and EU Health Authorities, or by the US or EU Health Authorities when regulatory submission for the product is not planned in both regions. We also make Phase 2-4 clinical trial patient level data and full CSRs available for request for programs that have been terminated on or after January 1, 2010 and formally confirmed as excluded from any further internal or external development activities. For all the Sanofi Companies, eligible trials must be completed and the primary trial results accepted for publication.
In addition, Sanofi accepts requests for clinical trial patient level data and full CSRs from other trials (e.g. Phase I studies, observational studies and studies from products that have been approved by the US and EU Health Authorities or have been terminated prior to January 1, 2010).
Sanofi is pleased to be participating in the multi-company portal www.Vivli.org for the requesting and sharing of our clinical trial data. We believe this portal provides an efficient means for researchers to request data from studies sponsored by a Sanofi Company and other companies through a single portal.
Participants in Sanofi-sponsored trials gave their consent for the use of their data in the context of a particular trial. To this end, Sanofi will not share data with a third party where the informed consent specifically does not allow us to do so. Sanofi requires that any use of these data by a third party addresses a scientific question in the same disease as the original trial, unless the informed consent expressly allows broader use. Sanofi ensures that all data being shared with third party researchers are anonymized according to applicable standards. Finally, Sanofi does not share anonymized data when we believe that there is a reasonable likelihood that the individual could be re-identified, for example, for certain rare diseases.
Requests for data are reviewed by an Independent Review Panel (IRP), comprised of publicly named scientists and healthcare professionals who are not employees of the company. The membership of this panel has been made public. Decisions are based upon criteria which are aimed at ensuring that the proposal has scientific merit – that is, it has the potential to advance medical knowledge and contribute to the advancement of public health. The proposed research must be feasible and the research team must be suitably qualified to conduct the research.
2. Enhancing public access to clinical study information
Sanofi makes available all CSR synopses, ie written summaries filed with EU and US regulators, on or after January 1, 2014. These are made publicly available from the Sanofi disclosure commitments page after approval of the product and indication, consistent with the need to protect patient privacy, publication rights, and confidential commercial information through appropriate redaction. In addition, since 2005, Sanofi has posted individual CSR synopses for trials dating back to 1994.
3. Sharing results with patients who participate in clinical trials
A lay summary is a short document summarizing the results of a clinical trial in a format understandable by a general audience (laypersons). Under Sanofi commitments, lay summaries are prepared for phase 1 to 4 Sanofi-sponsored trials that started in or after July 2018. The summaries are shared with trial participants and the general public after the end of the trial, at Triallaysummaries.com.
4. Certifying 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.
5. Reaffirming commitments to publish clinical trial results
Sanofi continues to submit for publication the results from clinical studies in patients sponsored by the company whatever the study or product development outcome.