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.
The pharmaceutical industry as a whole demonstrated its support for sharing of clinical data when in July 2013, the members of PhRMA and EFPIA developed and endorsed a set of Principles for Responsible Sharing of Clinical Trial Data.
They include five commitments:
1. Enhancing data sharing with researchers
Sanofi will make clinical trial data and full CSRs available from studies sponsored by a Sanofi Company except Sanofi Pasteur, submitted to the US and EU regulatory agencies and where the product will be approved by both agencies on or after January 1, 2014. We will also make available trial data and full CSRs from vaccine studies sponsored by Sanofi Pasteur, submitted either to the US or EU regulatory agencies and where the product will be approved by either agency on or after January 1, 2014. For all trials conducted by the Sanofi's Companies, the requested trials must also have been accepted for publication.
Sanofi is pleased to be participating in a multi-company portal for the requesting and sharing of our clinical trial data. We believe this will provide an efficient means of requesting data from a number of companies through a single portal. A link to the data sharing portal will be available on January 1, 2014.
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 will require that any use of these data by a third party must address a scientific question in the same disease as the original trial, unless the informed consent expressly allows broader use. Sanofi will ensure that all data being shared with third party researchers will be anonymized according to applicable standards. Finally, Sanofi will 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 will be 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 will be made public. Decisions will be 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 will make available all CSR synopses filed with EU and US regulators, or national competent authorities of EU Member States on or after January 1, 2014. These will be made publicly available on the Sanofi website within one month after approval of the product and indication, consistent with the need to protect patient privacy, publication rights, and confidential commercial information through appropriate redaction.
3. Sharing results with patients who participate in clinical trials
Industry is working with regulators to adopt mechanisms such that summary results, written in lay language, would be made available to patients for the trials in which they participated.
4. Certifying procedures for sharing clinical trial information
We will publically certify that we are adhering to the principles in their entirety.
5. Reaffirming commitments to publish clinical trial results
Sanofi will continue to submit for publication the results from clinical studies in patients sponsored by the company whatever the study or product development outcome.
EFPIA and PhRMA joint principles for responsible clinical trial data sharing
On July 24, 2013, EFPIA and PhRMA formally launched their Joint Principles for Responsible Clinical Trial Data Sharing to Benefit Patients.
This commitment to data sharing will enhance research and scientific knowledge, advance patient care and improve public health. Under the Principles, biopharmaceutical companies will dramatically increase the amount of information available to researchers, patients, and members of the public.