DISCLOSURE OF INFORMATION ABOUT ON-GOING CLINICAL TRIALS AND RESULTS
Sanofi understands that the general public have a legitimate interest in on-going clinical trials and want access to the results of completed clinical trials. We publicly disclose information on clinical study protocols and results and respond to related external public requests in line with:
- Company transparency commitment
- International and local legal, regulatory and ethical requirements
- Compliance with commitments established by the Pharmaceutical Industry Associations
Public disclosure of information on on-going clinical trials
For on-going clinical trials sponsored by Sanofi, our company is committed to disclosing:
- Phase I to IV clinical trials conducted in patients, and for some vaccines trials conducted in healthy subjects, in a registry accessible to the public free of charge (i.e. www.clinicaltrials.gov, www.clinicaltrialsregister.eu or alternatively WHO primary/partner or other national registry) according to applicable regulations and no later than 21 days after the first subject enrolment.
- The registry will contain enough basic information about each trial to inform subjects appropriately (and their healthcare practitioners), and to assist them in the enrolment process.
This includes:
- Trial identification numbers (company study code, if available), National Clinical Trial (NCT) number, European Clinical Trials Database (EudraCT) number, Universal Trial Number (UTN),
- Brief title and official title,
- Trial description and purpose (e.g. treatment, diagnosis, prevention),
- Outcome measures, intervention (e.g. drug, vaccine),
- Condition or disease,
- Key eligibility criteria (including age and gender),
- Trial recruitment status,
- Location of the trial and contact information.
Public disclosure of results
For Sanofi sponsored trials, disclosure is as follows:
- Results of Phase I to IV clinical trials conducted in patients, and for some trials testing vaccines in healthy subjects, will be published on a website accessible to the public free of charge (i.e.www.clinicaltrials.gov; www.clinicaltrialsregister.eu; or alternatively WHO primary/partner or other national registry) in line with the respective regulatory requirements.
- Additionally, results for investigational product(s) for which development has stopped will be posted within one year of discontinuation decision.
- Depending on the development stage of the product, the phase of the study and the location, study results, including a description of the design and methodology, results of primary and secondary outcome measures, and safety, will be published either as:
- Tabulated results
- Publication’s reference or link to the journal article, for trials published in a peer-reviewed medical journal
- Summaries of Clinical Study Report, in a format recommended by the ICH E3 guidance.
- Access to Sanofi Clinical Study Results
Our Data Sharing Commitments
Sanofi believes that making clinical trial data available to the research community promises to advance science and medicine, contributes to improvements in public health and improves 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 the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) developed and endorsed a set of Principles for Responsible Sharing of Clinical Trial Data