Sharing Clinical Trial Information and Results
Sanofi believes that making clinical trial information available to the public benefits patients, healthcare providers and the scientific community.
As such, Sanofi publicly shares information on clinical trials based on our company commitments, international and local legal and regulatory requirements, and other clinical trial disclosure commitments established by the pharmaceutical industry associations.
Sanofi does, and will continue to evolve and expand its data-sharing commitment.
Public disclosure of results
For Sanofi-sponsored trials and studies, we disclose:
- Results of Phase 1 to 4 clinical trials conducted in patients, and as required in healthy subjects, in line with the respective regulatory requirements and/or company commitments, generally within 12 months of trial completion
- Results for trials of investigational products for which development has stopped are posted within one year of the discontinuation decision
- Trial results, including a description of the design and methodology, results of primary and/or secondary outcome measures and safety data, will be posted on a website accessible to the public free of charge, as follows:
- A written plain-language summary, i.e., ‘lay summary’, for trials started after July 2018, on triallaysummaries.com
- A set of tabulated results, i.e., mainly data tables, on clinicaltrials.gov and/or clinicaltrialsregister.eu
- A written summary from the clinical study report, on sanofi.com
- A publication reference or link to the journal article, for trials published in a peer-reviewed medical journal, on sanofi.com
- Results of non-interventional studies, also known as observational studies, are generally provided as a written summary or a publication reference, as listed above for trials
- In line with the 2010 International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Joint Position on the Publication of Clinical Trial Results in the Scientific Literature, results of our clinical trials through peer-reviewed journals, presentations at medical congresses, and other publicly available sources
Public disclosure of information on clinical trials and studies
For Sanofi-sponsored clinical trials and studies, we register information in an ongoing manner:
- Phase 1 to 4 clinical trials conducted in patients, and as required in healthy subjects, in line with the respective regulatory requirements and company commitments, generally within 21 days of first subject enrolment or earlier
- In a registry accessible to the public free of charge (ie, www.clinicaltrials.gov, www.clinicaltrialsregister.eu, encepp.eu, or alternatively a WHO primary/partner or other national registry)
- Non-interventional studies, also known as observational studies, are being registered with increasing frequency on one of the above sites, in line with the respective regulatory requirements and company commitments
- The registries contain enough basic information about each trial or study to inform subjects appropriately (and their healthcare practitioners), and to assist them in the enrolment process. According to the registry, information may include:
- Trial identification numbers (company study code, if available),
- National Clinical Trial (NCT) number, EudraCT number, Universal Trial Number (UTN), EU PAS Register number,
- 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.