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Clinical trials: Our disclosure commitments
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
Access to Sanofi Clinical Study Results:
For completed Sanofi sponsored trials, we disclose:
- Results of Phase I to IV clinical trials conducted in patients, and of some trials testing vaccines in healthy subjects, on a website accessible to the public free of charge (i.e. www.clinicaltrials.gov , www.clinicaltrialsregister.eu, a national registry, or sanofi.com) in line with the respective regulatory requirements and company commitments.
- Additionally, results for studies of investigational product(s) for which development has stopped are posted within one year of the discontinuation decision on sanofi.com.
- Study results, including a description of the design and methodology, results of primary and secondary outcome measures, and safety, are disclosed either as:
- Tabulated results, ie, mainly data tables,
- A publication reference or link to the journal article, for trials published in a peer-reviewed medical journal,
- A written summary from the Clinical Study Report.
Public disclosure of information on clinical trials
For Sanofis sponsored clinical trials, we disclose in an ongoing manner:
- 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, unless required earlier.
- 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.
- Trial identification numbers (company study code, if available),
- National Clinical Trial (NCT) number, 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.
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, Sanofi shares the results of our clinical trials through peer-reviewed journals, presentations at medical congresses, and other publically available sources
In 2017, Sanofi review their policy in order to provide more information on clinical trials, for example on healthy subject studies and results.