Ethics in clinical trials - Policy

Sanofi-aventis conducts clinical trials worldwide in compliance with the most stringent good clinical practices regulations.

Trials are monitored by the authorities and by ethics committees.

Subjects participating in the trials are fully informed and must give their consent.

Therapeutic trials and their results are posted on web sites that the public may consult free of charge.

Sanofi-aventis commits to disseminate all information concerning ongoing clinical trial protocols on the site of the U.S. National Institutes of Health (NIH), www.clinicaltrials.gov. All new trials are posted 21 days at most after enrollment of the first subject.
Since January 6, 2005, trial results, with the exception of exploratory studies, are published on the web site www.clinicalstudyresults.org. Sanofi-aventis also commits to publish results whether or not trial findings are positive. For commercialized products, the results are published during the year following completion or discontinuation of the trial.

Clinical trials, as well as the systems and processes they involve, are audited by the Quality and Compliance Department, which is independent from the Clinical and Preclinical Development Department. A very strict policy concerning respect and/or compliance with GCP is applied to immediately notify the relevant managers and regulatory authorities, as well as ethics committees, in the event of noncompliance with the principles.