Our commitments

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• Disclosure of information on ongoing clinical trials and on trial results
• Clinical Trial Registry
• Clinical Trial Results Database

Disclosure of information on ongoing clinical trials and on trial results

Recognizing that public health authorities and patient support groups have a legitimate interest in gaining fuller and faster access to the results of clinical studies, global organisations representative of the pharmaceutical industry, the European Federation of Pharmaceutical Industries and Associations (EFPIA), the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the Japanese Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA), co-signed on January 6, 2005, a commitment to transparency regarding clinical studies sponsored by its members.

A member of EFPIA, the sanofi-aventis Group subscribes to this commitment: information on current clinical trials and the results of clinical studies will be available for consultation by the public through the use of clinical trial registries on the one hand, and databases of the results of clinical trials, on the other.

• Download the press release dated January 6, 2005

Clinical Trial Registry

Sanofi-aventis will comply with the following:

• All phase II to IV clinical trials, other than exploratory trials, will be recorded in a registry accessible to the public free of charge, within 21 days following enrolment of the first subject;
• The registry will contain basic information about each trial sufficient to inform interested subjects (and their healthcare practitioners) how to enroll in the trial. This would include, at a minimum: brief title, trial description in lay terminology, trial phase, trial type (e.g., interventional), trial status, trial purpose (e.g., treatment, diagnosis, prevention), intervention type (e.g., drug, vaccine), condition or disease, key eligibility criteria (including age and gender), the location of the trial location and contact information;
• Each trial will be registered under a unique identification number to ensure transparency of clinical trial results. The unique identifier will enable registry users to track the trial through multiple databases, including clinical trial results databases;
• Any trial initiated or ongoing as of July 1, 2005 and meeting the requirements of the associations’ commitment, will be registered.

Sanofi-aventis has decided to register its clinical trials on the following web site:

• www.clinicaltrials.gov

Clinical Trial Results Database

Sanofi-aventis is committed to complying with the following:

• The results of all phase II to IV clinical trials, other than exploratory trials, conducted on a drug that is approved for marketing and is commercially available in at least one country, will be published in a database accessible to the public free of charge;
• Trial Results of exploratory trials will also be published if they are deemed to have significant medical importance and may have an impact on a marketed product’s labelling;
• Trial results for an investigational product that has failed in development will, if possible, be published if they have significant medical importance;
• If trial results are published in a peer-reviewed medical journal, the database will contain a citation to or link to the journal article and/or a summary of the results in a standard format, such as the ICH E-3 summary format, that includes a description of the trial design and methodology, results of primary and secondary outcome measures, and safety results.
  Study results will be recorded in a database in the ICH E-3 format if they are not published in a medical journal within required time frame.
• Results will include the unique identification number used to register the corresponding trial;
• As a general rule, results will be published within one year after the drug is first approved and commercially available in any country. For trials completed after this initial approval, publication will take place within one year of trial completion, unless such publication would compromise publication in a peer-reviewed medical journal or contravene national laws or regulations;
• Results of all ongoing trials or those completed after January 6, 2005 will be registered.

Sanofi-aventis has decided to publish the results of its clinical trials on the following web site:

• www.clinicalstudyresults.org