Clinical Study Data Request Registered Users, Please Login



Study sponsor: Sanofi
Studies listed Sanofi Companies* will make clinical trial data available for request:
  • For drugs and biologics:
    • phase II - IV trials in patients sponsored by a Sanofi Company
    • submitted to the US and EU regulatory agencies as part of the request for marketing authorization for new medicines or a new indication for an approved medicine;
    • approved by both agencies on or after January 1, 2014;
      • For new indications, only trials submitted in the application in support of the new indication
    • provided that the trial results have been published
  • For vaccines:
    • phase II-IV trials in healthy volunteers
    • submitted to the US or the EU regulatory agencies as part of the request for marketing authorization for new vaccines or a new indication for an approved vaccine;
    • approved on or after January 1, 2014;
      • For new indications, only trials submitted in the application in support of the new indication
    • provided that the trial results have been published

Sanofi is committed to sharing data in line with our commitment to the PhRMA / EFPIA principles. Requests for clinical trial data from co-developed products, approved after Jan 1, 2014 that are not listed on the portal, can be submitted via the “enquiry” process. All requests will be reviewed and a decision made on a case by case basis.

* Sanofi Companies include: Sanofi, Sanofi Pasteur, and Genzyme Corporation
Exceptions Sanofi will not share data in the following circumstances;
  • When there is a reasonable likelihood that the individual participants could be re-identified, for example, clinical trials in rare diseases or single-center trials;
  • Where the Company determines there is a reasonable likelihood that sharing data could otherwise violate privacy rights of individuals;
  • If clinical data were collected subject to legal, contractual or consent provisions that prohibit or limit transfer to third parties;
  • When Phase IV clinical trials were conducted for non-registration purposes or local affiliate trials;
  • When substantial practical constraints exist to providing data access;
  • Sanofi will not share data with a third party where the informed consent specifically does not allow us to do so.
When studies are listed Once the product meets the criteria in “Studies listed” and does not fall within any of the “Exceptions” above, trials will be available on the site
Additional conditions for data access
  • Sanofi will require that any use of these data by a third party must address a scientific question in the same disease area as the original trial;
  • Access to data from trials listed as available on the site is determined by the Independent Review Panel based on the scientific merit of the research proposal. In exceptional circumstances, access to data may be declined by the sponsor, for example, where there is a potential conflict of interest or an actual or potential competitive risk.
Datasets and documents provided The following anonymized patient level data and information will be considered for each clinical trial for which data access has been approved according to this policy.

Raw Dataset. This is the raw data collected for each patient in the clinical trial
Analysis-ready dataset. This is the dataset Sanofi used for analysis
Protocols with any amendments. This describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial
Annotated case report form. This is a blank case report form with descriptions of the data collected and how they are described in the dataset
Statistical Methods. This describes methods of analysis and procedures for data handling
Dataset specifications. This is the meta-data which describes the datasets, e.g., variable labels, variable descriptions, code lists, formats
Clinical Study Report. This is the report of efficacy and safety data from the trial. It forms the basis of submissions to regulatory authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Appendices which include patient level data are not included as these data are provided in the anonymized datasets. To protect research participants’ privacy, personally identifiable information will be redacted. Redactions to this document will also be made to protect the privacy of our trial personnel and participating organizations, and to protect Sanofi’s commercially confidential information, including intellectual property rights
Enquiries Researchers may enquire about the availability of data from Sanofi clinical trials that are not listed on the site by completing the online enquiry form.
Access to study documents without patient-level data Researchers can enquire about access to clinical trial documents such as the Clinical Study Report by completing the online enquiry form.
Review criteria for enquiries All enquiries will be reviewed and processed by Sanofi and evaluated to determine whether:
  • The trials are for approved medicines and;
  • The results of the trials have been published in a peer-reviewed journal and;
  • Sanofi has the right to provide the data. For example, Sanofi may not have the authority because the medicine has been out-licensed to another company; the data are the property of an academic organization; data from third party databases under license agreements which prevent Sanofi from providing access and;
  • Sanofi considers there is a reasonable likelihood that the individual participants could be re-identified, for example, clinical trials in rare diseases or single-center trials and;
  • The resources and time required for Sanofi to retrieve data and documents from repositories and archives, to de-identify and redact personally identifiable information, would be prohibitive. In some cases, particularly for older trials, the time / costs could be considerable and Sanofi may turn down requests on this basis and;
  • If Sanofi considers that there are any significant practical constraints to providing access to the data. For example, data is not in electronic format, size of the databases.
Anonymisation standards
Clinical study register http://en.sanofi.com/rd/clinical_trials/our_commitments/clinical_study_results.aspx