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Sponsor Specific Details: Sanofi

  • Studies listed

    Sanofi believes that making clinical trial data available to the research community promises to advance science and medicine and contribute to improvements in public health. As such, Sanofi has a history of sharing data and expands this commitment to sharing clinical trial data via CSDR.

    Sanofi will list Interventional phase II - IV clinical studies that were included in the request for marketing authorization of new medicines and new indications for drugs, biologics, vaccines and devices.

    These will include studies for products approved on or after January 1, 2014 by both the US and EU Health Authorities, or by the US or EU Health Authorities when regulatory submissions in both regions are not planned.

    Studies will be listed when the primary study results have been accepted for publication.

  • Exceptions

    Sanofi will not share data when the following conditions apply:

    Sanofi believes that the privacy and confidentiality of research participants cannot be protected through anonymization, e.g. single site studies or genetic/genomic data.

    There are legal or contractual agreements in place that would limit our ability to share the data with a third party, such as when the medicine has been out-licensed to another company, the data are the property of another organization, data are from third party databases under license agreements which prevent Sanofi from providing access.

    There are substantial practical/technical constraints to providing the data. Examples include: data are not available in electronic format or data are images (e.g., X-Ray/MRI scan).

    When phase IV clinical trials were conducted for non registration purposes or by local affiliates.

    Clinical trials where data labels and/or supporting documents are not in English.

    For co-developed products approved after Jan 1, 2014 that are not listed on the portal, requests can be submitted via the “enquiry” process. All requests will be reviewed and a decision made on a case-by-case basis.

  • 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 listed on the site.

    Sanofi will regularly update this list to add trials meeting the criteria. An enquiry can be submitted for studies that are not yet listed.

  • Additional conditions for data access

    Prior to 2014, patients agreed to take part in Sanofi clinical trials and gave Sanofi permission (through informed consent) to use their data to study the medicine or disease being researched. Therefore, 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. For Sanofi trials initiated in 2014 and onward, patients have been asked to give permission for broader research beyond the original trial intent, so research on other disease areas may be possible with data from these trials.

    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

    Where available, the following anonymized patient level data and information is provided for each clinical trial:

    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.
  • 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. This is the only method for requesting access to Phase I trials, trials for terminated products, and trials for co-developed products. These requests will be considered on a case-by-case basis.

  • 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

    Sanofi will conduct a feasibility assessment on all enquiries received, based upon the criteria for inclusions and exceptions above. We will also accept requests for Phase I studies, terminated compounds and co-developed products.

    Please be aware that the feasibility assessment for older compounds/studies may require additional lead times due to legal and operational constraints.

  • Anonymisation standards
  • Clinical study register