|Sanofi is a global health company that is committed to sharing clinical study data with external researchers, as articulated in the Pharmaceutical Research and Manufacturers of America (PhRMA) / European Federation of Pharmaceutical Industries and Associations (EFPIA) Principles for Responsible Clinical Trial Data Sharing.
|How we share on the Vivli Platform
|Studies available for sharing are listed and searchable on the Vivli Platform. Data requestors should use the Vivli Data request form to request Sanofi data package(s). If approved, requesters will need to sign a Data Use Agreement and the anonymized data will be shared in the Vivli secure research environment.
Data from clinical studies for co-developed products approved on or after Jan 1, 2010, and from clinical studies for products which development has been terminated on or after January 1, 2010 that are not listed on the portal can be requested by completing the Vivli Enquiry Form as described below. These requests will be reviewed and a decision made on a case-by-case basis.
|The following data protection procedures for personally identifiable and quasi-identifiable information are performed by Sanofi prior to data sharing:
- Study Participant ID: Replaced with a new random study participant ID that cannot be linked back to the original study participant.
- Site ID: Replaced with a new random site number that cannot be linked back to the original site ID, however, can be still used to link information within anonymized study dataset.
- Investigator ID: Removed.
- Dates: Replaced by study days relative to a “baseline/ reference date”.
- Date of birth: Only AGE is kept and converted into classes.
- Date of death: Removed; relative day of death is converted to relative WEEK of death.
- Geographic information: Grouping of countries until all combinations of GENDER * RACE * GROUPED_COUNTRY are >= 3 study participants.
- Demographic Information: Ethnicity is removed. Races aggregated with few study participants under “Other” race group until all combinations of GENDER * RACE * GROUPED_COUNTRY are >= 3 study participants.
- BMI, weight and height: Classified and/or removed.
- Free Text, Verbatim, Comments: Removed
Specifications for anonymization may vary depending on a per study basis and are subject to adjustment according to guidance from e.g. Phuse and TransCelerate methodology.
More information about the anonymization of data prior to sharing can be found in the Sanofi Anonymization Standards.
|Studies Listed for Sharing
|Data from interventional phase II – IV clinical studies will be made available for request
- for products that have been approved on or after January 1, 2010, by both the US and EU Health Authorities, or by the US or EU Health Authorities when regulatory submissions are not planned in both regions;
- for products which development has been terminated on or after January 1, 2010 (i.e. formally confirmed as excluded from any further internal or external development activities).
Within the product scope defined above, a clinical trial (interventional study) will be listed as available for request through the portal when the trial meets the following criteria:
- the trial has been completed (or terminated after patients were enrolled);
- and the primary trial results have been accepted for publication and in exceptional circumstances assessed by study sponsor, only after key secondary results have been accepted for publication;
- or, in the absence of a publication, when the trial results have been made publicly available.
|Sanofi will not list studies when one of the following conditions applies:
- Sanofi believes that the privacy and confidentiality of research participants cannot be protected through anonymization, e.g. single site studies, or studies in rare diseases.
- There are legal or contractual agreements in place that would limit our ability to list the study and 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, the data originate from third party databases under license agreements which prevent Sanofi from providing access.
- There are ongoing regulatory or legal constraints on data sharing that would limit our ability to list the study. Requests for such studies will be considered on a case-by-case basis.
- There are substantial practical/technical constraints to providing anonymized data. Examples include: data are not available in electronic format or data are images (e.g., X-Ray/MRI scan) or genetic/genomic data.
- The data labels and/or supporting documents are not in English (e.g. local studies).
|When Studies are Available for Sharing
|Clinical trials will be eligible for listing once the above criteria in “Studies listed for sharing” are met and none of the “Exceptions” above apply.
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 Access
|Prior to 2014, when patients agreed to take part in Sanofi clinical trials they 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 clinical 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 study sponsor, for example, where there is a potential conflict of interest or an actual or potential competitive risk.
|What information will be provided
|Depending on availability, Sanofi can provide the following anonymized data and redacted supporting clinical documents:
- Raw dataset. This is the raw data collected for each patient in the clinical trial.
- Study Data Tabulated Model (SDTM) dataset. This is the dataset Sanofi used for submission.
- Analysis Data Model (ADAM) datasets. This is the dataset Sanofi used for analysis & submission.
- Protocols with any amendments. This describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial.
- Blank case report form. This is a blank case report form.
- 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.
- Anonymization report. This describes the method of anonymization.
- Clinical study report. This is the report of efficacy and safety data from the trial. It forms the basis of submissions to Health Authorities. Appendices which include patient level data are not included as these data are provided in the anonymized datasets.
|Questions or enquiries
|Researchers may enquire about the availability of data from Sanofi sponsored clinical trials that are not listed on the site before they submit a data request. Please use the Vivli Enquiry Form. All enquiries will be considered on a case-by-case basis.
|Review Criteria for Data Requests
|Sanofi will conduct a feasibility assessment for all requests received, based upon the criteria described below:
- The requested studies are for a product that has been approved by the Health Authorities, or for a product which development has been terminated.
- The studies are completed (or terminated after patients were enrolled) and the primary study results (and in exceptional circumstances key secondary results) have been accepted for publication, or, if a publication is not feasible, the results have been made publicly available.
- Sanofi believes that the privacy and confidentiality of research participants cannot be protected through anonymization, e.g. single site studies or studies in rare diseases.
- There are legal or contractual agreements in place that would limit our ability to list the study and/or 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, the data originate from third party databases under license agreements which prevent Sanofi from providing access.
- There are ongoing regulatory or legal constraints on data sharing that would limit our ability to list the study and/or share the data.
- 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) or genetic/genomic data.
- The data labels and/or supporting documents are not in English.
Please be aware that the feasibility assessment for older compounds/studies may require additional lead times due to legal and operational constraints.
|Data Request Review Process
|Researchers can request access to our listed studies by providing a research proposal with a commitment to publish their findings. Data requests are initially reviewed by Vivli and Sanofi for completeness and other parameters (relating to scope, system-compatibility, and meeting sponsor policies) and are then reviewed by a fully independent review panel. This is a team of external independent experts.
|Access to study documents without participant-level data
|Researchers can enquire about access to clinical study documents such as the Clinical Study Report by using the Vivli Enquiry Form.
|Clinical Study Register or Website