General Approach

1 – Data will be provided in the format utilized for analysis and stored within the sponsor company (e.g. SAS datasets).

2 – Data will be provided for single studies in accordance with Serviers data sharing policy.

Data anonymization

Servier has adopted a quantitative risk-based anonymization approach to ensure the main objectives of the data sharing:

• Reduction to an acceptably low risk of re-identification to protect study participants.
• Retaining data utility to allow external researcher to benefit from the data

Whenever possible, the below steps are followed and described in an anonymization plan.

• Identification of Identifiers (Direct and Quasi) through the Expert Determination Method
• Evaluation of the overall risk of re-identification (Deliberate re-identification attempt/ Inadvertent re-identification / Data Breach) and definition of a pre-defined threshold
• Proposal of anonymization methods for each of the identifiers

Replacement of the participants number by a new randomly assigned number. Correspondence table is deleted to ensure complete anonymization.

Removal of the Free text Variable (all comment fields, verbatim terms for adverse events, concomitant medications …)

Generalization in classes (age, country …)

Offset of the dates

• Definition of a set of analyses to be reproduced using anonymized data

Once anonymization is done, results of quantitative risk evaluation as well as results of reproduced analyses are summarized in an Anonymization Report to document both objectives protection of participant privacy & data utility.

• Completed Interventional clinical studies in patients sponsored by Servier submitted to the US and/or  EU  Regulatory  Authorities, for Marketing Authorization (MA) of new  medicines or new indications approved after 1st January 2014, where Servier or its affiliates is the Marketing Authorisation Holder (MAH).
• For products for which development has been terminated before any MA approval, data will be shared for interventional clinical trials in patients sponsored by Servier, with a first patient enrolled on or after 1st January 2004.

• Where data if subject to legal, regulatory, contractual, data protection limitations or consent provisions that prevent data sharing
• In case of potential conflicts of interest, or an actual or potential competitive risk
• If data cannot be readily anonymized or there is a reasonable likelihood that a patient could be re-identified (e.g., rare indication, monocentric studies, genetic/genomic data)
• When data requested are part of ongoing regulatory activities for data requested
• If the research proposal’s aim is commercial or litigious
• If there are substantial practical constraints to provide technical data access, for example there may be issues related to the size of databases or data from old studies
• Where data / documents requested are not in English, or not in a format that enable sharing
• Where the data requested is not appropriate for the research proposal and/or does not contain the data necessary to answer the scientific question proposed by the research
• In case of Servier products developed with partners, data sharing is dependent on the agreement between parties.

• Studies submitted to the US and/or EU Regulatory  Authorities, for Marketing Authorization (MA) of new  medicines or new indications , or studies for a product which development has been terminated.
• 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
• If privacy and confidentiality of research participants cannot be protected through anonymization, e.g. single site studies or studies in rare diseases.
• 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 Servier from providing access.
• Ongoing regulatory constraints
• Substantial practical/technical constraints to providing the data (e.g., X-Ray/MRI scan) or genetic/genomic data.
• Data labels and/or supporting documents are not in English
• Commercial or litigious purpose of the research
• The resources (costs) to retrieve data and documents from repositories and archives, anonymize data, and redact personally identifiable information from relevant documents. In some cases, the costs could be considerable and Servier may turn down requests on this basis.

Researchers should be engaged in rigorous and independent scientific research. Access to data may be declined by the sponsor, where there is a potential conflict of interest or an actual or potential competitive risk or when research’s aim is commercial or litigious.

For partnered compounds data access will be provided if the development partner agrees to data access and to related data sharing agreements with the requesting third party.

A condition of providing the data is that the external requester seeks publication of their research results. Servier is to be provided with a copy of the manuscript after journal submission for information. Servier may choose to provide the requester with comments on the document as a courtesy, but the external requester is not obliged to incorporate any feedback resulting from this review.

Research teams must include a biostatistician.

Protocols with any amendments. This describes the objectives, design, methodology, statistical considerations, and organization of a clinical study.

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.

Reporting and analysis plan/ Statistical Analysis Plan. This describes methods of analysis and procedures for data handling that were used for the clinical study report.

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 study. It forms the basis of submissions to regulatory authorities such as the 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 datasets provided.