All interventional clinical studies in patients used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014:

• in the United States (US) or the European Economic Area (EEA)
• where Servier (Les Laboratoires Servier or an affiliate company) is the Marketing Authorisation Holder (MAH).

The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

In addition, Servier’s data sharing policy includes all interventional clinical studies in patients :

• sponsored by Servier
• with a first patient enrolled as of 1 January 2004 onwards
• for New Chemical Entity or New Biological Entity for which development has been terminated before any MA approval.

Any data sharing request out of the scope defined above, will be reviewed on an individual basis and data provided if materially possible(it may not be possible to provide data from old studies).For products developed with partners, data sharing may vary according to the agreement with the partner company.

Qualified scientific and medical researchers can request access to de-identified patient-level and study-level clinical trial data. Researchers should be engaged in rigorous and independent scientific research. Data will not be released to researchers with significant conflicts of interest, including individuals requesting access for commercial/competitive or legal purposes.

Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports(CSRs).

Access to patient-level data will depend on a number of constraints, such as the year the study was performed (an up-to-date format of data or documents) and a de-identification procedure not to jeopardize the protection of personal data.

Researchers should register on this Data Portal and fill in the research proposal form. This form in four parts should be fully documented.

The Research Proposal Form will not be reviewed until all mandatory fields are completed.

The four parts are:

• Part 1: Research Study Proposal Plan (Topic category, Objectives and Scope of the Research, etc.).
• Part 2: Research Team Description (Research site, professional qualifications, etc.).
• Part 3: Load Specification Manual (Data Base, Data Management tools, Statistical Analysis Plan, etc.).
• Part 4: Other information.

Participants in every Servier clinical trial have given informed consent for use of their clinical and demographic details within the context of that particular trial.

Therefore, your request must necessarily study the agent or the disease that was the subject of the original trial.

Researchers should be aware that there may be circumstances that prevent the sharing of patient-level data, notably in cases where the anonymity of the patients cannot be guaranteed, single-center studies, or clinical studies with a small number of patients.

One example is data from studies performed on rare diseases in which patients may be identified. Servier will not share case narratives, documents for adjudication, imaging data such as magnetic resonance imaging (MRI) scans, genetic data, exploratory biomarkers, or other information that Servier considers compromising the anonymity of patients.

A qualified panel of Servier experts who are familiar with the data in question will review all complete research proposals. The Servier team will ensure that the proposal is complete and consistent with the informed consent provided by the patient on entry to the study.

Servier will conduct the initial review, including scientific qualification of the researcher, the robustness and scientific merit of the research proposal, the ability of the requested data to answer the research question, and the technical feasibility.

Based on this assessment, Servier may fully approve, partially approve or decline the request.

If Servier fully approves the request, the decision is final. The research proposal will be transmitted to an Independent Review Board (IRB) of external experts for information.

If Servier partially approves or declines the request, Servier will send the research proposal to the IRB for review and recommendation based on the scientific qualification of the researcher, robustness and scientific merit of the research proposal. Members of the board should provide their best scientific advice on the research proposal and may assist Servier to take the final decision.

Servier will strive to communicate the decision and any conditions to the researcher within 3 months.

Permanent Independent Review Board Members are:

• Stephen Senn, PhD, statistics & methodology consultant, Luxembourg
• Cyrus Cooper, Professor of Rheumatology, Director of the MRC Lifecourse Epidemiology Unit, University of Southampton, UK

Additional external and independent clinical experts in their specific therapeutic area may be involved depending on the clinical field related to the request.

Their responsibilities are described in the Independent Review Board Charter

Board’s recommendation will be based on scientific considerations such as :

• Is the proposed research question clearly defined with a scientifically valid rationale?
• Will the requested data be a relevant source to actually answer the researcher’s (or research team’s) question?
• Is there a well-documented and rigorous Statistical Analysis Plan?
• Is there a plan to publish findings in a peer-reviewed journal or scientific meeting?
• Does the researcher (or the research team) have sufficient qualifications and expertise to conduct the proposed research?
• Is the researcher (or the research team) willing to declare all professional interests, affiliations, possible conflicts of interest and the source of any research funding?
• Is there a potential competitive use of the data?

You will sign a Data Sharing Agreement with Servier before access to data is given.

De-identified patient clinical trial data will be made available according to terms laid out in the Data Sharing Agreement

If the request is approved and before the transfer of data, a so-called Data Sharing Agreement will have to be signed with Servier, including requirements for the research team to:

• Only use the data for the agreed research purpose.
• Protect the privacy and confidentiality of clinical trial participants.
• Post a summary of the planned Analysis on a publicly-available primary register prior to the transfer of Servier’s data.
• Complete the planned analysis within 12 months.
• Publish a summary of results of the Analysis within 12 months and seek for publication in a peer-reviewed journal within 18 months after completing the Analysis
• Not share these Servier data in any way, including for formatting, with anyone else outside of the research team identified in the proposal.
• Agree to destroy all data and supporting documentation at the end of the research project and to provide written confirmation of destruction.

By signing the Data Sharing Agreement, the researcher undertakes not to attempt to identify subjects or to combine accessed data with other data that would lead to identification of subjects. The Data Sharing Agreement cannot be amended by the researcher.

The metrics below outline data sharing activites as of September 2017.
The metrics will be updated every year (last update November 2019)