All interventional clinical studies in patients:

• Submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
• Where Servier or an affiliate are the Marketing Authorization Holders (MAH).

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

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 anonymized patient-level and study-level clinical trial data. Researchers should be engaged in rigorous and independent scientific research.

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 an anonymisation 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 to compromise 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 approves the request, the decision is final and  Servier sends the decision to an Independent Review Board (IRB) of external experts for information.

If Servier partially approves or declines the request, we send our decision to the IRB for review. The decision made by the IRB is final and binding for Servier.

Servier strives to communicate the decision and any conditions to the researcher within 3 months

Permanent Independent Review Board Members are:

• Stephen Senn, PhD, Head of Competence Centre for Methodology and Statistics at CRP-Santé, 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.

The responsibilities and decision-making process are described in the Independent Review Board Charter.

Board decisions 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.

Anonymized 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.
• Complete the planned analysis within 12 months.
• 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.