Data sharing is an essential component of clinical research. We, at Servier, while protecting patient privacy are committed to make every effort to provide access to study protocol, patient-level and/or study-level clinical trial data, including clinical study report (CSR) to qualified scientific and medical researchers, in the best interest of patients and public health.
All interventional clinical studies in patients used for Marketing Authorization (MA) of medicines and new indications approved after 1st January 2014:
The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States is considered within this scope.
In addition, Servier’s data sharing policy includes all interventional clinical studies in patients :
Any data sharing request out of the scope defined above, is 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 depends on a number of constraints, such as the year the study was performed (an up-to-date format of data or documents) and an anonymization 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:
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, the 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 may 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 ensures that the proposal is complete and consistent with the informed consent provided by the patient on entry to the study.
Servier conducts 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 is transmitted to an Independent Review Board (IRB) of external experts for information.
If Servier partially approves or declines the request, Servier sends 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 strives to communicate the decision and any conditions to the researcher within 3 months.
Permanent Independent Review Board Members are:
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 and decision-making process are described in the Independent Review Board Charter
Board’s recommendation is based on scientific considerations such as :
You have to sign a Data Sharing Agreement with Servier before access to data is given.
De-identified patient clinical trial data is 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 is to be signed with Servier, including requirements for the research team to:
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. Please note that Servier does not anticipate negotiation on the DSA provisions and it is recommended that the researcher conduct an early review of the DSA provisions included in the template provided here, before the actual DSA is issued. Delays due to negotiation will delay data access