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Servier Clinical Trial Data Sharing
Servier will provide access to patient-level and study-level clinical trial data from interventional clinical trials submitted for medicines and new indications approved in the European Union or the United States of America after 1 January 2014, provided that the trials are not part of an ongoing review or a planned submission to a regulatory authority.
Every participant in every Servier clinical trial gives informed consent for use of their clinical and demographic details within the context of that particular trial. Therefore, further research 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 the cases where the anonymity of the patients cannot be guaranteed, single-center studies, or clinical studies with a very small number of patients. One example is data from studies performed in very 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 may compromise patient anonymisation. By signing the Data-Sharing Agreement, the researcher commits not to attempt to identify subjects or to combine accessed data with other data that would lead to identification of subjects.
Access to patient-level data will depend on a number of logistical constraints, notably the age of the study. Indeed, access to data on trials conducted many years ago may be limited by the obsolete or inadequate format of data or documents, including the anonymisation of personally identifiable information from the relevant documents.
For partnered products, data-sharing may vary according to the agreement with the partner company.
All valid research proposals will be reviewed by a qualified panel of Servier experts who are familiar with the data in question. 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.
All proposals will then be passed on to an Independent Review Board of external experts together with the report from the Servier panel where appropriate. Proposals approved by the Servier panel will be transmitted for information. The Independent Review Board will review all other applications in terms of scientific merit and value of the proposal, notably in terms of the definition of the research question and the statistical analysis plan. The Independent Review Board will make the final decision on the research proposal. Servier strives to communicate the decision and any conditions to the researcher within 2 months.
Once the research proposal has been approved, prior to providing access to data, the researcher will sign a Data-Sharing Agreement with Servier. Anonymized patient data will be made available according to terms laid out in the Data-Sharing Agreement.
Independent Review Board Members
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 experts 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.
How to submit a research proposal
If you are a qualified scientific or medical researcher and you are interested in submitting a research proposal to Servier and accessing clinical trial data, please click here and provide your name, research affiliation, email address, telephone number, and the completed Research Proposal Form.
To be received for consideration for access to anonymized patient-level or study-level data, all researcher requests must fulfill the following requirements:
- They must be submitted by qualified external medical and scientific researchers. The application for access should include the full name, affiliation, title, and address of the researcher, as well as details of the qualifications of the whole research team.
- They must be technically feasible.
- They must be accompanied by a valid and complete research proposal, which should clearly summarize the following information:
- the research objectives
- the therapeutic field
- the Servier product concerned and indication if appropriate
- the references of the clinical trials concerned
- the outcomes of interest
- the statistical analysis plan
- the data required
- the publication plan
- the source of funding
- the potential conflicts of interest
For any question related to clinical data-sharing, please contact us