|About||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.|
|How we share on the Vivli Platform||Available studies are listed and searchable on the Vivli Platform. Data requestors should use the Vivli Data request form to request Servier’ s data package(s). If approved, requesters will need to sign a Data Use Agreement and Servier will upload the anonymized data into the Vivli platform for use by researchers in the secure Vivli research environment.|
||Prior to sharing, clinical trial data is anonymized in accordance with data privacy laws, regulatory guidance and best practices provided by organizations like PHUSE or TransCelerate.
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.
Servier has adopted a quantitative risk-based anonymization approach to ensure the main objectives of the data sharing:
Whenever possible, the below steps are followed and described in an anonymization plan.
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
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.
|Studies Listed for Sharing||
|Exceptions||Servier will not share studies:
|Questions or enquiries||Researchers may enquire about the availability of data from Servier sponsored clinical trials that are not listed on the site before they submit a data request. Please use the Vivli Enquiry Form. All enquiries will be considered on a case-by-case basis.|
|When Studies are available for sharing||Studies are considered for listing as available 6 months after the studied medicine has been approved in both EU and US or in EU or US when submission is not planned in both regions.|
|Review Criteria for Data Requests||Servier will conduct a feasibility assessment for all enquiries received, based upon the criteria described below:
|Additional Conditions for Access||Participants in every Servier clinical trial have given informed consent for use their data to study the medicine or disease Servier were researching. Therefore, the request must necessarily study the agent or the disease that was the subject of the original trial.
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.
|Data Request Review Process||Researchers can request access to our listed studies by providing a research proposal with a commitment to publish their findings. Data requests are initially reviewed by Vivli and Servier for completeness and established review criteria. The research proposal is then reviewed by the Independent Review Panel.|
|What information will be provided||Analysis ready dataset: This is the dataset used for analysis.
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.
|Access to study documents without participant-level data||Access to the Clinical Protocol and Clinical Study Report may be provided without participant-level data, upon approval of the research proposal and execution of the Data Use Agreement.|
|Clinical Study Register or Website||https://clinicaltrials.servier.com/|