|About||The Galapagos mission is to develop transformational medicines in areas of high unmet need by combining internal with external science with the goal to add years of life and improve quality of life of patients across the globe.
At Galapagos, we believe that transparency of clinical study data promotes strong scientific research and advances science and medicine. Galapagos commits to ensure full compliance with all applicable laws and regulatory guidance and provides specific attention to the protection of personal data at study participant level.
|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 company’s data package(s). If approved, requesters will need to sign a Data Use Agreement and the anonymized data will be shared in the Vivli secure research environment.|
|Studies Listed for Sharing||Includes information about studies and where to find data (on Vivli and/or partner platform)|
|Exceptions||The request may be denied, including:
• Data anonymization is difficult due to e.g. a rare-disease therapeutic area or small sample size.
• The study was conducted in a region imposing restrictions due to privacy laws.
• The data requested is subject to legal, contractual or consent provisions which prohibit data transfer to a third party.
• If the request includes images (e.g. x-rays) , genetic data and/or exploratory biomarker data.
• Data will not be provided to requesters with potential or actual conflicts of interest, including individuals requesting access for commercial, competitive or legal purposes.
• The data request analysis overlaps or interferes with existing GLPG analyses/publication plans.
• The requested data can’t be properly converted to electronic format.
|When Studies are available for sharing||Studies are considered to be available:
After primary manuscript disclosing study primary endpoints, key secondary endpoints, and safety data is published.
And at earliest 6 months after the EMA and/or FDA approval with no further submission plans.
And after the primary manuscript has been published
The study last patient last visit must have occurred at least 18 months prior to the request.
|Additional Conditions for Access||Vivli will forward and approve the request if the following applies:
• The research team is required to sign a Data Sharing Agreement / Data Use Agreement.
|What information will be provided||• Protocol
• Annotated case report forms
• Anonymized SDTM/ADaM data
• Statistical analysis plan
• Data dictionary
• Anonymized/redacted CSR (synopsis)
|Questions or enquiries||Questions can be sent to GLPG by means of the Vivli Enquiry form.|
|Review Criteria for Data Requests||There is an in-depth statistical analysis plan.
In case of a request which includes multiple trials, there must be a clear plan to pool the data.
|Data Request Review Process||Consistent with expectations of good scientific practice, researchers can request access to our studies by providing a research proposal with a commitment to publish their findings. The research proposal is reviewed by an independent review panel. This is a team of external independent experts.|
|Anonymization Standards||Risk-based approach (both qualitative and quantitative) to minimise risk of patient re-identification, derived from the industry best practices from PhUSE, TransCelerate, and Regulatory Guidance from EMA and Health Canada. The overall aim is for a pragmatic balance, ensuring an acceptably low risk of re-identification whilst retaining data utility.|
|Clinical Study Register or Website||https://www.clinicaltrials-glpg.com/|