||Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Regeneron supports data transparency practices that advance science and medicine, protect participant privacy, and are in the best interest of individuals who use our medicines and providers who prescribe them.
|How we share on the Vivli Platform
||Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial using the Vivli Data Request Form. Regeneron will use the Vivli platform to share anonymized data with approved researchers.
|Studies available for sharing
||Regeneron is committed to sharing clinical trial data for approved medicines and indications with external medical experts and scientific researchers in the interest of advancing public health.
||Regeneron is unable to share clinical trial data if:
- the research proposal does not represent a novel analysis or conflicts with additional planned and/or ongoing analysis(es) by Regeneron
- the requestor has potential or actual conflicts of interests or affiliations that raise concern
- the data cannot be readily anonymized
- there is a reasonable likelihood that a patient could be re-identified
- the data is subject to legal, contractual or privacy limitations that prevent sharing
- there are substantial practical constraints to providing the data
|When Studies are Available for sharing
||Anonymized patient level data or aggregate study data will be considered for sharing when Regeneron has:
- ensured ability to protect participant privacy
- received marketing authorization from major health authorities (e.g., FDA, EMA, PMDA, etc.) for the product and indication and has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data
|Additional Conditions for Access
|What information will be provided
||Based on the individual request, Regeneron may provide qualified researchers with access to the following:
- Anonymized patient-level (STDM or ADaM) or aggregate-level datasets
- Clinical study protocol and amendments
- Statistical analysis plan
- Dataset specifications
- Case report forms
- Redacted clinical study reports
|Questions or enquiries
|Review Criteria for Data Requests
||Regeneron’s Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
|Data Request Review Process
||Regeneron evaluates all data sharing requests internally based on the established review criteria.
|Access to study documents without participant-level data
||Regeneron may provide access to clinical trial documents in absence of the accompanying participant-level data.
||Prior to sharing, clinical trial data is anonymized in accordance with applicable laws and regulations. Due to anonymization, datasets shared with researchers may look different from those submitted to health authorities and used for publication(s).
|Clinical Study Register or Website
||Regeneron registers company-sponsored interventional clinical trials evaluating safety and/or efficacy on clinical trial registries, such as ClinicalTrials.gov and the European Clinical Trials Database (EudraCT), in compliance with applicable laws and regulations.