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Regeneron

About 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.
Exceptions 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

For more information, visit: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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 or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • 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 Data will not be provided to construct an AI/ML model that will serve as the basis for a commercial product or is deemed high risk to Regeneron. Risk is assessed through a combination of factors such as the data requestor’s experience with Vivli, whether the requestor is from a commercial or academic entity, the aims of the research, competitive risk to Regeneron, and the type of data being shared (e.g., control vs. active arm).

Sharing of clinical trial data must comply with U.S. Department of Justice (DOJ) regulations governing access to US sensitive personal data and government-related data by countries of concern or covered persons, as set forth in 28 CFR Part 202.
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 ClinicalTrialTransparency@regeneron.com
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.
Anonymization Standards   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 Information System (CTIS), in compliance with applicable laws and regulations.
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