|About||Biogen’s mission is to discover, develop and deliver innovative therapies that improve the lives of patients. We are grateful to the patients, healthy volunteers, families, hospitals and clinics that participate in the clinical trials for testing our potential therapies. Each individual’s participation contributes enormously to our understanding of disease and has the potential to benefit patients around the world.
Biogen is committed to supporting clinical trial disclosure and responsible data sharing in compliance with global legal and regulatory requirements and in alignment with the biopharmaceutical industry’s principles.
|Studies Listed for Sharing||Biogen-sponsored interventional clinical trials conducted in patients (phase I-IV) for products and indications submitted and approved, since 2004. Data will be provided to the researcher pending approval of a research proposal and a Data Use Agreement signed by the lead researcher and institution.|
|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 Biogen’s data package(s).|
|When Studies are available for sharing||Data from studies that meet the criteria are available 18 months after study completion. Biogen will routinely update the list of studies available.|
|Additional Conditions for Access|
|What information will be provided||We commit to share patient-level data, study-level data, CSRs, and protocols with qualified scientific researchers.|
|Questions or enquiries||DataSharing@biogen.com|
|Review Criteria for Data Requests||In determining whether a specific request for access to data and clinical trial information shall be granted, Biogen shall consider all relevant information, including:
|Data Request Review Process||Biogen reviews all data requests internally based on the criteria set forth in our Clinical Trial Transparency and Data Sharing Policy. Requests that are denied in whole or in part are then sent to an independent external review body, whose decision will be made transparent.|
|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.|
|Anonymization Standards||To be provided (in process).|
|Clinical Study Register or Website||http://clinicalresearch.biogen.com/|