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Biogen

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 in both the United States and the European Union, 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). Deidentified data and documents will be shared under agreements that further protect against participant reidentification and data are provided in a secure research environment further protecting participant privacy.
Exceptions
  • Clinical trials where there is a reasonable likelihood that the study participant could be re-identified, such as with trials of rare diseases and single-center studies.
  • Clinical trials where data sharing is prohibited by the informed consent; or where regulatory, legal, contractual, or other limitations exist.
  • Clinical trials where data/documents are not in English.
  • Clinical trials where there are ongoing regulatory activities or publication plans.

Biogen does not generally share imaging data (e.g. DICOM files of images from x-rays, ultrasounds, MRI scans, etc.) and we will only share genomic data with explicit consent.
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 Access will be declined if

  • There is a potential conflict of interest, or an actual or potential competitive risk
  • The data requested is unavailable, not collected, or is not appropriate for the research proposal
  • The research proposal’s aim is considered commercial or litigious
  • The research proposal lacks clear scientific merit
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
  • The research objective can be met with the collected study data
  • The Informed Consents do not prohibit the proposed research
  • The data is not subject to legal, regulatory or contractual limitations
  • There are no competing publication plans
  • Study data and documents are in English
  • The proposal does not have potential to produce information that will enable identification of individual research participants
  • There are no practical constraints to providing the data (for example, issues related to the format of the databases or excessive operational costs preparing the data)
  • The scientific rationale and relevance of the proposed research to medical science or patient care
  • The ability of the proposed research plan (design, methods and analysis) to meet the scientific objectives
  • The publication plan for the research
  • The plain English summary is clear with sufficient detail to be understood by a non-specialist
  • Real or potential conflicts of interest that may impact the planning, conduct or interpretation of the research and proposals to manage these conflicts of interest
  • The qualifications and experience of the research team to conduct the proposed research
Data Request Review Process 
  • Data requests are initially reviewed by Vivli and Biogen for completeness and other parameters (relating to scope and meeting sponsor policies) and are then reviewed by an Independent Review Panel
  • In certain circumstances, access to data may be declined by Biogen, for example, where there is a potential conflict of interest or an actual or potential competitive risk
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 Anonymization of the datasets is necessary to allow data to be shared ethically and legally, and to maximize their significant social, environmental, and economic value, whilst preserving confidentiality of the individuals who participated in studies conducted by Biogen.
We use quantitative risk methodology to prepare anonymized clinical data and documents, following best practices provided by organizations such as PHUSE and TransCelerate as well as regulatory bodies.
We discuss with requestors their requirements and expectations, and prioritize information relevant to the analysis plan, as much as the data situation allows, to maintain maximum data utility, whilst observing applicable privacy laws and regulations and safeguarding the privacy of our participants.
Clinical Study Register or Website https://www.biogentrialtransparency.com/
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