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	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 requested hypothesis to be tested and the rationale for the proposed research ethical research plan sound statistical plan publication and posting plan qualifications and experience of requestor or intended researcher(s) (a statistician with a degree in statistics or a related discipline should be part of the research team) real or potential conflicts of interest source of any research funding whether the Informed Consents prohibit the proposed research if the proposal has potential to produce information that will enable identification of individual research participants.
Data Request Review Process	Biogen reviews all data requests internally based on the review criteria and in accordance with our Clinical Trial Transparency and Data Sharing Policy. Data requests that are denied due to the research proposal’s lack of clear scientific merit are also reviewed by 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	Anonymisation 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	http://clinicalresearch.biogen.com/

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