We commit to share patient-level data, trial-level data, CSRs, and protocols with qualified scientific researchers. Biogen has established a process for researchers to request access to such data from Biogen-sponsored interventional clinical trials conducted in patients (phase I-IV) for products and indications submitted to 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/Sharing Agreement signed by the data requestor. 

The research proposal may include enquiries for clinical trials outside of the scope of this policy. In these instances, Biogen will assess feasibility of sharing the data as part of the review process.

Exceptions to Biogen's data sharing policy:

Clinical trials where there is a reasonable likelihood that the participant could be re-identified, such as with trials of rare diseases and single-center trials

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

We generally do not 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. For information on the process for submitting a scientific or medical research proposal that includes a request for access to data from Biogen-sponsored clinical research, please visit Vivli. For general enquiries, please contact [email protected].

Biogen is committed to implementation of the PhRMA/EFPIA Principles for Responsible Clinical Trial Data Sharing and has established policies and processes to implement these Principles, as of 01 January 2014. The Principles reflect the biopharmaceutical sector's strong support for responsible data sharing that recognizes the importance of protecting patient privacy, respects the integrity of national regulatory systems, and maintains incentives for continued investment in biopharmaceutical research.

Under the Principles, Biogen, as a PhRMA and EFPIA member company, commits to enhance data sharing with qualified researchers, work with regulators to develop standards for sharing results with the patients who participate in clinical trials, enhance public access to clinical trial information, and reaffirm our commitment to publish clinical trial results.