Trial results summaries for completed Biogen-sponsored clinical trials in patients are disclosed on local websites in compliance with international and national clinical trial disclosure requirements. In addition, we disclose trial results summaries for interventional trials conducted in patients (phase I-IV) completed after 01 Jan 2005, for approved products commercially available in at least one country, as well as for those products discontinued in development. Trial results are disclosed on this website using one or more of the following methods:

We further commit to publicly post CSR synopses on this website for products and indications submitted to and approved in both the United States and the European Union, after 01 January 2014.
CSR synopses will be redacted consistent with the need to protect privacy, publication rights, and confidential commercial information.
Result summaries are available within one year of the initial product approval or, for post-approval trials, within one year of trial completion. When a product in development has been discontinued, results of all interventional trials conducted in patients (phase I-IV) are disclosed on this website within one year of its discontinuation. We are also committed to sharing trial results summaries in a format that is easy to read and understand. These summaries, often referred to as plain or lay language results summaries, are posted publicly on this website for interventional trials conducted in patients (phase I - IV) or where required as per international disclosure requirements.

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:

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 datasharing@biogen.com.

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.