Our commitment

In alignment with global legal requirements, the Industry Trade Association Principles¹, and internal company policies, Biogen is committed to sharing information about our clinical research as follows:

We register all interventional trials conducted in patients (phase I–IV) initiated after 01 Jan 2005, prior to trial initiation on www.clinicaltrials.gov,  and comply with other international and national clinical trial disclosure requirements.

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:

• Posted publicly on a national website, such as www.clinicaltrials.gov and www.clinicaltrialsregister.eu, according to required timelines
• Published in a peer-reviewed journal or at a scientific meeting
• Posted publicly as a Clinical Study Report (CSR) Synopsis

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 submit the results of all phase 3 clinical trials, and any clinical trial results of significant medical importance, for publication in peer-reviewed journals or at scientific meetings.

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  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.

The summary below represents the research proposals we have received since the effective date (January 1, 2014) of the PhRMA/EFPIA Data Sharing Principles.

Reasons for denial

NOTE: TRIAL RESULTS ARE PROVIDED FOR INFORMATIONAL PURPOSES ONLY. THE TRIAL LISTED MAY INCLUDE APPROVED AND NON-APPROVED USES, FORMULATIONS OR TREATMENT REGIMENS. IT IS NOT INTENDED TO PROMOTE ANY PRODUCT OR INDICATION AND IS NOT INTENDED TO REPLACE THE ADVICE OF A HEALTH CARE PROFESSIONAL. THE RESULTS REPORTED IN ANY SINGLE CLINICAL TRIAL MAY NOT REFLECT THE OVERALL RESULTS OBTAINED ACROSS THE PRODUCT DEVELOPMENT. ONLY A PHYSICIAN CAN DETERMINE IF A SPECIFIC PRODUCT IS THE APPROPRIATE TREATMENT FOR A PARTICULAR PATIENT. IF YOU HAVE QUESTIONS, PLEASE CONSULT A HEALTH CARE PROFESSIONAL. BEFORE PRESCRIBING ANY PRODUCT, HEALTHCARE PROFESSIONALS SHOULD CONSULT PRESCRIBING INFORMATION FOR THE PRODUCT APPROVED IN THEIR COUNTRY.

¹ The Pharmaceutical Research and Manufacturers of America (PhRMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), and the Japanese Pharmaceutical Manufacturers Association (JPMA) Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases; the PhRMA, EFPIA, IFPMA, JPMA Joint Position on the Publication of Clinical Trial Results in the Scientific Literature; and the PhRMA, EFPIA Principles for Responsible Clinical Trial Data Sharing

Note: The above information was last updated on 17 July 2024.