A clinical trial is a research study conducted to answer specific questions about new treatments, or to investigate new ways of using known treatments.
In most cases, the therapies and drugs investigated in clinical trials are not approved by Regulatory Agencies (such as the Food and Drug Administration (FDA) in the United States), and the benefits and risks of taking the treatment are not completely known. Clinical trials are used to determine whether new treatments are safe and effective. The clinical testing of experimental treatments or drugs is generally done in three phases, each successive phase involving a larger number of people. The knowledge gained from years of clinical trials regarding the safety and efficacy of new treatments or drugs ultimately may allow pharmaceutical companies to offer new and better options to patients.
At any time Biogen Idec is conducting numerous clinical trials in a variety of therapeutic areas. Information about clinical trials, such as the condition and intervention being studied, the phase, the study type and more is available at the US National Institutes of Health clinical trials website. To view those being conducted by Biogen Idec, click here.
IMPLEMENTATION OF PHRMA/EFPIA DATA SHARING PRINCIPLES
Biogen Idec is committed to implementation of the PhRMA/EFPIA Principles for Responsible Clinical Trial Data Sharing. Implementation of these Principles began 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 Idec, 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 study information, and reaffirm our commitment to publish clinical trial results.
To submit a scientific or medical research proposal that includes a request for access to participant-level data or Clinical Study Reports, please visit the WIRB Copernicus Group Data Request Center.
We are currently developing a portal for sharing synopses of Clinical Study Reports. Until the portal is launched, please contact email@example.com with any questions.
Investigator Initiated Trials
Biogen Idec supports investigator research through our Investigator Initiated Trial (IIT) program. All proposals are reviewed by a cross functional team of medical and scientific staff to confirm patient safety, operational feasibility, scientific merit, and alignment with Biogen Idec’s research goals.
Any individual or group interested in requesting Biogen Idec support of investigator sponsored research may submit a proposal via our web-based tool. Please click here to submit.