For patients & families
- For patients & families
- For investigators
- Transparency & data sharing
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, 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.
Deciding to participate in a clinical trial requires careful consideration. In most cases, the therapies investigated in clinical trials are not yet approved by regulatory agencies like the Food and Drug Administration (FDA) in the United States. The benefits and risks of taking the treatment are not completely known. By volunteering for a clinical trial, you are helping the medical community determine whether new treatments are safe and effective.
Current open trials
Biogen is conducting numerous clinical trials in neurologic, hematologic, and immunologic diseases to evaluate the efficacy and safety of potential therapies. Learn more about our currently enrolling trials by disease area here.
Our phase 3 trials for aducanumab are enrolling people in the early stages of Alzheimer’s diseaseTrial information
We are conducting a variety of studies to better understand our marketed and investigational MS treatmentsTrial information
With our collaborator Isis Pharmaceuticals, we are conducting late-stage clinical trials for this genetic diseaseTrial information
Access to investigational therapies outside of clinical trials
Patients may potentially gain access to an investigational therapy three ways: through clinical trials, expanded access programs (EAPs), and single patient access or emergency use.
We conduct clinical trials both to determine the safety and efficacy of investigational therapies and to better understand how to use our approved products. This includes exploring new ways of dosing or administering our medicines, or even testing them in a different disease.
Getting a new therapy to market can take 15 years or more, and only one out of approximately 10,000 identified potential therapies will ultimately be approved. For patients, this process can seem slow, but it is critical for ensuring that the therapy is safe and effective. The data gathered during our trials is also invaluable to the global healthcare community since it sheds new light on specific diseases and on human biology in general.
The approval of a new therapy requires years of research and development to ensure that a product is safe and effective. After a potential therapy has been thoroughly tested in a lab setting and deemed promising, it must pass through a strictly regulated approval process. This process spans three phases of clinical trials, or research studies, each with a different purpose and involving an increasing number of people.
Clinical trials follow strict, scientific standards that protect patients and help produce reliable trial results. Every clinical trial has a protocol, or study plan, that describes what will be done during the trial, how the trial will be conducted, and why each part of the trial is necessary.
BEGINNING THE PROCESS
Before a clinical trial on a potential therapy can start, Biogen submits an Investigational New Drug (IND) in the United States, or a Clinical Trial Application (CTA) as it’s called outside the U.S. to the local regulatory agency. We work with regulatory agencies around the world, including the Food and Drug Administration (FDA) in the U.S. and the European Medicines Agency (EMA) in Europe. The application describes the results of preclinical testing and clearly outlines the plan for conducting clinical trials.
Trials in Phase One emphasize safety and are usually conducted with healthy volunteers. The goal is to learn how the potential therapy is metabolized and to uncover its most frequent and serious side effects.
Trials in Phase Two gather preliminary data on how the potential therapy works for people with the target disease or condition. Some trials compare results for two different test groups: participants receiving the potential therapy and participants receiving a different treatment – either another drug or placebo. Researchers continue to pay close attention to safety and possible side effects.
In this final clinical phase, investigators gather more comprehensive information about a potential therapy’s safety and effectiveness. Trials might examine different patient populations, compare different dosage amounts of the potential therapy, or combine it with other treatments.
Once Phase Three is completed, the potential therapy can be filed with regulatory authorities like the FDA or EMA, which can then approve as a therapy for public use.
After a therapy has been approved, regulatory agencies often require additional studies. These post-marketing studies may evaluate the therapy on new patient populations, monitor the long-term impact or compare the therapy with other therapies.