Access to investigational therapies
- Types of access
- How to request access
There are several criteria that affect the decision to provide access to an investigational therapy.
Patients must meet the inclusion / exclusion (eligibility) criteria to be considered for participation. Biogen works with medical and scientific experts, as well as regulatory authorities from around the world, to develop the protocol for a clinical trial, which includes the eligibility criteria.
The principal investigator (study doctor) determines whether a patient meets the eligibility criteria.
Patients must be informed of potential risks and benefits of the investigational therapy. Patients who decide to participate must sign an Informed Consent Form.
Expanded Access Programs (EAPs) and Single Patient Access
Biogen will only consider requests for expanded access programs and single patient access when all of the following criteria are met.
There must be enough evidence that the investigational therapy would likely benefit the patient. Scientific data from clinical trials must show that the potential benefits to the patient from the investigational therapy are greater than the potential risks.
There must be an unmet medical need. The patient 1) must have a serious or life-threatening condition; 2) must have no appropriate treatment options as determined by a physician; and 3) must not be eligible and able to participate in a clinical trial of the investigational therapy.
Clinical development of the investigational therapy must not be affected. Because our goal is to help as many patients as possible, as quickly as possible, access to the investigational therapy outside of a clinical trial must not adversely impact or delay the clinical trials involving the investigational therapy. This is important because the data generated from clinical trials is used by regulatory authorities to determine whether the drug is safe and effective and can be approved for use.
The patient and / or caregiver must be informed of potential risks and benefits of the investigational therapy. The sharing of this information is an essential component of the informed consent process.
The physician must be responsible for his / her patient’s care. The patient’s physician must understand the risks and benefits of the investigational therapy, be prepared to follow all legal and regulatory authority requirements, and be willing to conduct all necessary medical monitoring, safety reporting and data collection.
Note: requests for expanded access programs (EAPs) and single patient access or emergency use will always be reviewed and decided on by Biogen based on these criteria.