Expanded access

Expanded access or compassionate use is the use of an unapproved drug or medical device under special forms of investigational new drug applications (IND) or IDE application, outside of a clinical trial, by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress.

Overview

The Food and Drug Administration (FDA) expanded access program, sometimes called "compassionate use," is designed to help patients who may benefit from treatments that are currently in development but have not yet been approved by the FDA. These patients usually have a disease for which no comparable or satisfactory therapy is available, and are unable to participate in ongoing clinical trials.

Types of Expanded Access

There are three types of expanded access which include individual patients, including for emergency use, intermediate-size patient populations, and larger populations under a treatment IND or treatment protocol.

Individual Patients

This includes access for one patient, usually in a non-emergency setting. Emergency use is a situation where a patient requires immediate access to a drug or device.

Intermediate-size Patient Populations

This includes access for more patients than for individual patient access, but fewer than for treatment access.

Larger Populations

This includes access for large numbers of patients who do not have other treatment options available. This is usually for a drug or device that is in the later stages of development.

Application Process

The application process for expanded access can be complex and time-consuming. It involves the submission of an application to the FDA, which includes detailed information about the patient's condition, the proposed treatment plan, and evidence that the patient cannot participate in a clinical trial.

Risks and Benefits

While expanded access can provide a lifeline to patients with no other treatment options, it also carries risks. These include the risk of side effects from the treatment, and the possibility that the treatment may not work. However, for many patients, the potential benefits outweigh these risks.

See Also

• Clinical trial
• Investigational New Drug
• Food and Drug Administration

Expanded access Resources
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