Clinical Research Glossary

expanded access expanded access


A process for a doctor to request an unapproved treatment for a seriously ill patient.

Example of expanded access in a sentence

Doctors can seek approval to use a study treatment outside of research via an Expanded Access application.

More Info

Expanded Access is a path for a patient with an immediately life-threatening or serious disease or condition to access an investigational medical product (like a drug, biologic, or medical device). Expanded Access can make treatment outside of clinical trials possible when no other treatments are available and there is no clinical trial for the patient to join.

Expanded Access is also called “compassionate use.” Expanded Access is a program for doctors to request treatments that are not yet approved for seriously ill patients. This request is made by a patient’s doctors using the Expanded Access application. The company that makes the experimental drug also has to approve the request.

Other info to think about when joining a study

The concept of “Expanded Access” may be discussed if you are seriously ill or have a life-threatening condition, and the available treatments do not work for you.

“Expanded Access” may also be discussed with you if there is no clinical trial for you to enroll in.

You can always discuss with your doctor if there is a new unapproved treatment that could be requested via expanded access. It is important to note that Expanded Access is for treatment; it is not considered research.

This is an icon for concepts in this glossary that have regulatory processes. The icon depicts a winding arrow with a questionnaire and pill icon representing a research study on one end, and a checkmark on a shield at the pointed end.
This graphic represents concepts that follow a regulatory review process.

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