Expanded access trial
Expanded Access Trial
Expanded Access Trial (pronounced: ex·pand·ed ac·cess tri·al) is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
Etymology
The term "Expanded Access" is derived from the concept of expanding the access to investigational drugs or treatments that are not yet approved by the Food and Drug Administration (FDA) or other regulatory bodies. The term "Trial" refers to the testing or trying out of these investigational treatments.
Related Terms
- Investigational New Drug (IND): An IND is a new pharmaceutical and biological drug candidate that has not yet been approved by the FDA or any other relevant regulatory authority for use in humans.
- Clinical Trial: A clinical trial is a research study performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device is safe and effective in people.
- Food and Drug Administration (FDA): The FDA is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
- Compassionate Use: Compassionate use is a treatment option that allows the use of an unapproved drug when no other treatments are available.
External links
- Medical encyclopedia article on Expanded access trial
- Wikipedia's article - Expanded access trial
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