Compassionate use trial
Compassionate use trial
A Compassionate use trial (pronunciation: /kəmˈpæʃ.ən.ət juːs traɪəl/) is a provision in the field of medicine that allows the use of an unapproved drug or medical device for the treatment of a patient who has a serious or life-threatening condition and has no comparable or satisfactory alternative treatment options.
Etymology
The term "compassionate use" is derived from the concept of extending compassion to severely ill patients by allowing them access to potentially beneficial treatments that have not yet been fully approved by regulatory bodies such as the Food and Drug Administration (FDA).
Related Terms
- Expanded Access: A similar concept to compassionate use, expanded access refers to the use of an investigational drug outside of a clinical trial by patients who do not meet the enrollment criteria for the clinical trial.
- Emergency Use Authorization (EUA): A legal means for the FDA to approve new medical treatments or unapproved uses of approved medical treatments during a declared emergency.
- Investigational New Drug (IND): A drug that has been approved by the FDA for testing in humans but has not yet been approved for commercial marketing.
See Also
References
- FDA. (2018). Expanded Access. Retrieved from https://www.fda.gov/news-events/public-health-focus/expanded-access
- NIH. (2020). Understanding Expanded Access/Compassionate Use. Retrieved from https://www.nih.gov/health-information/nih-clinical-research-trials-you/understanding-expanded-access-compassionate-use
External links
- Medical encyclopedia article on Compassionate use trial
- Wikipedia's article - Compassionate use trial
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