Preferred Label : Compassionate Treatment;
NCIt related terms : Compassionate Use; Expanded access; compassionate use trial; pre-approval access; expanded access trial;
NCIt definition : Providing experimental therapies to very sick individuals even though they don't meet
the critera for inclusion in a trial.;
Alternative definition : NCI-GLOSS: A way to provide an investigational therapy to a patient who is not eligible
to receive that therapy in a clinical trial, but who has a serious or life-threatening
illness for which other treatments are not available. Compassionate use trials allow
patients to receive promising but not yet fully studied or approved cancer therapies
when no other treatment option exists.; CDISC-GLOSS: 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. NOTE:
The intent is treatment, as opposed to research. Individual, Intermediate-size, and
Widespread Use Expanded Access, also Emergency IND, are all programs administered
under FDA guidelines. Additionally, the US Right-to-Try Act, which is independent
of FDA, expands access. [FDA Expanded Access: Information for Physicians];
Codes from synonyms : CDR0000046526; CDR0000346520;
Origin ID : C71724;
UMLS CUI : C2718014;
Automatic exact mappings (from CISMeF team)
- Semantic type(s)
- UMLS correspondences (same concept)
- concept_is_in_subset
