Preferred Label : Phase IIb Trial;
NCIt synonyms : Trial Phase IIB;
NCIt related terms : 2B; phase 2b; Trial Phase 2B;
NCIt definition : A clinical research protocol generally referred to as a well-controlled and pivotal
trial that aims to prove the mechanism of action of the new intervention in question.
A pivotal study will generally be well-controlled, randomized, of adequate size, and
whenever possible, double-blind.;
Alternative definition : CDISC: Later Phase 2 trials, in transition to Phase 3, where the study populations
more closely reflect the population, dosage, and condition for intended use. [Clarification
of FDA Guidance for industry end of Phase 2a meetings, September 2009; Discussion
in Peter B. Gilbert. SOME DESIGN ISSUES IN PHASE 2B VERSUS PHASE 3 PREVENTION TRIALS
FOR TESTING EFFICACY OF PRODUCTS OR CONCEPTS. Stat Med. 2010 May 10; 29(10): 1061-1071.]; CDISC-GLOSS: Later Phase 2 trials, in transition to Phase 3, where the study populations
more closely reflect the population, dosage, and condition for intended use. [Clarification
of FDA Guidance for industry end of Phase 2a meetings, September 2009; Discussion
in Peter B. Gilbert. SOME DESIGN ISSUES IN PHASE 2B VERSUS PHASE 3 PREVENTION TRIALS
FOR TESTING EFFICACY OF PRODUCTS OR CONCEPTS. Stat Med. 2010 May 10; 29(10): 1061-1071.]
See also phase, phase 2, phase 2a.;
Origin ID : C49688;
UMLS CUI : C1706096;
Automatic exact mappings (from CISMeF team)
- Semantic type(s)
- concept_is_in_subset
