Phase III Trial

Preferred Label : Phase III Trial;

NCIt synonyms : Phase 3 Study; Phase III Clinical Trial; Phase III Protocol; Phase III Study; Phase III Trials; Clinical Trials, Phase III;

NCIt related terms : Trial Phase 3; 3; Phase 3;

NCIt definition : A clinical research protocol designed to investigate the efficacy of the biomedical or behavioral intervention in large groups of human subjects (from several hundred to several thousand), to confirm efficacy, to monitor adverse reactions to the new medication or treatment regimen with respect to long-term use and by comparing the intervention to other standard or experimental interventions as well as to a placebo.;

Alternative definition : CDISC-GLOSS: Phase that includes the controlled clinical trials intended to confirm safety and effectiveness, evaluate the overall benefit-risk relationship, and to provide substantial evidence for regulatory approval and labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [After ICH E8; Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Draft Guidance for Industry. December 2019] See also phase, phase 3b.; CDISC: Phase that includes the controlled clinical trials intended to confirm safety and effectiveness, evaluate the overall benefit-risk relationship, and to provide substantial evidence for regulatory approval and labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [After ICH E8; Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Draft Guidance for Industry. December 2019] See also phase, phase 3b. (CDISC Glossary); NCI-GLOSS: A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.;

Codes from synonyms : CDR0000045833;

Details

Origin ID

C15602;

UMLS CUI

C0282461;

Automatic exact mappings (from CISMeF team)
- -3 (qualifier value) [SNOMED CT concept]
- 3 (qualifier value) [SNOMED CT concept]
- 3 phase [LOINC part]
- 3 phase [LOINC part]
- Arabic numeral 3 (qualifier value) [Inactive SNOMED CT concept]
- HIPAA Attachments [LOINC Class]
- Phase 3 [ICD-11 Extension code]
- Phase 3 (qualifier value) [SNOMED CT concept]
- clinical trials, phase iii as topic [MeSH Descriptor]
- coiled-coil and C2 domain containing 1A [HGNC gene]
- enoyl-CoA delta isomerase 1 [HGNC gene]
Currated CISMeF NLP mapping
- clinical trial, phase III [MeSH concept]
- clinical trial, phase iii [MeSH publication type]
Semantic type(s)
- Research Activity [UMLS semantic type]
UMLS correspondences (same concept)
- clinical trials, phase III as topic [MeSH concept]
- clinical trials, phase iii as topic [MeSH Descriptor]
concept_is_in_subset
- CDISC Glossary Terminology [NCIt concept]
- CDISC Protocol Terminology [NCIt concept]
- CDISC SDTM Terminology [NCIt concept]
- CDISC SDTM Trial Phase Terminology [NCIt concept]
- Clinical Data Interchange Standards Consortium Terminology [NCIt concept]
- HL Authorized Value Terminology [NCIt concept]
- HL Subject Characteristics Table [NCIt concept]

Keyword's position in hierarchy(ies) :

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