Phase 0 Trial - CISMeF

Preferred Label : Phase 0 Trial;

NCIt synonyms : Pre-Clinical Trial;

NCIt related terms : phase 0; Trial Phase 0; 0;

NCIt definition : A clinical trial that uses an investigational agent that is available only in very limited quantities and which has never previously given to humans or for which there is extremely limited human experience. Phase 0 clinical trials are intended to enable researchers to understand the path of the drug in the body and its efficacy. Adverse event reporting in Phase 0 trials is expedited.;

Alternative definition : CDISC: First-in-human trials, in a small number of subjects, that are conducted before Phase 1 trials and are intended to assess new candidate therapeutic and imaging agents. The study agent is administered at a low dose for a limited time, and there is no therapeutic or diagnostic intent. NOTE: FDA Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies, January 2006 classifies such studies as Phase 1. NOTE: A Phase 0 study might not include any drug delivery but may be an exploration of human material from a study (e.g., tissue samples or biomarker determinations). [Improving the Quality of Cancer Clinical Trials: Workshop summary-Proceedings of the National Cancer Policy Forum Workshop, improving the Quality of Cancer Clinical Trials (Washington, DC, Oct 2007)] (CDISC glossary); CDISC-GLOSS: Originally described as an exploratory study with no safety or efficacy targets. It is not cited in current FDA guidance and no longer in common usage. See also phase.;

Origin ID

C54721;

UMLS CUI

C1882358;

Automatic exact mappings (from CISMeF team)
- 0 (qualifier value) [SNOMED CT concept]
- Phase 0 [ICD-11 Extension code]
Semantic type(s)
- Research Activity [UMLS semantic type]
concept_is_in_subset
- CDISC DDF Terminology [NCIt concept]
- 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]

Keyword's position in hierarchy(ies) :

Details

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