| / English Dictionary |
CLINICAL TRIAL
| Pronunciation (US): |  | (GB): | |
I. (noun)
Sense 1
Meaning:
A rigorously controlled test of a new drug or a new invasive medical device on human subjects; in the United States it is conducted under the direction of the FDA before being made available for general clinical use
Synonyms:
Classified under:
Nouns denoting acts or actions
Hypernyms ("clinical trial" is a kind of...):
run; test; trial (the act of testing something)
Hyponyms (each of the following is a kind of "clinical trial"):
phase I; phase I clinical trial (a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained)
phase II; phase II clinical trial (a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored)
phase III; phase III clinical trial (a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA)
phase IV; phase IV clinical trial (sometimes the FDA approves a drug for general use but requires the manufacturer to continue to monitor its effects; during this phase the drug may be tried on slightly different patient populations than those studied in earlier trials)
Context examples:
The Clinical Center supports clinical trials conducted by the 27 Institutes and Centers of the NIH, including the National Cancer Institute (NCI).
(NIH Clinical Center, NCI Thesaurus)
A grant that uses materials from some other clinical trial.
(Adjunct Clinical Trial, NCI Thesaurus)
In a scientific research study or clinical trial, a flaw in the study design or the method of collecting or interpreting information.
(Bias, NCI Dictionary)
Information may come from many sources, including patient statistics, tissue specimens, genetics research, and clinical trials.
(Bioinformatics, NCI Dictionary)
A clinical trials cooperative group supported by the NCI.
(National Surgical Adjuvant Breast and Bowel Project, NCI Thesaurus)
Clinical trial conducted according to a single protocol but at more than one site, and, therefore, carried out by more than one investigator. [ICH E9 Glossary]
(Multi-Institutional Clinical Trial, NCI Thesaurus/CDISC)
Patient entry into NWTSG clinical trial protocols was completed in 2002.
(National Wilms' Tumor Study Group, NCI Thesaurus)
Comprehensive Cancer Centers are expected to initiate and conduct early-phase, innovative clinical trials and to participate in the NCI's cooperative groups by providing leadership and recruiting patients for trials.
(NCI-Designated Comprehensive Cancer Center, NCI Thesaurus)
A tool to assess response to therapy in clinical trials for chronic Graft versus Host Disease (cGVHD).
(NIH Consensus Response Criteria for cGVHD, NCI Thesaurus)
A clinical trial that is carried out at more than one medical institution.
(Multi-Institutional Clinical Trial, NCI Dictionary)
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