Preferred Label : Adequate and Well-controlled Study;
NCIt related terms : adequate and well-controlled studies;
NCIt definition : A controlled clinical study with the characteristics specified in Title 21, Section
314.126 of the FDA Code of Federal Regulations, including: a clear statement of the
objectives of the investigation and a summary of the proposed methods of analysis
in the protocol; a design that permits a valid comparison with a control to provide
a quantitative assessment of the effect; a method of subject selection that provides
adequate assurance that the subject has the disease or condition that the treatment
is directed at; a method of assigning patients to treatment and control groups that
minimizes bias and assures comparability of the groups; adequate measures taken to
minimize bias, by the subjects, observers and the data analysts; methods of assessment
of subjects' response that are well-defined and reliable; and an analysis of the results
of the study that is adequate to assess the effect of the drug or device.;
Alternative definition : CDISC-GLOSS: Studies used to support drug marketing authorization and intended to
provide substantial evidence of effectiveness required by law to support a conclusion
that a drug is effective. NOTE: For additional information see COA glossary of terms.
[After 1. FDA Clinical Outcome Assessment (COA) Glossary; 2. 21 CFR 314.126];
NCI Metathesaurus CUI : CL540328;
Origin ID : C142382;
UMLS CUI : C4684558;
Semantic type(s)
- concept_is_in_subset
