Preferred Label : Real-world Evidence;
NCIt synonyms : RWE;
NCIt related terms : Real-World Evidence (RWE); Real World Evidence (RWE);
NCIt definition : The clinical evidence derived from analysis of Real-World Data (RWD) regarding the
usage and potential benefits or risks of a medical product. (FDA Guidance: Use of
Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. August
31, 2017);
Alternative definition : CDISC-GLOSS: The clinical evidence derived from analysis of Real-World Data (RWD)
regarding the usage and potential benefits or risks of a medical product. [After FDA
Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical
Devices. August 31, 2017; IMI-GetReal Glossary Workgroup, 2016 GetReal - Project No.
115546, WP1: Deliverable D1.3; FDA Draft Guidance, Data Standards for Drug and Biological
Product Submissions Containing Real-World Data, OCTOBER 2021] See also Real-World
Data (RWD).; MRCT-Ctr: Findings from analyzing real world data. (https://mrctcenter.org/glossaryterm/real-world-evidence-rwe/);
NCI Metathesaurus CUI : CL979053;
Origin ID : C165831;
UMLS CUI : C5237472;
Semantic type(s)
- concept_is_in_subset
