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The “Coming of Age” of Real‐World Evidence in Drug Development and Regulation
Author(s) -
Honig Peter K
Publication year - 2022
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.2465
Subject(s) - enthusiasm , globe , drug development , real world evidence , regulatory science , drug approval , drug , drug discovery , randomized controlled trial , population , data science , medicine , pharmacology , computer science , psychology , bioinformatics , biology , environmental health , pathology , social psychology , ophthalmology
Real world evidence (RWE) has the potential to inform drug discovery, development, and regulatory decision making. The emergence and availability of large population‐based datasets around the globe have stoked enthusiasm in the research community. However, much work remains to refine research methodologies, evolve the science, and define the place of RWE as a complementary source of evidence to randomized controlled trials.