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Examining the Use of Real‐World Evidence in the Regulatory Process
Author(s) -
BeaulieuJones Brett K.,
Finlayson Samuel G.,
Yuan William,
Altman Russ B.,
Kohane Isaac S.,
Prasad Vinay,
Yu KunHsing
Publication year - 2020
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.1658
Subject(s) - food and drug administration , real world evidence , process (computing) , risk analysis (engineering) , regulatory science , clinical trial , business , key (lock) , drug approval , randomized controlled trial , medicine , process management , computer science , computer security , pharmacology , drug , surgery , pathology , operating system
The 21st Century Cures Act passed by the United States Congress mandates the US Food and Drug Administration to develop guidance to evaluate the use of real‐world evidence (RWE) to support the regulatory process. RWE has generated important medical discoveries, especially in areas where traditional clinical trials would be unethical or infeasible. However, RWE suffers from several issues that hinder its ability to provide proof of treatment efficacy at a level comparable to randomized controlled trials. In this review article, we summarized the advantages and limitations of RWE, identified the key opportunities for RWE, and pointed the way forward to maximize the potential of RWE for regulatory purposes.