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Harnessing the Power of Real‐World Evidence (RWE): A Checklist to Ensure Regulatory‐Grade Data Quality
Author(s) -
Miksad Rebecca A.,
Abernethy Amy P.
Publication year - 2018
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.946
Subject(s) - checklist , real world data , clinical trial , randomized controlled trial , real world evidence , health care , medicine , drug development , quality (philosophy) , intensive care medicine , pharmacology , drug , computer science , psychology , data science , surgery , political science , philosophy , epistemology , cognitive psychology , law
The role of real‐world evidence (RWE) in regulatory, drug development, and healthcare decision‐making is rapidly expanding. Recent advances have increased the complexity of cancer care and widened the gap between randomized clinical trial (RCT) results and the evidence needed for real‐world clinical decisions.[1][Sherman, R.E., 2017] Instead of remaining invisible, data from the >95% of cancer patients treated outside of clinical trials can help fill this void.