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Report on the current status of the use of real‐world data (RWD) and real‐world evidence (RWE) in drug development and regulation
Author(s) -
Breckenridge Alasdair M.,
Breckenridge Ross A.,
Peck Carl C.
Publication year - 2019
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/bcp.14026
Subject(s) - real world data , real world evidence , drug development , payment , data science , business , risk analysis (engineering) , computer science , pharmacology , drug , medicine , world wide web
Radically expanding use of real‐world data (RWD) and real‐world evidence (RWE) holds the potential to substantially impact drug development, pharmaceutical regulation, and payment within health care systems. Central to this is the reconfiguration of data gathering and transformation of data to information, which can be used as evidence for decision making. We discuss applications of this paradigm in the light of recent developments in both the United States and Europe on RWD and RWE.