Should real-world evidence be incorporated into regulatory approvals?

Ernest Spitzer; Christopher P. Cannon; Patrick W. Serruys

doi:10.1080/14740338.2018.1546842

Should real-world evidence be incorporated into regulatory approvals?

Ernest Spitzer
, Christopher P. Cannon
, Patrick W. Serruys

Cardialysis BV
Erasmus MC
Brigham and Women's Hospital
Imperial College London

Research output: Contribution to a Journal (Peer & Non Peer) › Editorial

15 Citations (Scopus)

Original language	English
Pages (from-to)	1155-1159
Number of pages	5
Journal	Expert Opinion on Drug Safety
Volume	17
Issue number	12
DOIs	https://doi.org/10.1080/14740338.2018.1546842
Publication status	Published - 2 Dec 2018
Externally published	Yes

Keywords

Pragmatic trials
randomized controlled trials
real-world data
real-world evidence

Access to Document

10.1080/14740338.2018.1546842

Cite this

@article{b0c5f4d5a10446da91986f325d01d8b3,

title = "Should real-world evidence be incorporated into regulatory approvals?",

keywords = "Pragmatic trials, randomized controlled trials, real-world data, real-world evidence",

author = "Ernest Spitzer and Cannon, \{Christopher P.\} and Serruys, \{Patrick W.\}",

year = "2018",

month = dec,

day = "2",

doi = "10.1080/14740338.2018.1546842",

language = "English",

volume = "17",

pages = "1155--1159",

journal = "Expert Opinion on Drug Safety",

issn = "1474-0338",