Should real-world evidence be incorporated into regulatory approvals?
Expert Opin Drug Saf
.
2018 Dec;17(12):1155-1159.
doi: 10.1080/14740338.2018.1546842.
Epub 2018 Nov 14.
Authors
Ernest Spitzer
1
2
,
Christopher P Cannon
3
,
Patrick W Serruys
4
Affiliations
1
a Clinical Endpoint Adjudication and Data Monitoring , Cardialysis Core Laboratories and Clinical Trial Management , Rotterdam , The Netherlands.
2
b Department of Cardiology , Thoraxcenter, Erasmus University Medical Center , Rotterdam , The Netherlands.
3
c Cardiovascular Medicine Innovation , Brigham and Women's Hospital, Harvard Medical School , Boston , MA , USA.
4
d International Centre for Circulatory Health, NHLI , Imperial College London , London , UK.
PMID:
30412009
DOI:
10.1080/14740338.2018.1546842
No abstract available
Keywords:
Pragmatic trials; randomized controlled trials; real-world data; real-world evidence.
Publication types
Editorial
Comment
MeSH terms
Humans
Research Design*