Should real-world evidence be incorporated into regulatory approvals?

doi:10.1080/14740338.2018.1546842

Editorial

. 2018 Dec;17(12):1155-1159.

doi: 10.1080/14740338.2018.1546842. Epub 2018 Nov 14.

Should real-world evidence be incorporated into regulatory approvals?

Ernest Spitzer^{1

2}, Christopher P Cannon³, Patrick W Serruys⁴

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

Editorial

Should real-world evidence be incorporated into regulatory approvals?

Ernest Spitzer et al. Expert Opin Drug Saf. 2018 Dec.

. 2018 Dec;17(12):1155-1159.

doi: 10.1080/14740338.2018.1546842. Epub 2018 Nov 14.

Authors

Ernest Spitzer^{1

2}, Christopher P Cannon³, Patrick W Serruys⁴

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.

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Comment on

Pragmatic Trials.
Ford I, Norrie J. Ford I, et al. N Engl J Med. 2016 Aug 4;375(5):454-63. doi: 10.1056/NEJMra1510059. N Engl J Med. 2016. PMID: 27518663 No abstract available.

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Should real-world evidence be incorporated into regulatory approvals?

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Should real-world evidence be incorporated into regulatory approvals?

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