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.

Editorial

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.

Ernest Spitzer^{1

2}, Christopher P Cannon³, Patrick W Serruys⁴

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.

No abstract available

Keywords: Pragmatic trials; randomized controlled trials; real-world data; real-world evidence.

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.