Open AccessNon-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials
Author(s) -
Behnood Bikdeli,
César Caraballo,
John Welsh,
Joseph S. Ross,
Sanjay Kaul,
Gregg W. Stone,
Harlan M. Krumholz
Publication year - 2020
Publication title -
clinical trials
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.559
H-Index - 63
eISSN - 1740-7753
pISSN - 1740-7745
DOI - 10.1177/1740774520949157
Subject(s) - surrogate endpoint , clinical endpoint , medicine , clinical trial , endpoint determination , concordance , randomized controlled trial , intensive care medicine
Non-inferiority trials are increasing in cardiovascular medicine, with approval of many drugs and devices on the basis of such studies. Surrogate markers as primary endpoints have been also more frequently used for efficient assessment of cardiovascular interventions. However, there is uncertainty about their concordance with clinical outcomes. Non-inferiority design using a surrogate marker as a primary endpoint may pose particular challenges in clinical interpretation. We sought to explore the publication trends, methodology, and reporting features of non-inferiority cardiovascular trials that used a primary surrogate marker as the primary endpoint.