Open AccessProtocol adherence rates in superiority and noninferiority randomized clinical trials published in high impact medical journals
Author(s) -
Nicolas A. Bamat,
Osayame A. Ekhaguere,
Lingqiao Zhang,
Dustin D. Flannery,
Sara C. Handley,
Heidi M. Herrick,
Susan S. Ellenberg
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 - 10.1177/1740774520941428
Subject(s) - medicine , randomized controlled trial , protocol (science) , interquartile range , clinical trial , observational study , sample size determination , research design , intention to treat analysis , alternative medicine , pathology , social science , statistics , mathematics , sociology
Noninferiority clinical trials are susceptible to false confirmation of noninferiority when the intention-to-treat principle is applied in the setting of incomplete trial protocol adherence. The risk increases as protocol adherence rates decrease. The objective of this study was to compare protocol adherence and hypothesis confirmation between superiority and noninferiority randomized clinical trials published in three high impact medical journals. We hypothesized that noninferiority trials have lower protocol adherence and greater hypothesis confirmation.