Journal article
The choice of the noninferiority margin in clinical trials was driven by baseline risk, type of primary outcome, and benefits of new treatment
Abstract
OBJECTIVES: To explore characteristics of clinical trials that influence the choice of the noninferiority margin (NIM) when planning the trial.
STUDY DESIGN AND SETTING: We conducted an experimental survey among corresponding authors of randomized controlled trials indexed in MEDLINE. We described two hypothetical studies and asked the respondents' opinion on the largest loss of effectiveness that is clinically negligible (or the smallest lost …
Authors
Gayet-Ageron A; Agoritsas T; Rudaz S; Courvoisier D; Perneger T
Journal
Journal of Clinical Epidemiology, Vol. 68, No. 10, pp. 1144–1151
Publisher
Elsevier
Publication Date
October 2015
DOI
10.1016/j.jclinepi.2015.01.017
ISSN
0895-4356