Some remaining challenges regarding multiple endpoints in clinical trials. (30th June 2017)

• Record Type: Journal Article
• Authors: Snapinn, Steven
• Is Part Of: Statistics in medicine. Volume 36:Number 28(2017)
• Page Start: 4441
• Page End: 4445
• Publication Date: 2017-06-30
• Subjects: adjusted P values -- non‐inferiority -- primary endpoint; Medical statistics -- Periodicals; Statistique médicale -- Périodiques; Statistiques médicales -- Périodiques; 610.727
• DOI: 10.1002/sim.7390
• Languages: English
• ISSNs: 0277-6715

Abstract

Abstract : Despite recent advance in methods for handling multiple endpoints in clinical trials, some challenges remain. This paper discusses some of these challenges, including confusion surrounding the terminology used to describe the multiple endpoints, the justification for simultaneously testing for non‐inferiority and superiority in a non‐inferiority trial, lack of agreement on the situations under which multiple objectives do or do not lead to the need for a multiplicity correction, and choice of the most appropriate multiple comparisons procedure. In addition, this paper will discuss the position of the recent FDA draft guidance, Multiple Endpoints in Clinical Trials, on these issues. Copyright © 2017 John Wiley & Sons, Ltd.