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Composite and multicomponent end points in clinical trials
Author(s) -
Sankoh Abdul J.,
Li Haihong,
D'Agostino Ralph B.
Publication year - 2017
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.7386
Subject(s) - clinical trial , multiplicity (mathematics) , composite number , end point , class (philosophy) , computer science , econometrics , operations research , medicine , mathematics , algorithm , artificial intelligence , pathology , mathematical analysis , real time computing
In January 2017, the FDA released the draft guidance to industry on multiple end points in clinical trials. A class of multiplicity problems arise from the testing of individual or subset of components of a composite or multicomponent end point. This commentary attempts to further clarify these problems. Discussions include general consideration on the use of the composite and multicomponent end points, situations when multiplicity adjustments are needed, and the relevant multiple testing methods. Copyright © 2017 John Wiley & Sons, Ltd.