Format

Send to

Choose Destination
See comment in PubMed Commons below
Stat Med. 2013 Dec 20;32(29):5172-218. doi: 10.1002/sim.5990. Epub 2013 Sep 30.

Traditional multiplicity adjustment methods in clinical trials.

Author information

1
Quintiles, Inc., Durham, NC, U.S.A.

Abstract

This tutorial discusses important statistical problems arising in clinical trials with multiple clinical objectives based on different clinical variables, evaluation of several doses or regiments of a new treatment, analysis of multiple patient subgroups, etc. Simultaneous assessment of several objectives in a single trial gives rise to multiplicity. If unaddressed, problems of multiplicity can undermine integrity of statistical inferences. The tutorial reviews key concepts in multiple hypothesis testing and introduces main classes of methods for addressing multiplicity in a clinical trial setting. General guidelines for the development of relevant and efficient multiple testing procedures are presented on the basis of application-specific clinical and statistical information. Case studies with common multiplicity problems are used to motivate and illustrate the statistical methods presented in the tutorial, and software implementation of the multiplicity adjustment methods is discussed.

KEYWORDS:

clinical trials; multiple testing procedures; multiplicity adjustments; multiplicity problems; type I error rate

PMID:
24114861
DOI:
10.1002/sim.5990
[Indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Loading ...
    Support Center