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13 - Non-Inferiority Trials

from Section 3

Published online by Cambridge University Press:  05 May 2012

By
Rick Chappell
Edited by
Bernard Ravina ,
Jeffrey Cummings ,
Michael McDermott  and
R. Michael Poole
Bernard Ravina
Affiliation:
Biogen Idec., Cambridge, MA
Jeffrey Cummings
Affiliation:
Cleveland Clinic, Lou Ruvo Center for Brain Health, Las Vegas
Michael McDermott
Affiliation:
University of Rochester
R. Michael Poole
Affiliation:
AstraZeneca PLC, Waltham, MA, US
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Summary

This chapter mentions multi-arm randomized trials in multiple hypothesis testing and non-inferiority trials with more than two treatments. Randomization is as central to the conduct of noninferiority as it is to superiority trials. Well-defined endpoints, clearly prioritized and stated in advance, are important components of powerful trials yielding useful results. As with most aspects of the analysis of a randomized clinical trial, the standard to which the worst performance of the treatment vs. the control is to be compared should be specified in advance. Non-inferiority trials can make useful scientific contributions when ethical considerations disallow a placebo or other inactive control. However, unlike the scenario of a superiority trial with a placebo, their assay sensitivity is not directly ensured by randomized comparison and so there are numerous cautions in their use. The measures of study quality mentioned in key comparisons between superiority and noninferiority trials are examined.

Keywords

neurological disorderspharmacodynamic biomarkersanimal CNS disease modelsCNS drug developmentcentral nervous systemblood brain barrier
Type
Chapter
Information
Clinical Trials in Neurology
Design, Conduct, Analysis
 , pp. 135 - 146
Publisher: Cambridge University Press
Print publication year: 2012

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