A bootstrap-based test for establishing noninferiority in clinical trials

Document Type

Article

Publication Date

5-1-2006

Abstract

A randomized, active-control clinical trial setting with the objective of testing noninferiority for a continuous response variable is considered. Noninferiority margin is based on the concept of preserving a certain fraction of the active control effect. Noninferiority is established if the ratio of the lower (upper) limit of the two-sided 95% confidence interval for the treatment difference to the estimated mean of the active control is greater (less) than a certain fraction. The nominal significance level is not maintained by the above confidence interval-based noninferiority test. We use bootstrapping to derive an accurate lower (upper) limit of the same confidence interval, which approximates the nominal significance level better and improves the power. Copyright © Taylor & Francis Group, LLC.

Identifier

33646234267 (Scopus)

Publication Title

Journal of Biopharmaceutical Statistics

External Full Text Location

https://doi.org/10.1080/10543400600609478

e-ISSN

15205711

ISSN

10543406

PubMed ID

16724490

First Page

357

Last Page

363

Issue

3

Volume

16

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