Identification of the minimum non-inferior dose in a three-arm non-inferiority trial

Junjiang Zhong, Miin Jye Wen, Siu Hung Cheung

Research output: Contribution to journalArticle

Abstract

Non-inferiority (NI) trials have gained recognition as an effective tool with which to search for substitutes for a standard treatment that is associated with certain undesirable features, such as adverse side-effects, an exorbitant cost, or an extremely complicated therapeutic regimen. Statistical methods have been developed for NI studies with multiple experimental treatments. However, experimental treatments sometimes represent a new treatment with various dose levels, and in such circumstances, identification of the minimum non-inferior dose is a reasonable objective of the trial. Thus, we examine several potential testing procedures with respect to this testing objective. A simulation study is conducted to evaluate their performance, and determination of the sample size is discussed. Two clinical examples are provided to illustrate the proposed method.

Original languageEnglish
JournalJournal of the Korean Statistical Society
DOIs
Publication statusAccepted/In press - 2020 Jan 1

All Science Journal Classification (ASJC) codes

  • Statistics and Probability

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