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Author:

Yin, Huan (Yin, Huan.) | Wang, Weizhen (Wang, Weizhen.) | Zhang, Zhongzhan (Zhang, Zhongzhan.) (Scholars:张忠占)

Indexed by:

Scopus SCIE PubMed

Abstract:

When establishing an effective treatment with binary data in a two-stage design, one-sided tests for a proportion p are employed. Researchers use the parameter configuration at the boundary of the null hypothesis space to determine a rejection region and an optimal design. However, it is unclear whether the (maximum) Type I error rate is achieved at the boundary especially when the sample size in stage 2 varies. In this paper, we first prove that this is true for a large family of tests in adaptive two-stage designs by showing that any test in the family has a nondecreasing power in p and then derive optimal designs. Second, similar results are established for m-stage designs with m > 2. Supplementary materials for this article are available online.

Keyword:

phase II clinical trial Type I error rate power sample size Binomial distribution

Author Community:

  • [ 1 ] [Yin, Huan]Beijing Univ Technol, Coll Appl Sci, Beijing, Peoples R China
  • [ 2 ] [Zhang, Zhongzhan]Beijing Univ Technol, Coll Appl Sci, Beijing, Peoples R China
  • [ 3 ] [Wang, Weizhen]Wright State Univ, Dept Math & Stat, Dayton, OH 45435 USA

Reprint Author's Address:

  • [Wang, Weizhen]Wright State Univ, Dept Math & Stat, Dayton, OH 45435 USA

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Source :

STATISTICAL METHODS IN MEDICAL RESEARCH

ISSN: 0962-2802

Year: 2019

Issue: 8

Volume: 29

Page: 2269-2281

2 . 3 0 0

JCR@2022

ESI Discipline: MATHEMATICS;

ESI HC Threshold:54

JCR Journal Grade:3

Cited Count:

WoS CC Cited Count: 1

SCOPUS Cited Count: 1

ESI Highly Cited Papers on the List: 0 Unfold All

WanFang Cited Count:

Chinese Cited Count:

30 Days PV: 0

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