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Author:

Yin, Huan (Yin, Huan.) | Wang, Weizhen (Wang, Weizhen.) | Zhang, Zhongzhan (Zhang, Zhongzhan.)

Indexed by:

Scopus SCIE

Abstract:

In phase II clinical trials on cancer, it is of great interest to establish the efficacy and safety of a new treatment simultaneously. Existing hypotheses may not achieve this goal effectively. We introduce two new sets of hypotheses that consider the association between the two factors, then construct the optimal two-stage designs for the hypotheses. The proposed designs strictly control the maximum type I error rate at the given nominal level alpha, maintain the minimum power at least the given I - beta, and have the smallest expected total sample size under the null hypothesis. Furthermore, an algorithm is provided to compute these designs. R-codes are given in the Supplemental Material.

Keyword:

phase II clinical trial expected sample size multinomial distribution exact test Dimensionality reduction

Author Community:

  • [ 1 ] [Yin, Huan]North China Elect Power Univ, Sch Math & Phys, Beijing, Peoples R China
  • [ 2 ] [Wang, Weizhen]Wright State Univ, Dept Math & Stat, Dayton, OH 45435 USA
  • [ 3 ] [Wang, Weizhen]Beijing Univ Technol, Fac Sci, Beijing, Peoples R China
  • [ 4 ] [Zhang, Zhongzhan]Beijing Univ Technol, Fac Sci, Beijing, Peoples R China

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Source :

STATISTICAL METHODS IN MEDICAL RESEARCH

ISSN: 0962-2802

Year: 2022

Issue: 10

Volume: 31

Page: 2021-2034

2 . 3

JCR@2022

2 . 3 0 0

JCR@2022

ESI Discipline: MATHEMATICS;

ESI HC Threshold:20

JCR Journal Grade:1

CAS Journal Grade:2

Cited Count:

WoS CC Cited Count:

SCOPUS Cited Count:

ESI Highly Cited Papers on the List: 0 Unfold All

WanFang Cited Count:

Chinese Cited Count:

30 Days PV: 0

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