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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.
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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
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ESI Highly Cited Papers on the List: 0 Unfold All
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30 Days PV: 0
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