NDLI: Hypothesis testing for two-stage designs with over or under enrollment

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Hypothesis testing for two-stage designs with over or under enrollment

Content Provider	Scilit
Author	Zeng, Donglin Gao, Fei Hu, Kuolung Jia, Catherine Ibrahim, Joseph G.
Copyright Year	2015
Description	Journal: Statistics in medicine Simon's two-stage designs are widely used in cancer phase II clinical trials for assessing the efficacy of a new treatment. However in practice, the actual sample size for the second stage is often different from the planned sample size, and the original inference procedure is no longer valid. Previous work on this problem has certain limitations in computation. In this paper, we attempt to maximize the unconditional power while controlling for the type I error for the modified second stage sample size. A normal approximation is used for computing the power, and the numerical results show that the approximation is accurate even under small sample sizes. The corresponding confidence intervals for the response rate are constructed by inverting the hypothesis test, and they have reasonable coverage while preserving the type I error.
Related Links	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4636905/pdf
Ending Page	2426
Page Count	10
Starting Page	2417
e-ISSN	10970258
DOI	10.1002/sim.6490
Journal	Statistics in medicine
Issue Number	16
Volume Number	34
Language	English
Publisher	Wiley-Blackwell
Publisher Date	2015-03-25
Access Restriction	Open
Subject Keyword	Journal: Statistics in medicine Mathematical Psychology Adaptive Design Clinical Trials Sample Size Modification
Content Type	Text

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