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Phase II clinical trials with time‐to‐event endpoints: optimal two‐stage designs with one‐sample log‐rank test

Year: 2013

Type: article

Abstract: Phase II clinical trials are often conducted to determine whether a new treatment is sufficiently promising to warrant a major controlled clinical evaluation against a standard therapy. We consider single-arm phase II clinical trials with right censored survival time responses where the ordinary one-sample logrank test is commonly used for testing the treatment efficacy. For planning such clinical trials, this paper presents two-stage designs that are optimal in the sense that the expected sample size is minimized if the new regimen has low efficacy subject to constraints of the type I and type II errors. Two-stage designs, which minimize the maximal sample size, are also determined. Optimal and minimax designs for a range of design parameters are tabulated along with examples.

Source: Statistics in Medicine

DOI: 10.1002/sim.6073

Authors: Minjung Kwak, Sin‐Ho Jung

Institutions: Yeungnam University, Duke University, Samsung Medical Center

Language: English

Topic: Statistical Methods in Clinical Trials

Subfield: Statistics and Probability

Field: Mathematics

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: green

Funder: National Cancer Institute