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Published on: September 20, 2019
Statistical considerations for the design and analysis of Phase III clinical trials in prostate cancer
1Department of Biostatistics and Bioinformatics and the Cancer and Leukemia Group B Statistical Center, Duke University Medical Center, Durham, NC 27705, USA. susan.halabi@duke.edu
Abstract:
This article reviews the basic principles involved in the design, conduct, and analysis of Phase III treatment trials in prostate cancer. It begins with a brief review of Phase III trials, and subsequently describes the process of hypothesis testing and the types of errors involved in the process of statistical inference. Next, it presents a general discussion of design considerations, including choice of endpoints, patient selection and eligibility criteria, randomization and stratification, methods to determine the required number patients, standard procedures to monitor a study, and finally how to analyze the results from randomized clinical trials.
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