Statistical considerations for the design and analysis of Phase III clinical trials in prostate cancer.
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.
Halabi
Susan
S
Department 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
D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data*; D004608:Eligibility Determination; D006801:Humans; D008297:Male; D011471:Prostatic Neoplasms; D011897:Random Allocation; D018401:Sample Size; D015996:Survival Rate