title: Statistical considerations for the design and analysis of Phase III clinical trials in prostate cancer.
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.
authors.affiliation: 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
authors.forename: Susan
authors.initials: S
authors.lastname: Halabi
mesh_terms: 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