Statistical considerations for the design and analysis of Phase III clinical trials in prostate cancer.


Journal Article (Review)

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.

Full Text

Duke Authors

Cited Authors

  • Halabi, S

Published Date

  • May 2008

Published In

Volume / Issue

  • 26 / 3

Start / End Page

  • 300 - 307

PubMed ID

  • 18452825

Pubmed Central ID

  • 18452825

International Standard Serial Number (ISSN)

  • 1078-1439

Digital Object Identifier (DOI)

  • 10.1016/j.urolonc.2006.11.007


  • eng

Conference Location

  • United States