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

Journal Article (Review;Journal Article)

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

Electronic International Standard Serial Number (EISSN)

  • 1873-2496

International Standard Serial Number (ISSN)

  • 1078-1439

Digital Object Identifier (DOI)

  • 10.1016/j.urolonc.2006.11.007


  • eng