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

Publication ,  Journal Article
Halabi, S
Published in: Urol Oncol
2008

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.

Duke Scholars

Published In

Urol Oncol

DOI

ISSN

1078-1439

Publication Date

2008

Volume

26

Issue

3

Start / End Page

300 / 307

Location

United States

Related Subject Headings

  • Urology & Nephrology
  • Survival Rate
  • Sample Size
  • Random Allocation
  • Prostatic Neoplasms
  • Male
  • Humans
  • Eligibility Determination
  • Clinical Trials, Phase III as Topic
  • 3211 Oncology and carcinogenesis
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Halabi, S. (2008). Statistical considerations for the design and analysis of Phase III clinical trials in prostate cancer. Urol Oncol, 26(3), 300–307. https://doi.org/10.1016/j.urolonc.2006.11.007
Halabi, Susan. “Statistical considerations for the design and analysis of Phase III clinical trials in prostate cancer.Urol Oncol 26, no. 3 (2008): 300–307. https://doi.org/10.1016/j.urolonc.2006.11.007.
Halabi, Susan. “Statistical considerations for the design and analysis of Phase III clinical trials in prostate cancer.Urol Oncol, vol. 26, no. 3, 2008, pp. 300–07. Pubmed, doi:10.1016/j.urolonc.2006.11.007.
Journal cover image

Published In

Urol Oncol

DOI

ISSN

1078-1439

Publication Date

2008

Volume

26

Issue

3

Start / End Page

300 / 307

Location

United States

Related Subject Headings

  • Urology & Nephrology
  • Survival Rate
  • Sample Size
  • Random Allocation
  • Prostatic Neoplasms
  • Male
  • Humans
  • Eligibility Determination
  • Clinical Trials, Phase III as Topic
  • 3211 Oncology and carcinogenesis