
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 S. Statistical considerations for the design and analysis of Phase III clinical trials in prostate cancer. Urol Oncol. 2008;26(3):300–7.
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.
Halabi S. Statistical considerations for the design and analysis of Phase III clinical trials in prostate cancer. Urol Oncol. 2008;26(3):300–307.

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