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P-value calculation for multistage phase II cancer clinical trials.

Publication ,  Journal Article
Jung, S-H; Owzar, K; George, SL; Lee, T
Published in: J Biopharm Stat
2006

Due to ethical and practical issues, clinical trials are conducted in multiple stages, but the reported p-values often fail to reflect the design aspect of the trials. We investigate some approaches to p-value calculation in analyzing multi-stage Phase II clinical trials that have a binary variable, such as response, as the primary endpoint. The sample space consists of the paired outcomes of the stopping stage and the number of responses, which jointly define a complete and sufficient statistic for the true binomial proportion. Calculating a p-value requires an ordering of the paired outcomes so that outcomes more extreme than the observed can be identified. We consider the orderings based on the maximum likelihood estimator and the uniformly minimum variance unbiased estimator. We will compare, using some examples, the p-values based on these alternative orderings and the one ignoring the multistage design aspect of phase II trials.

Duke Scholars

Published In

J Biopharm Stat

DOI

ISSN

1054-3406

Publication Date

2006

Volume

16

Issue

6

Start / End Page

765 / 775

Location

England

Related Subject Headings

  • Treatment Outcome
  • Stochastic Processes
  • Statistics & Probability
  • Research Design
  • Neoplasms
  • Likelihood Functions
  • Humans
  • Endpoint Determination
  • Clinical Trials, Phase II as Topic
  • Antineoplastic Agents
 

Citation

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MLA
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Jung, S.-H., Owzar, K., George, S. L., & Lee, T. (2006). P-value calculation for multistage phase II cancer clinical trials. J Biopharm Stat, 16(6), 765–775. https://doi.org/10.1080/10543400600825645
Jung, Sin-Ho, Kouros Owzar, Stephen L. George, and Taiyeong Lee. “P-value calculation for multistage phase II cancer clinical trials.J Biopharm Stat 16, no. 6 (2006): 765–75. https://doi.org/10.1080/10543400600825645.
Jung S-H, Owzar K, George SL, Lee T. P-value calculation for multistage phase II cancer clinical trials. J Biopharm Stat. 2006;16(6):765–75.
Jung, Sin-Ho, et al. “P-value calculation for multistage phase II cancer clinical trials.J Biopharm Stat, vol. 16, no. 6, 2006, pp. 765–75. Pubmed, doi:10.1080/10543400600825645.
Jung S-H, Owzar K, George SL, Lee T. P-value calculation for multistage phase II cancer clinical trials. J Biopharm Stat. 2006;16(6):765–775.
Journal cover image

Published In

J Biopharm Stat

DOI

ISSN

1054-3406

Publication Date

2006

Volume

16

Issue

6

Start / End Page

765 / 775

Location

England

Related Subject Headings

  • Treatment Outcome
  • Stochastic Processes
  • Statistics & Probability
  • Research Design
  • Neoplasms
  • Likelihood Functions
  • Humans
  • Endpoint Determination
  • Clinical Trials, Phase II as Topic
  • Antineoplastic Agents