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Two-stage designs for phase II cancer trials with ordinal responses
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Stallard, Nigel and Cockey, Louise. (2008) Two-stage designs for phase II cancer trials with ordinal responses. Contemporary Clinical Trials, Vol.29 (No.6). pp. 896-904. ISSN 1551-7144
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Official URL: http://dx.doi.org/10.1016/j.cct.2008.07.003
Abstract
A common approach to the design of phase II clinical trials in oncology is to conduct a two-stage trial so as to control type I and type II error rates. A number of researchers have proposed methods for the design of such trials when the response can take one of a number of ordered values such as tumor response, stable disease or progressive disease. In this case. the problem may be formulated as that of testing a complex null hypothesis. Control of the type I error rate thus requires specification of the null region and construction of a test that limits the maximum error rate over this region. In this paper we propose that the null region should be bounded by a line in the two-dimensional parameter space for the setting with a response with three levels and more generally by a plane or hyperplane. We then propose a test based on the likelihood ratio statistic and show how this may be calculated in this case for a three-level response. The method is illustrated using an example of a clinical trial to evaluate a new treatment for breast cancer. (C) 2008 Elsevier Inc. All rights reserved.
| Item Type: | Journal Article |
|---|---|
| Subjects: | R Medicine > R Medicine (General) R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer) R Medicine > RS Pharmacy and materia medica |
| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School |
| Library of Congress Subject Headings (LCSH): | Clinical trials -- Design, Multivariate analysis, Cancer -- Research, Oncology |
| Journal or Publication Title: | Contemporary Clinical Trials |
| Publisher: | Elsevier Science Inc. |
| ISSN: | 1551-7144 |
| Date: | November 2008 |
| Volume: | Vol.29 |
| Number: | No.6 |
| Number of Pages: | 9 |
| Page Range: | pp. 896-904 |
| Identification Number: | 10.1016/j.cct.2008.07.003 |
| Status: | Peer Reviewed |
| Publication Status: | Published |
| Access rights to Published version: | Restricted or Subscription Access |
| URI: | http://wrap.warwick.ac.uk/id/eprint/29025 |
Data sourced from Thomson Reuters' Web of Knowledge
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