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| Research article summary (published 13 Mar 2003): |
Sequential designs for phase III clinical trials incorporating treatment selection.
Full Abstract
Most statistical methodology for phase III clinical trials focuses on the comparison of a single experimental treatment with a control. An increasing desire to reduce the time before regulatory approval of a new drug is sought has led to development of two-stage or sequential designs for trials that combine the definitive analysis associated with phase III with the treatment selection element of a phase II study. In this paper we consider a trial in which the most promising of a number of experimental treatments is selected at the first interim analysis. This considerably reduces the computational load associated with the construction of stopping boundaries compared to the approach proposed by Follman, Proschan and Geller (Biometrics 1994;
50:
325-336). The computational requirement does not exceed that for the sequential comparison of a single experimental treatment with a control. Existing methods are extended in two ways. First, the use of the efficient score as a test statistic makes the analysis of binary, normal or failure-time data, as well as adjustment for covariates or stratification straightforward. Second, the question of trial power is also considered, enabling the determination of sample size required to give specified power.Copyright 2003 John Wiley & Sons, Ltd.
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Author information
Author/s: Stallard, Nigel (N); Todd, Susan (S);
Affiliation: Medical & Pharmaceutical Statistics Research Unit, The University of Reading, P.O. Box 240, Earley Gate, Reading, Berkshire RG6 6FN, UK. n.stallard@reading.ac.uk
Journal and publication information
Publication Type: Journal Article
Journal: Statistics in medicine (Stat Med), published in England. (Language: eng)
Reference: 2003-Mar; vol 22 (issue 5) : pp 689-703
Dates: Created 2003/02/14; Completed 2003/06/11; Revised 2007/11/15;
PMID: 12587100, status: MEDLINE (last retrieval date: 11/6/2008)
Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.
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