Stallard, Nigel and Todd, Susan (2007) Statistical methods for combining clinical trial phases II and III. In: Auget, J. L. and Balakrishnan, N. and Mesbah, M. and Molenberghs, G., (eds.) Advances in Statistical Methods for the Health Sciences : Applications to Cancer and AIDS Studies, Genome Sequence Analysis, and Survival Analysis. Statistics for Industry and Technology, Part VII . Birkhäuser Boston, pp. 401-417. ISBN 9780817643683

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Abstract

This chapter reviews recently developed methodology for designs that combine clinical trial phases II and III in a single trial. The designs enable both selection of the best of a number of experimental treatments and comparison of this treatment with a control treatment, and allow the trial to be stopped early if the best experimental treatment is insufficiently promising or is clearly superior to the control. The stopping rules are constructed to preserve the overall type I error rate for the trial. Two-stage designs are reviewed briefly and two multistage methods based, respectively, on the adaptive and group-sequential approaches are described in detail. The latter are illustrated by a trial to compare three doses of a new drug for the treatment of Alzheimer's disease.

Item Type:	Book Item
Subjects:	R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine Q Science > QA Mathematics
Divisions:	Faculty of Medicine > Warwick Medical School
Series Name:	Statistics for Industry and Technology
Journal or Publication Title:	Advances in Statistical Methods for the Health Sciences: Applications to Cancer and Aids Studies, Genome Sequence Analysis, and Survival Analysis
Publisher:	Birkhäuser Boston
ISBN:	9780817643683
Book Title:	Advances in Statistical Methods for the Health Sciences : Applications to Cancer and AIDS Studies, Genome Sequence Analysis, and Survival Analysis
Editor:	Auget, J. L. and Balakrishnan, N. and Mesbah, M. and Molenberghs, G.
Official Date:	2007
Dates:	Date Event 2007 Published
Volume:	Part VII
Number of Pages:	17
Page Range:	pp. 401-417
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Restricted or Subscription Access
Conference Paper Type:	Paper
Title of Event:	International Conference on Statistics in Health Science
Type of Event:	Conference
Location of Event:	Univ Nantes, Nantes, France
Date(s) of Event:	23-25 Jun 2004

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