Document Detail

A practical comparison of blinded methods for sample size reviews in survival data clinical trials.
MedLine Citation:
PMID:  22337635     Owner:  NLM     Status:  Publisher    
This paper presents practical approaches to the problem of sample size re-estimation in the case of clinical trials with survival data when proportional hazards can be assumed. When data are readily available at the time of the review, on a full range of survival experiences across the recruited patients, it is shown that, as expected, performing a blinded re-estimation procedure is straightforward and can help to maintain the trial's pre-specified error rates. Two alternative methods for dealing with the situation where limited survival experiences are available at the time of the sample size review are then presented and compared. In this instance, extrapolation is required in order to undertake the sample size re-estimation. Worked examples, together with results from a simulation study are described. It is concluded that, as in the standard case, use of either extrapolation approach successfully protects the trial error rates. Copyright © 2012 John Wiley & Sons, Ltd.
Susan Todd; Elsa Valdés-Márquez; Jodie West
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-2-15
Journal Detail:
Title:  Pharmaceutical statistics     Volume:  -     ISSN:  1539-1612     ISO Abbreviation:  -     Publication Date:  2012 Feb 
Date Detail:
Created Date:  2012-2-16     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101201192     Medline TA:  Pharm Stat     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 John Wiley & Sons, Ltd.
Department of Mathematics and Statistics, University of Reading, Philip Lyle Building, Reading, RG6 6BX, UK.
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