Document Detail

Sample size re-estimation for survival data in clinical trials with an adaptive design.
MedLine Citation:
PMID:  21031498     Owner:  NLM     Status:  Publisher    
In clinical trials with survival data, investigators may wish to re-estimate the sample size based on the observed effect size while the trial is ongoing. Besides the inflation of the type-I error rate due to sample size re-estimation, the method for calculating the sample size in an interim analysis should be carefully considered because the data in each stage are mutually dependent in trials with survival data. Although the interim hazard estimate is commonly used to re-estimate the sample size, the estimate can sometimes be considerably higher or lower than the hypothesized hazard by chance. We propose an interim hazard ratio estimate that can be used to re-estimate the sample size under those circumstances. The proposed method was demonstrated through a simulation study and an actual clinical trial as an example. The effect of the shape parameter for the Weibull survival distribution on the sample size re-estimation is presented. Copyright © 2010 John Wiley & Sons, Ltd.
Kanae Togo; Manabu Iwasaki
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2010-10-28
Journal Detail:
Title:  Pharmaceutical statistics     Volume:  -     ISSN:  1539-1612     ISO Abbreviation:  -     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-10-29     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101201192     Medline TA:  Pharm Stat     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Clinical Statistics, Pfizer Japan Inc., Tokyo, Japan.
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