Document Detail


Interim treatment selection with a flexible selection margin in clinical trials.
MedLine Citation:
PMID:  23212767     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
When several treatment arms are administered along with a control arm in a trial, dropping the non-promising treatments at an early stage helps to save the resources and expedite the trial. In such adaptive designs with treatment selection, a common selection rule is to pick the most promising treatment, for example, the treatment with the numerically highest mean response, at the interim stage. However, with only a single treatment selected for final evaluation, this selection rule is often too inflexible. We modified this interim selection rule by introducing a flexible selection margin to judge the acceptable treatment difference. Another treatment could be selected at the interim stage in addition to the empirically best one if the differences of the observed treatment effect between them do not exceed this margin. We considered the study starting with two treatment arms and a control arm. We developed hypothesis testing procedures to assess the selected treatment(s) by taking into account the interim selection process. Compared with the one-winner selection designs, the modified selection rule makes the design more flexible and practical. Copyright © 2012 John Wiley & Sons, Ltd.
Authors:
Yujun Wu; Peng-Liang Zhao
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-12-5
Journal Detail:
Title:  Statistics in medicine     Volume:  -     ISSN:  1097-0258     ISO Abbreviation:  Stat Med     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-5     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8215016     Medline TA:  Stat Med     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 John Wiley & Sons, Ltd.
Affiliation:
Biostatistics and Programming, Sanofi-Aventis US, Bridgewater, NJ 08807, U.S.A.
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