Document Detail


A new futility test approach in clinical interim data monitoring.
MedLine Citation:
PMID:  23015479     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Sequential monitoring of efficacy and safety data has become a vital component of modern clinical trials. It affords companies the opportunity to stop studies early in cases when it appears as if the primary objective will not be achieved or when there is clear evidence that the primary objective has already been met. This paper introduces a new concept of the backward conditional hypothesis test (BCHT) to evaluate clinical trial success. Unlike the regular conditional power approach that relies on the probability that the final study result will be statistically significant based on the current interim look, the BCHT was constructed based on the hypothesis test framework. The framework comprises a significant test level as opposed to the arbitrary fixed futility index utilized in the conditional power method. Additionally, the BCHT has proven to be a uniformly most powerful test. Noteworthy features of the BCHT method compared with the conditional power method will be presented. Copyright © 2012 John Wiley & Sons, Ltd.
Authors:
Dixi Xue
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-9-27
Journal Detail:
Title:  Pharmaceutical statistics     Volume:  -     ISSN:  1539-1612     ISO Abbreviation:  Pharm Stat     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-9-27     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.
Affiliation:
Merck Research Laboratories, Merck & Co., Inc., Rahway, NJ, 07065, USA. dixixue@aol.com.
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