| Stopping clinical trials because of treatment ineffectiveness: a comparison of a futility design with a method of stochastic curtailment. | |
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MedLine Citation:
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PMID: 12587099 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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This paper introduces a simple futility design that allows a comparative clinical trial to be stopped due to lack of effect at any of a series of planned interim analyses. Stopping due to apparent benefit is not permitted. The design is for use when any positive claim should be based on the maximum sample size, for example to allow subgroup analyses or the evaluation of safety or secondary efficacy responses. A final frequentist analysis can be performed that is valid for the type of design employed. Here the design is described and its properties are presented. Its advantages and disadvantages relative to the use of stochastic curtailment are discussed. |
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Authors:
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John Whitehead; Tatsuru Matsushita |
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Publication Detail:
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Type: Comparative Study; Journal Article |
Journal Detail:
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Title: Statistics in medicine Volume: 22 ISSN: 0277-6715 ISO Abbreviation: Stat Med Publication Date: 2003 Mar |
Date Detail:
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Created Date: 2003-02-14 Completed Date: 2003-06-11 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 8215016 Medline TA: Stat Med Country: England |
Other Details:
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Languages: eng Pagination: 677-87 Citation Subset: IM |
Copyright Information:
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Copyright 2003 John Wiley & Sons, Ltd. |
Affiliation:
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Medical and Pharmaceutical Statistics Research Unit, The University of Reading, Reading, UK. j.r.whitehead@reading.ac.uk |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Data Interpretation, Statistical* Fatigue Syndrome, Chronic / drug therapy Humans Numerical Analysis, Computer-Assisted Randomized Controlled Trials as Topic / methods* Research Design* Sample Size Stochastic Processes Treatment Outcome |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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