| Modification of sample size in group sequential clinical trials. | |
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MedLine Citation:
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PMID: 11315017 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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In group sequential clinical trials, sample size reestimation can be a complicated issue when it allows for change of sample size to be influenced by an observed sample path. Our simulation studies show that increasing sample size based on an interim estimate of the treatment difference can substantially inflate the probability of type I error in most practical situations. A new group sequential test procedure is developed by modifying the weights used in the traditional repeated significance two-sample mean test. The new test has the type I error probability preserved at the target level and can provide a substantial gain in power with the increase of sample size. Generalization of the new procedure is discussed. |
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Authors:
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L Cui; H M Hung; S J Wang |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S. |
Journal Detail:
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Title: Biometrics Volume: 55 ISSN: 0006-341X ISO Abbreviation: Biometrics Publication Date: 1999 Sep |
Date Detail:
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Created Date: 2001-04-20 Completed Date: 2001-08-16 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 0370625 Medline TA: Biometrics Country: United States |
Other Details:
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Languages: eng Pagination: 853-7 Citation Subset: IM |
Affiliation:
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Division of Biometrics I, OB/CDER, Food and Drug Administration, Rockville, Maryland 20852, USA. cuil@cder.fda.gov |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Biometry* Clinical Trials as Topic / statistics & numerical data* Humans Probability Sample Size |
| Grant Support | |
ID/Acronym/Agency:
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RSR-096-010A/RS/DRS NIH HHS |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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