| A sequential phase II/III trial for binary outcomes. | |
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MedLine Citation:
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PMID: 2160719 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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This paper describes a simple two-stage design for randomized clinical trials with a binary outcome. An early stopping criterion applies to results in the experimental arm only and seeks to evaluate that arm with respect to some external standard of efficacy. Stopping rules are similar to those commonly used in phase II designs. This design has no adverse impact on the overall type I error rate, though one must increase sample size to accommodate a modest loss in power. |
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Authors:
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B E Storer |
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Publication Detail:
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Type: Journal Article; Research Support, U.S. Gov't, P.H.S. |
Journal Detail:
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Title: Statistics in medicine Volume: 9 ISSN: 0277-6715 ISO Abbreviation: Stat Med Publication Date: 1990 Mar |
Date Detail:
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Created Date: 1990-06-26 Completed Date: 1990-06-26 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: 229-35 Citation Subset: IM |
Affiliation:
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Department of Statistics, University of Wisconsin, Medical Science Center, Madison 53706. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Antineoplastic Combined Chemotherapy Protocols
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therapeutic use Carcinoma, Non-Small-Cell Lung / drug therapy Data Interpretation, Statistical Drug Evaluation / methods* Humans Lung Neoplasms / drug therapy Randomized Controlled Trials as Topic / methods* Research Design* Selection Bias |
| Grant Support | |
ID/Acronym/Agency:
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R29-CA45313/CA/NCI NIH HHS |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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