Document Detail

A sequential phase II/III trial for binary outcomes.
MedLine Citation:
PMID:  2160719     Owner:  NLM     Status:  MEDLINE    
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.
B E Storer
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Publication Detail:
Type:  Journal Article; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Statistics in medicine     Volume:  9     ISSN:  0277-6715     ISO Abbreviation:  Stat Med     Publication Date:  1990 Mar 
Date Detail:
Created Date:  1990-06-26     Completed Date:  1990-06-26     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8215016     Medline TA:  Stat Med     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  229-35     Citation Subset:  IM    
Department of Statistics, University of Wisconsin, Medical Science Center, Madison 53706.
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MeSH Terms
Antineoplastic Combined Chemotherapy Protocols / therapeutic use
Carcinoma, Non-Small-Cell Lung / drug therapy
Data Interpretation, Statistical
Drug Evaluation / methods*
Lung Neoplasms / drug therapy
Randomized Controlled Trials as Topic / methods*
Research Design*
Selection Bias
Grant Support

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