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Sample size tables for exact single-stage phase II designs.

Author(s): R A'Hern

Publication date: 2001-03-30

Keywords: Antiemetics, standards, therapeutic use, Binomial Distribution, Breast, secretion, Clinical Trials, Phase II as Topic, methods, Clinical Trials, Phase III as Topic, Exudates and Transudates, chemistry, cytology, Humans, Nausea, drug therapy, Randomized Controlled Trials as Topic, Sample Size, Statistics as Topic

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Abstract

Tables for single-phase II trials based on the exact binomial distribution are presented. These are preferable to those generated using Fleming's design, which are based on the normal approximation and can give rise to anomalous results. For example, if the upper success rate is accepted, the lower success rate, which the trial is designed to reject, may be included in the final confidence interval for the proportion being estimated. Copyright 2001 John Wiley & Sons, Ltd.

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PubMed ID:: 11252008

DOI:: 10.1002/sim.721

ScienceOpen disciplines: Chemistry

Keywords: Antiemetics,standards,therapeutic use,Binomial Distribution,Breast,secretion,Clinical Trials, Phase II as Topic,methods,Clinical Trials, Phase III as Topic,Exudates and Transudates,chemistry,cytology,Humans,Nausea,drug therapy,Randomized Controlled Trials as Topic,Sample Size,Statistics as Topic

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ScienceOpen disciplines: Chemistry

Sample size tables for exact single-stage phase II designs.

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