Sample size tables for exact single-stage phase II designs

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 l...

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Veröffentlicht in:	Statistics in medicine 2001-03, Vol.20 (6), p.859-866
1. Verfasser:	A'Hern, R. P.
Format:	Artikel
Sprache:	eng
Schlagworte:	Antiemetics - standards Antiemetics - therapeutic use Binomial Distribution Biological and medical sciences Breast - secretion Clinical Trials, Phase II as Topic - methods Clinical Trials, Phase III as Topic - methods Computerized, statistical medical data processing and models in biomedicine Exudates and Transudates - chemistry Exudates and Transudates - cytology Humans Medical sciences Medical statistics Nausea - drug therapy Randomized Controlled Trials as Topic - methods Sample Size Statistics as Topic
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Beschreibung
Zusammenfassung:	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.
ISSN:	0277-6715 1097-0258
DOI:	10.1002/sim.721