Journal article
Combining an Internal Pilot with an Interim Analysis for Single Degree of Freedom Tests
Communications in statistics. Theory and methods, Vol.39(20), pp.3717-3738
10/14/2010
DOI: 10.1080/03610920903353709
PMCID: PMC2965034
PMID: 21037942
Abstract
An internal pilot with interim analysis (IPIA) design combines interim power analysis (an internal pilot) with interim data analysis (two-stage group sequential). We provide IPIA methods for single df hypotheses within the Gaussian general linear model, including one and two group t tests. The design allows early stopping for efficacy and futility while also re-estimating sample size based on an interim variance estimate. Study planning in small samples requires the exact and computable forms reported here. The formulation gives fast and accurate calculations of power, Type I error rate, and expected sample size.
Details
- Title: Subtitle
- Combining an Internal Pilot with an Interim Analysis for Single Degree of Freedom Tests
- Creators
- John A Kairalla - Department of Health Outcomes and Policy , College of Medicine, University of FloridaKeith E Muller - Department of Health Outcomes and Policy , College of Medicine, University of FloridaChristopher S Coffey - Department of Biostatistics, School of Public Health , University of Iowa
- Resource Type
- Journal article
- Publication Details
- Communications in statistics. Theory and methods, Vol.39(20), pp.3717-3738
- DOI
- 10.1080/03610920903353709
- PMID
- 21037942
- PMCID
- PMC2965034
- NLM abbreviation
- Commun Stat Theory Methods
- ISSN
- 0361-0926
- eISSN
- 1532-415X
- Publisher
- Taylor & Francis Group
- Language
- English
- Date published
- 10/14/2010
- Academic Unit
- Biostatistics
- Record Identifier
- 9984214812502771
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