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Modern Issues and Methods in BiostatisticsAdaptive Trial Design

Modern Issues and Methods in Biostatistics: Adaptive Trial Design [The utilization of adaptive trial designs can increase the probability of success, reduce the cost, reduce the time to market, and deliver the right drug to the right patient. Two popular definitions of adaptive design are: (1) Chow and Chang’s definition that an adaptive design is a clinical trial design that allows adaptations or modification to aspects of the trial after its initiation without undermining the validity and integrity of the trial (Chow and Chang 2005), and (2) The PhRMA Working Group’s definition that adaptive design refers to a clinical trial design that uses accumulating data to decide on how to modify aspects of the study as it continues, without undermining the validity and integrity of the trial (Gallo et al. 2006). Most recently, the FDA released the draft guidance on Adaptive Design for Clinical Drugs and Biologics, where the definition of adaptive trial design is stated as “a study that includes a prospectively planned opportunity for modification of one or more specified aspects of the study design and hypotheses based on analysis of data (usually interim data) from subjects in the study. Analyses of the accumulating study data are performed at prospectively planned timepoints within the study, can be performed in a fully blinded manner or in an unblinded manner, and can occur with or without formal statistical hypothesis-testing.”] http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png

Modern Issues and Methods in BiostatisticsAdaptive Trial Design

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Publisher
Springer New York
Copyright
© Springer Science+Business Media, LLC 2011
ISBN
978-1-4419-9841-5
Pages
87 –115
DOI
10.1007/978-1-4419-9842-2_4
Publisher site
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Abstract

[The utilization of adaptive trial designs can increase the probability of success, reduce the cost, reduce the time to market, and deliver the right drug to the right patient. Two popular definitions of adaptive design are: (1) Chow and Chang’s definition that an adaptive design is a clinical trial design that allows adaptations or modification to aspects of the trial after its initiation without undermining the validity and integrity of the trial (Chow and Chang 2005), and (2) The PhRMA Working Group’s definition that adaptive design refers to a clinical trial design that uses accumulating data to decide on how to modify aspects of the study as it continues, without undermining the validity and integrity of the trial (Gallo et al. 2006). Most recently, the FDA released the draft guidance on Adaptive Design for Clinical Drugs and Biologics, where the definition of adaptive trial design is stated as “a study that includes a prospectively planned opportunity for modification of one or more specified aspects of the study design and hypotheses based on analysis of data (usually interim data) from subjects in the study. Analyses of the accumulating study data are performed at prospectively planned timepoints within the study, can be performed in a fully blinded manner or in an unblinded manner, and can occur with or without formal statistical hypothesis-testing.”]

Published: Jun 16, 2011

Keywords: Adaptive Design; Conditional Power; Expect Sample Size; Group Sequential Design; Sample Size Adjustment

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