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Adaptive vs. Group Sequential Self‐designing Trials
Biometrical Journal, 2006AbstractThis is a discussion of the paper. ‘Repeated Confidence Intervals in Self‐Designing Clinical Trials and Switching between Non‐Inferiority and Superinferiority’ by Joachim Hartung and Guido Knapp, appearing in this special issue on adaptive designs. (© 2006 WILEY‐VCH Verlag GmbH & Co. KGaA, Weinheim)
Devan V, Mehrotra, Xiaoyin, Fan
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Group sequential design for comparative diagnostic accuracy studies
Statistics in Medicine, 2003AbstractIn the field of diagnostic medicine, comparative clinical trials are necessary for assessing the utility of one diagnostic test over another. The area under the receiver operating characteristic (ROC) curve, commonly referred to as AUC, is a general measure of a test's inherent ability to distinguish between patients with and without a ...
Madhu, Mazumdar, Aiyi, Liu
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Implementation of an adaptive group sequential design in a bioequivalence study
Pharmaceutical Statistics, 2007AbstractThe study design was a multi‐center, multiple‐dose, randomized, open‐label, 2 × 2 crossover study in patients with advanced solid tumors. Each patient was randomized to receive the test formulation or the reference formulation of the drug.
Nibedita, Bandyopadhyay +1 more
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Recent Developments in Group-Sequential Designs
2014In a group-sequential trial, patients are recruited in groups, and their response to treatment is assessed. After each group is assessed, an interim analysis is conducted. At each interim analysis, the trial can stop for futility, stop for efficacy, or continue.
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Group sequential designs for survival outcomes with adaptive randomization
Statistical Methods in Medical ResearchDriven by evolving Food and Drug Administration recommendations, modern clinical trials demand innovative designs that strike a balance between statistical rigor and ethical considerations. Covariate-adjusted response-adaptive randomization (CARA) designs bridge this gap by utilizing patient attributes and responses to skew treatment allocation in ...
Yaxian Chen, Yeonhee Park
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On Group Sequential Designs Comparing Two Binomial Proportions
Journal of Biopharmaceutical Statistics, 2009Discussed is the problem of sample size determination for one- and two-stage hypothesis tests comparing two binomial proportions using two independent random samples. A FORTRAN compiled search algorithm identifies exact group sequential designs that allow early stopping only for futility or only for efficacy or for either futility or efficacy.
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A practical guide to Bayesian group sequential designs†
Pharmaceutical Statistics, 2014Florian Gerber +2 more
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