Journal ArticleDOI
67A Designed extension of studies based on conditional power
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TLDR
A flexible method of extending a study based on conditional power, where the significance of the treatment difference at the planned end is used to determine the number of additional observations needed and the critical value necessary after accruing those additional observations.About:
This article is published in Controlled Clinical Trials.The article was published on 1995-06-01. It has received 252 citations till now. The article focuses on the topics: Extension (predicate logic).read more
Citations
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Issues In Group Sequential/adaptive Designs
TL;DR: It is shown that in terms of expected sample size, using a group sequential design in multiple hypothesis testing is more efficient than fixed sample size designs in many scenarios.
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Two-Phase, Three-Stage Adaptive Designs in Clinical Trials
TL;DR: It is concluded that the design can be a candidate when there is no useful information on the effect size, and the two-phase, three-stage adaptive designs which can be applied to this situation are explored.
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Sample size re‐estimation for response‐adaptive randomized clinical trials
Xin Li,Feifang Hu +1 more
TL;DR: In this article , the authors proposed a sample size re-estimation procedure on response-adaptive randomized trials, where multiple stopping criteria with the allowance of early termination were used to ensure ethical and economical concerns.
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Discussion on “Second-Guessing Clinical Trial Designs” by Jonathan J. Shuster and Myron N. Chang
TL;DR: In this paper, a modification of the Shuster and Chang group sequential design is proposed, where the design is carried out in a stage-wise fashion, and the design for any group/stage is determined optimally based on the available data before that stage.
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Two-stage Adaptive Biomarker-Targeted Clinical Trial Design: Non-Parametric Bayesian and MLE Approaches
Chen Huiding,Yuan Ao,Tan Ming T +2 more
TL;DR: A nonparametric Bayesian approach for designingBiomarker targeted two-stage adaptive design in a phase IIb/IIIa setting comparing a treatment vs. a control is proposed and results indicate that with good prior information, more reasonable and robust inference than with existing parametric methods can be obtained.
References
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Journal ArticleDOI
Modification of Sample Size in Group Sequential Clinical Trials
Lu Cui,H. M. J. Hung,S.-J. Wang +2 more
TL;DR: A new group sequential test procedure is developed by modifying the weights used in the traditional repeated significance two-sample mean test, which has the type I error probability preserved at the target level and can provide a substantial gain in power with the increase of sample size.
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Adaptive design methods in clinical trials – a review
Shein-Chung Chow,Mark Chang +1 more
TL;DR: Several commonly considered adaptive designs in clinical trials are reviewed and some examples concerning the development of Velcade intended for multiple myeloma and non-Hodgkin's lymphoma are given.
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Adaptive designs in clinical trials: why use them, and how to run and report them
Philip Pallmann,Alun Bedding,Babak Choodari-Oskooei,Munyaradzi Dimairo,Laura Flight,Lisa V. Hampson,Lisa V. Hampson,Jane Holmes,Adrian Mander,Lang’o Odondi,Matthew R. Sydes,Sofia S. Villar,James Wason,James Wason,Christopher J. Weir,Graham M. Wheeler,Graham M. Wheeler,Christina Yap,Thomas Jaki +18 more
TL;DR: This tutorial paper provides guidance on key aspects of adaptive designs that are relevant to clinical triallists, and emphasises the general principles of transparency and reproducibility and suggest how best to put them into practice.
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Adaptive Designs in Clinical Drug Development—An Executive Summary of the PhRMA Working Group
TL;DR: Three particular areas where it is felt that adaptive designs can be utilized beneficially are discussed: dose finding, seamless Phase II/III trials designs, and sample size reestimation.
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Adaptive increase in sample size when interim results are promising: a practical guide with examples.
Cyrus R. Mehta,Stuart J. Pocock +1 more
TL;DR: The benefits and limitations of adaptive sample size re-estimation for phase 3 confirmatory clinical trials are discussed and those promising circumstances in which a conventional final inference can be performed while preserving the overall type-1 error are defined.