Journal ArticleDOI
67A Designed extension of studies based on conditional power
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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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A Calculus for Design of Two-Stage Adaptive Procedures
TL;DR: In this article, the authors propose a calculus for designing two-stage adaptive procedures and conduct an ANOVA-type study to understand the effects of different components of the specification on the performance characteristics of the design.
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A new adaptive design based on Simon's two-stage optimal design for phase II clinical trials.
TL;DR: Based on Simon's two-stage optimal design, a new adaptive one which depends on the first stage results using the restrict conditions the conditional type I error and the conditional power is proposed.
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Adaptive Clinical Trials: Overview of Phase III Designs and Challenges
TL;DR: This work provides an overview of adaptive designs that have relevance for confirmatory trials and discusses considerations that may affect whether they should or should not be used in particular trials or programs as well as the challenges that need to be addressed.
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Some Challenges With Statistical Inference in Adaptive Designs
TL;DR: For adaptive selection designs, the selection based on biomarker data for testing the correlated clinical endpoints may increase statistical uncertainty in terms of type I error probability, and most importantly the increased statistical uncertainty may be impossible to assess.
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Flexible selection of a single treatment incorporating short-term endpoint information in a phase II/III clinical trial
TL;DR: It is shown that in such a case, the familywise type I error rate may be inflated if previously proposed group sequential methods are used and the treatment selection rule is not specified in advance, and a method is proposed to avoid this inflation.
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.
Journal ArticleDOI
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.