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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Testing multiple primary endpoints in clinical trials with sample size adaptation.
Yi Liu,Mingxiu Hu +1 more
TL;DR: It is shown that using alpha exhaustive designs greatly improve the power when both endpoints are effective, and the power difference between the two adaptation rules is minimal.
Journal ArticleDOI
Improving the statistical power of economic experiments using adaptive designs
TL;DR: In this article , the authors provide a concise overview of the relevant theory and illustrate the method in three different applications, including a simulation study of a hypothetical experimental design, as well as illustrations using two data sets from previous experiments.
Posted Content
Conditional Power and Friends: The Why and How of (Un)planned, Unblinded Sample Size Recalculations in Confirmatory Trials
Kevin Kunzmann,Michael J. Grayling,Kim May Lee,David S. Robertson,Kaspar Rufibach,James Wason +5 more
TL;DR: It is shown that commonly discussed sample size recalculation rules lead to paradoxical adaptations where an initially planned optimal design is not invariant under the adaptation rule even if the planning assumptions do not change, and two alternatives are proposed to avoid such inconsistencies.
Journal ArticleDOI
Utility of Adaptive Sample Size Designs and A Review Example
TL;DR: Kohei Uemura Shin-kasumigaseki Bldg. 3-3-2, Kasumicaseki, Chiyoda-ku, Tokyo 100-0013, Japan Phone : +81-3.3506-9487, Facsimile: +81 -3-350 6-9567, E-mail: uemura-kohei@pmda.go.jp
Adaptive, Group Sequential Designs that Balance the Benefits and Risks of Wider Inclusion Criteria
TL;DR: In this paper, the authors proposed a new class of adaptive randomized trial designs aimed at gaining the advantages of wider generalizability and faster recruitment, while mitigating the risks of including a population for which there is greater a priori uncertainty.
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.
Journal ArticleDOI
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.