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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Finding Critical Values to Control Type I Error for a Biomarker Informed Two-Stage Winner Design
TL;DR: Adaptive clinical trial designs can assist in potentially accelerating clinical development and improving efficiency, however, the multiple interim looks and adaptive adjustments with the design can lead to inflation of type I error.
Journal ArticleDOI
Sample Size Re-estimation in Clinical Trials: Overview of Methods and the Statistical View Points to Consider
TL;DR: In this review, focusing on sample size re-estimation which is a relatively simple and basic adaptive design, some outlines of methods and review statistical points to consider are given.
Journal ArticleDOI
Stopping Boundaries of Flexible Sample Size Design With Flexible Trial Monitoring
Yi He,Zhenming Shun,Yijia Feng +2 more
TL;DR: In this article, a modified α-spending function adjusted for sample size reestimation (SSR) is proposed to maintain the Type I error level with and without sample size adjustment constraints.
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Sample size increase during a survival trial when interim results are promising
Yanning Liu,Pilar Lim +1 more
TL;DR: In this paper, the authors extend Mehta and Pocock (2011) to provide a way in doing sample size increase in survival trials by dividing the sample space by observed test statistic at interim into three zones: un...
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.
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.
Journal ArticleDOI
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.
Journal ArticleDOI
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.