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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Adaptation in clinical development plans and adaptive clinical trial designs
TL;DR: Novel statistical methods are described that can adapt these “initializing” designs or development plans to the sequential information accumulated during the development process and show that the adaptive version of the initializing design/plan performs similarly to, or even better than, theInitializing counterpart if the underlying assumptions actually hold, but can perform much better if the initial assumptions differ substantially from reality.
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Seamless Phase II/III combination study through response adaptive randomization.
TL;DR: A seamless design based on adaptive patient allocation is proposed to combine the traditional Phase II and Phase III steps to achieve the objectives of dose identification and confirmation at the same time within one study.
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Precision of maximum likelihood estimation in adaptive designs
TL;DR: This work searches for the sample size reassessment and selection rules that lead to the maximum Bias or maximum MSE in designs that start with k treatment groups and a common control and where selection of a single treatment and control is performed at the interim analysis with the possibility to reassess each of the sample sizes.
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p-Value calculation for multi-stage additive tests
J. Sheng,Peihua Qiu +1 more
TL;DR: In this paper, an alternative and simpler definition of the overall p-value of a multi-stage additive testing procedure has been proposed, where no conditional error probability function needs to be chosen and the entire testing procedure is easy to interpret.
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A Note on Adaptively Changing the Hierarchy of Hypotheses in Clinical Trials with Flexible Design
TL;DR: In this article, the power performance of the proposed procedure of adaptively changing the hierarchy of hypotheses is compared with alternative testing strategies that do not change the initially specified structure of the hypotheses.
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.