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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Simultaneous Population and Dose Selection in Clinical Trials and Cluster Validation
TL;DR: This research considers Phase 2 clinical trials with multiple populations and multiple doses and proposes methodologies for both non-adaptive and adaptive designs to select the most desired dose and population to enter the Phase 3 confirmative clinical trials.
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Maximum type I error rate inflation from sample size reassessment when investigators are blind to treatment labels
TL;DR: It is demonstrated that the type I error rate control of these methods relies on the application of specific, binding, pre‐planned and fully algorithmic sample size reassessment rules and does not extend to general or unplanned sample size adjustments based on blinded data.
A confidence interval approach for difference and ratio of normal means in self-designing clinical trials
Joachim Hartung,Guido Knapp +1 more
TL;DR: In this article, the authors considered the effect measures difference and ratio of normal means, where the latter has not yet been considered in group sequential trials so far, and derived concrete rules for updating sample sizes and assigning weights to the stages of the trial.
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Performance of Adaptive Designs for Single-Armed Phase II Oncology Trials
Meinhard Kieser,Stefan Englert +1 more
TL;DR: This work examines comprehensively the overall performance of various Phase II oncology designs and sample size recalculation strategies and can be used to identify the most appropriate approach for a specific clinical trial situation at hand.
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A free gift: an adaptive strategy in a single-arm trial using an exact test through the binomial distribution.
TL;DR: This article shows that it is a free gift to add an adaptive component to a fixed-sample-size design so that when the interim result is marginal, the adaptive feature can be activated without any penalty.
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.