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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Efficient adaptive designs for clinical trials of interventions for COVID-19
Nigel Stallard,Lisa V. Hampson,Norbert Benda,Werner Brannath,Thomas Burnett,Tim Friede,Peter K. Kimani,Franz Koenig,Johannes Krisam,Pavel Mozgunov,Martin Posch,James Wason,James Wason,Gernot Wassmer,John Whitehead,S. Faye Williamson,Sarah Zohar,Thomas Jaki,Thomas Jaki +18 more
TL;DR: In this article, the authors describe some of the adaptive design approaches that are available and discuss particular issues and challenges associated with their use in the pandemic setting, illustrated by details of four ongoing COVID-19 trials that have used adaptive designs.
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Bayesian adaptive designs for clinical trials
TL;DR: In this article, a Bayesian adaptive design for a comparative two-armed clinical trial using decision-theoretic approaches is proposed, where a loss function is specified, based on the cost for each patient and the costs of making incorrect decisions at the end of a trial.
Journal ArticleDOI
A Comparison of Phase II Study Strategies
TL;DR: Different phase II study strategies are compared to determine the most efficient drug development path in terms of number of patients and length of time to conclusion of drug efficacy on overall survival.
Journal ArticleDOI
Adaptive Design in Clinical Research: Issues, Opportunities, and Recommendations
TL;DR: The issues and opportunities of adaptive designs are discussed, and recommendations are made in the following aspects: study planning, trial monitoring, analysis and reporting, trial simulation, and regulatory perspectives.
Journal ArticleDOI
Efficient adaptive designs with mid-course sample size adjustment in clinical trials.
Jay Bartroff,Tze Leung Lai +1 more
TL;DR: In this paper, a new approach that involves at most three stages and is developed in the general framework of multiparameter exponential families was proposed for clinical trials in which the nuisance parameters or alternative of interest are unknown or likely to be misspecified before the trial.
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.