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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Journal ArticleDOI
Adaptive sample size calculations in group sequential trials.
Walter Lehmacher,Gernot Wassmer +1 more
TL;DR: A method for group sequential trials that is based on the inverse normal method for combining the results of the separate stages is proposed, which enables data-driven sample size reassessments during the course of the study.
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.
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Adaptive Group Sequential Designs for Clinical Trials: Combining the Advantages of Adaptive and of Classical Group Sequential Approaches
Hans-Helge Müller,Helmut Schäfer +1 more
TL;DR: A general method is presented integrating the concept of adaptive interim analyses into classical group sequential testing to allow the researcher to represent every group sequential plan as an adaptive trial design and to make design changes during the course of the trial after every interim analysis.
References
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Journal ArticleDOI
Flexible Interim Analyses in Clinical Trials Using Multistage Adaptive Test Designs
TL;DR: In this article, several methods were proposed that enable a flexible design through the use of adaptive interim analyses while maintaining the type I error rate and a strategy that copes well with the demands of practice is recommended.
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Adaptive clinical trial designs with pre-specified rules for modifying the sample size: understanding efficient types of adaptation
TL;DR: Insight is provided into what are good and bad choices of adaptive sampling plans when the added flexibility of adaptive designs is desired, demonstrating in realistic settings that simple and easily implemented pre-specified adaptive designs provide only very small efficiency gains over group sequential designs with the same number of analyses.
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Minimizing the Maximum Expected Sample Size in Two-Stage Phase II Clinical Trials with Continuous Outcomes
James Wason,Adrian Mander +1 more
TL;DR: The proposed design performs well for a wider range of treatment effects and so is useful for Phase II trials and compared to a previously used optimal design, which has superior expected sample size properties.
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Adaptive design of confirmatory trials: Advances and challenges.
TL;DR: An overview of the developments and associated statistical methods in several classes of adaptive designs of confirmatory trials and their statistical difficulties and implementation challenges, and how these problems are connected to other branches of mainstream Statistics are shown.
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Sequential and Multiple Testing for Dose-Response Analysis
TL;DR: In this article, the principles of multiple comparisons and interim analyses can be combined inflexible and adaptive strategies for dose-response analyses; these procedures control the experimentwise error rate.