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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Dissertation
A contribution to the design and analysis of phase III clinical trials
TL;DR: In this article, the authors examined some of the possible ways of improving efficiency in phase III clinical trials, including adaptive designs, number of doses, and multiplicity correction procedures, and the difference between the weighted Bonferroni-based and pooled-based multiplicity corrections.
Journal ArticleDOI
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.