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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Journal ArticleDOI
Sample size reassessment for a two-stage design controlling the false discovery rate.
TL;DR: A two-stage design with an adaptive interim analysis where quantities are estimated from the interim data is proposed to achieve a specific overall power in gene expression microarray and NGS-RNA-Seq experiments.
Journal ArticleDOI
Analysis of “learn-as-you-go” (LAGO) studies
TL;DR: In this article, the authors formalize standard practice in public health intervention studies and develop an estimator for the intervention effects, and prove consistency and asymptotic normality using a novel coupling argument, ensuring the validity of the test for the hypothesis of no overall intervention effect.
Journal ArticleDOI
A group sequential test for ABR detection
TL;DR: The Convolutional Group Sequential Test can be used to control the specificity of a sequentially applied ABR detection method and can reduce test time, relative to the “single shot” test, when considered across a cohort of test subjects.
Journal ArticleDOI
Longitudinal clinical trials with adaptive choice of follow-up time.
Neal Jeffries,Nancy L. Geller +1 more
TL;DR: In longitudinal studies comparing two treatments with a maximum follow-up time there may be interest in examining treatment effects for intermediate follow- up times, and several adaptive alternatives to this approach that treat the pilot and second trial as a seamless, combined entity are considered.
Dissertation
Some statistical problems in sequential meta-analysis
TL;DR: In this article, the authors proposed the use of a truncated CUSUM-type test (Gombay/) for sequential monitoring in REM, and also examined the effect of accumulating evidence in meta-analysis.
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.
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.
Journal ArticleDOI
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.