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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A Two-Stage Adaptive Design in Phase 2 Clinical Trials for Acute Treatment of Migraine
TL;DR: An adaptive two-stage dose-finding design is introduced that combines traditional phase 2a and 2b to serve the dual purpose of proof of concept and dose finding through the use of an unblinded interim analysis that provides an opportunity for adaptation.
Optimal Design and Adaptive Design in Stereology
TL;DR: This dissertation focuses on studies that examine the number of neurons in a brain region of interest using stereological techniques in order to compare subjects in different diagnostic groups, e.
A Multistage Non?inferiority Study Analysis Plan to Evaluate Successively More Stringent Criteria for a Clinical Trial with Rare Events
TL;DR: Li et al. as discussed by the authors presented a multistage clinical trial to assess a sequence of hypotheses in the noninferiority and also rare events setting, and three successive hypotheses are used to evaluate whether the new treatment meets the criteria for new drug approval.
Examination of novel statistical designs for phase II and phase III clinical trials
TL;DR: This book discusses the history and present situation of black-and-white photographs, as well as some of the approaches and methods used to evaluate their rarity and quality.
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.
Journal ArticleDOI
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.