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
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Adaptive Budgets in Clinical Trials
Martin Posch,Peter Bauer +1 more
TL;DR: In situations where a drug developer gets access to additional financial resources when a promising result has been observed in a preplanned interim analysis during a clinical trial that should lead to the registration of the drug, sample size was based on a utility function including the reward of registration and sampling costs.
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Sequential Methods in Multi-Arm Clinical Trials
TL;DR: Adapt designs in “learn” clinical studies, the exploratory phase of the drug development process designed and carried out in order to establish drug efficacy and dose-response relationships, are focused on.
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Many-to-One Comparison After Sample Size Reestimation for Trials with Multiple Treatment Arms and Treatment Selection
TL;DR: It is shown that one-step and stepwise Dunnett tests can be used directly on statistics constructed in the proposed way, allowing the change of sample sizes in all arms depending on interim information.
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The WIZARD Trial as a Case Study of Flexible Clinical Trial Design
TL;DR: The WIZARD trial demonstrates the substantial flexibility in the design and conduct of group-sequential randomized trials not only during the design stage but also after the trial is under way, effectively satisfying evolving and competing demands while preserving the statistical and scientific validity of the study.
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A new class of self-designing clinical trials.
TL;DR: A class of self-designing clinical trials is considered which according to an effective but simple, finite learning algorithm consists of automatically adaptively planned weighted group sequential trials with a decision about rejection of the null-hypothesis at each step, but the full level-alpha-test at the end of the study preserved.
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.
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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.