Journal ArticleDOI
67A Designed extension of studies based on conditional power
Reads0
Chats0
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
More filters
Journal ArticleDOI
Repeated confidence intervals for adaptive group sequential trials
TL;DR: It is shown how the principle of preserving the null conditional rejection probability of the remainder of the trial at the time of each adaptive change may be extended to construct one-sided confidence intervals by applying the idea to a sequence of dual tests derived from the repeated confidence intervals (RCIs) proposed by Jennison and Turnbull.
Journal ArticleDOI
Review of Draft FDA Adaptive Design Guidance
Thomas D. Cook,David L. DeMets +1 more
TL;DR: While scarce resources and ethical imperatives motivate serious consideration of adaptive designs, researchers should be fully aware of the advantages and disadvantages ofadaptive designs and adopt them cautiously.
Journal ArticleDOI
Optimal conditional error functions for the control of conditional power.
Werner Brannath,Peter Bauer +1 more
TL;DR: Two-stage designs with control of overall and conditional power are constructed that minimize the expected sample size, either for a simple point alternative or for a random mixture of alternatives given by a prior density for the efficacy parameter.
Journal ArticleDOI
Interim Design Modifications in Time-to-Event Studies
Sebastian Irle,Helmut Schäfer +1 more
TL;DR: The proposed flexible method for interim design modifications in time-to-event studies is an extension of the so-called conditional rejection probability (CRP) principle, based on the conditional distribution of the test statistic given the final value of the same test statistic from a subsample, namely the learning sample.
Journal ArticleDOI
Adaptive clinical trial designs in oncology.
Yong Zang,J. Jack Lee +1 more
TL;DR: This article discusses practical issues from the perspective of using adaptive designs in oncology trials and investigates several aspects of the designs, including the dose-finding scheme, interim analysis, adaptive randomization, biomarker-guidedrandomization, and seamless designs.
References
More filters
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.