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
An adaptive design to bridge the gap between Phase 2b/3 microbicide effectiveness trials and evidence required for licensure.
TL;DR: A moderate increase in trial size can make the difference between a study with good power to detect a clinically meaningful effect and one which may reasonably obtain the robust evidence required for regulatory bodies and public health programs to consider making a new microbicide available to persons at risk of HIV infection.
Posted Content
A new class of self-designing clinical trials
TL;DR: In this article, 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-α-test at the end of the study preserved.
Dissertation
Adaptive designs in the time to event setting: The potential for benefit and risk
TL;DR: This research investigates how issues of information growth and time may impact scientific interpretation, and statistical credibility (control of type 1 error and study precision) and focuses on the proportional hazards setting wherein issues of calendar time and information growth are separable.
Journal ArticleDOI
Adaptive designs for Phase II oncology trials
TL;DR: The role of Phase II trials in oncology drug development acts as a screening tool by identifying treatments with sufficient activity that warrant further investigation in large and costly Phase III studies.
Posted Content
A self-designing rule for clinical trials with arbitrary response variables
TL;DR: For testing both one-sided and two-sided hypotheses concerning several treatment arms in group sequentially performed clinical trials with arbitrary outcome variables, a general method is considered that allows one to completely self-design a study.
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.