Journal ArticleDOI
Adaptive randomization for clinical trials.
TLDR
The objective of this paper is to review several important new classes of adaptive randomization procedures and convey information on the recent developments in the literature on this topic.Abstract:
In February 2010, the U.S. Food and Drug Administration (FDA, 2010) drafted guidance that discusses the statistical, clinical, and regulatory aspects of various adaptive designs for clinical trials. An important class of adaptive designs is adaptive randomization, which is considered very briefly in subsection VI.B of the guidance. The objective of this paper is to review several important new classes of adaptive randomization procedures and convey information on the recent developments in the literature on this topic. Much of this literature has been focused on the development of methodology to address past criticisms and concerns that have hindered the broader use of adaptive randomization. We conclude that adaptive randomization is a very broad area of experimental design that has important application in modern clinical trials.read more
Citations
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The Design and Analysis of Experiments
TL;DR: This book by a teacher of statistics (as well as a consultant for "experimenters") is a comprehensive study of the philosophical background for the statistical design of experiment.
Journal ArticleDOI
Adaptive trial designs: a review of barriers and opportunities
TL;DR: This work focuses on the design principles and research issues that lead to particular designs being appealing or unappealing in particular applications, and describes a number of current barriers and suggestions for overcoming them in order to promote wider use of appropriate adaptive designs.
Journal ArticleDOI
Seven myths of randomisation in clinical trials.
TL;DR: Although one should not make a fetish of randomisation, when proposing alternatives to randomisation in clinical trials, one should be very careful to be precise about the exact nature of the alternative being considered if one is to avoid the danger of underestimating the advantages that randomisation can offer.
Journal ArticleDOI
How to Construct, Conduct and Analyze an Exercise Training Study?
TL;DR: The present scoping review covers all main aspects of planning, conducting, and analyzing exercise based RCTs and aims to focus on relevant aspects regarding study design, statistical power, training planning and documentation as well as traditional and recent statistical approaches.
Journal ArticleDOI
A simulation study of outcome adaptive randomization in multi-arm clinical trials:
J. Kyle Wathen,Peter F. Thall +1 more
TL;DR: A simulation study was conducted to evaluate four different Bayesian adaptive randomization methods and compare them to equal randomization in five-arm clinical trials, finding the only adaptive Randomization method with desirable properties has a burn-in with equal Randomization and thereafter randomization probabilities restricted to the interval 0.10–0.90.
References
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Journal Article
The Design and Analysis of Experiments
TL;DR: This book by a teacher of statistics (as well as a consultant for "experimenters") is a comprehensive study of the philosophical background for the statistical design of experiment.
Journal ArticleDOI
On the likelihood that one unknown probability exceeds another in view of the evidence of two samples
Journal ArticleDOI
Equipoise and the ethics of clinical research.
TL;DR: An alternative concept of equipoise is suggested, which would be based on present or imminent controversy in the clinical community over the preferred treatment, which is satisfied if there is genuine uncertainty within the expert medical community--not necessarily on the part of the individual investigator--about the preferredreatment.
Journal ArticleDOI
Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial.
TL;DR: A new general procedure for treatment assignment is described which concentrates on minimizing imbalance in the distributions of treatment numbers within the levels of each individual prognostic factor.
Journal ArticleDOI
Some aspects of the sequential design of experiments
TL;DR: The authors proposed a theory of sequential design of experiments, in which the size and composition of the samples are not fixed in advance but are functions of the observations themselves, which is a major advance.