Journal ArticleDOI
Sounding Board. Reasonableness and randomization in clinical trial: fundamental law and government regulation.
TLDR
The basic law of this country, the common law, has dealt very little with the complex issues of human rights presented by randomization.Abstract:
The basic law of this country, the common law, has dealt very little with the complex issues of human rights presented by randomization. The fundamental legal approach to this subject would start w...read more
Citations
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Journal ArticleDOI
Randomized consent designs for clinical trials: an update.
TL;DR: The main ideas of randomized consent designs (single and double) and the statistical model underlying the analysis are reviewed, and some recent experiences are presented.
Journal ArticleDOI
Ethics and Statistics in Randomized Clinical Trials
TL;DR: It is concluded that statisticians should be more sensitive to the physician's responsibility to the individ- ual patient and should work to improve the planning, execution, and analysis of nonrandomized clinical studies.
Journal ArticleDOI
Randomization designs in comparative clinical trials.
TL;DR: A modification of this randomization procedure, the "randomized-consent design," has recently been introduced into the practice of clinical trials to eliminate what many physicians feel to be a most uncomfortable and difficult aspect of randomized clinical trials: having to obtain the patient's consent.
Journal ArticleDOI
Managing attrition in clinical research
TL;DR: In this article, the authors provide a comprehensive approach to attrition, examining the possible impact of this occurrence at each phase of the study and propose a statistical bracketing procedure that compares two methods with opposing biases to yield greater confidence in the validity of the results.
Journal ArticleDOI
Quantifying and documenting prior beliefs in clinical trials
Kathryn Chaloner,Frank S. Rhame +1 more
TL;DR: It is shown how the documented opinions can be used to augment the monitoring process; the prior opinions are updated with interim data using approximate Bayesian methods to give posterior opinions incorporating interim results.