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Full-Text Articles in Clinical Trials
Frequentist Evaluation Of Group Sequential Clinical Trial Designs, Scott S. Emerson, John M. Kittelson, Daniel L. Gillen
Frequentist Evaluation Of Group Sequential Clinical Trial Designs, Scott S. Emerson, John M. Kittelson, Daniel L. Gillen
UW Biostatistics Working Paper Series
Group sequential stopping rules are often used as guidelines in the monitoring of clinical trials in order to address the ethical and efficiency issues inherent in human testing of a new treatment or preventive agent for disease. Such stopping rules have been proposed based on a variety of different criteria, both scientific (e.g., estimates of treatment effect) and statistical (e.g., frequentist type I error, Bayesian posterior probabilities, stochastic curtailment). It is easily shown, however, that a stopping rule based on one of those criteria induces a stopping rule on all other criteria. Thus the basis used to initially define a …
On The Use Of Stochastic Curtailment In Group Sequential Clinical Trials, Scott S. Emerson, John M. Kittelson, Daniel L. Gillen
On The Use Of Stochastic Curtailment In Group Sequential Clinical Trials, Scott S. Emerson, John M. Kittelson, Daniel L. Gillen
UW Biostatistics Working Paper Series
Many different criteria have been proposed for the selection of a stopping rule for group sequen- tial trials. These include both scientific (e.g., estimates of treatment effect) and statistical (e.g., frequentist type I error, Bayesian posterior probabilities, stochastic curtailment) measures of the evidence for or against beneficial treatment effects. Because a stopping rule based on one of those criteria induces a stopping rule on all other criteria, the utility of any particular scale relates to the ease with which it allows a clinical trialist to search for sequential sampling plans having de- sirable operating characteristics. In this paper we examine …
Constrained Boundary Monitoring For Group Sequential Clinical Trials, Bart E. Burington, Scott S. Emerson
Constrained Boundary Monitoring For Group Sequential Clinical Trials, Bart E. Burington, Scott S. Emerson
UW Biostatistics Working Paper Series
Group sequential stopping rules are often used during the conduct of clinical trials in order to attain more ethical treatment of patients and to better address efficiency concerns. Because the use of such stopping rules materially affects the frequentist operating characteristics of the hypothesis test, it is necessary to choose an appropriate stopping rule during the planning of the study. It is often the case, however, that the number and timing of interim analyses are not precisely known at the time of trial design, and thus the implementation of a particular stopping rule must allow for flexible determination of the …