Accuracy, Safety, and Reliability of Novel Phase I Trial Designs
نویسندگان
چکیده
منابع مشابه
Small-sample behavior of novel phase I cancer trial designs.
BACKGROUND Novel dose-finding designs for Phase I cancer clinical trials, using estimation to assign the best estimated Maximum Tolerated Dose (MTD) at each point in the experiment, most prominently via Bayesian techniques, have been widely discussed and promoted since 1990. PURPOSE To examine the small-sample behavior of these 'Bayesian Phase I' designs, and also of non-Bayesian designs shar...
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Congratulations to the authors on a fine and comprehensive paper! The authors have uncovered an important drawback of the standard continual reassessment method (CRM) and related Bayesian Phase I (BP1) trials; namely, that they can be “sticky” in their dose allocation schemes, suffering from what the authors call “long memory.” This is the point made by the n∗ distributions shown in Figures 5-7...
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The phase II to III transition in the drug development process is associated with the highest risk compared to transition rates between other phases [1]. With increasing pressure to improve efficiency in this process it is essential that phase II trials are designed based on informed decisions, and to provide reliable results. With over 120 different phase II trial designs available [2], identi...
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ژورنال
عنوان ژورنال: Clinical Cancer Research
سال: 2018
ISSN: 1078-0432,1557-3265
DOI: 10.1158/1078-0432.ccr-18-0168