An Investigation and Review of Futility Analysis Methods in Phase III Oncology Trials.
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Authors
Winch, Chad
Date
2012-12-12
Type
thesis
Language
eng
Keyword
Oncology , Statistical Methods , Randomized Clinical Trials , Futility Analysis
Alternative Title
Abstract
The general objective of this thesis was to improve understandings of design, conduct and analysis of randomized controlled trials (RCTs). The specific objective was to evaluate the methodological and statistical principles associated with conducting analyses of futility, a component of interim analysis, as part of the conduct of RCTs. This objective was addressed by first performing a systematic review, which included a detailed literature search, as well as data from a cohort of previously extracted studies. The systematic review was designed to identify futility analysis principles and methodologies in order to inform the design and conduct of retrospective futility analyses of two completed NCIC CTG trials. The results of these trials have been previously published; one trial met its stated endpoint and the other did not. Neither trial underwent an interim analysis of futility during its conduct. The retrospective futility analyses assessed the accuracy of frequently used methods, by comparing the results of each method to each other and to the original final analysis results. These assessments were performed at selected time points using both aggressive and conservative stopping rules. In order to increase the robustness of the comparisons, bootstrapping methods were applied. The results of this thesis demonstrate principles associated with the conduct of futility analyses and provide a basis for hypotheses-testing of optimum methodologies and their associated trade-offs.
Description
Thesis (Master, Community Health & Epidemiology) -- Queen's University, 2012-12-12 13:10:15.619
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This publication is made available by the authority of the copyright owner solely for the purpose of private study and research and may not be copied or reproduced except as permitted by the copyright laws without written authority from the copyright owner.