The epistemology and ethics of early stopping decisions in randomized controlled trials

Dissertation, University of British Columbia (2012)

Authors
Roger Stanev
University of Ottawa
Abstract
Philosophers subscribing to particular principles of statistical inference and evidence need to be aware of the limitations and practical consequences of the statistical approach they endorse. The framework proposed (for statistical inference in the field of medicine) allows disparate statistical approaches to emerge in their appropriate context. My dissertation proposes a decision theoretic model, together with methodological guidelines, that provide important considerations for deciding on clinical trial conduct. These considerations do not amount to more stopping rules. Instead, they are principles that address the complexity of interpreting and responding to interim data, based on a broad range of epistemic and ethical factors. While they are not stopping rules, they would assist a Data Monitoring Committee in judging its position with regard to necessary precautionary interpretation of interim data. By vindicating a framework that accommodates a wide range of approaches to statistical inference in one important setting (clinical trials), my results pose a serious challenge for any approach that advocates a single, universal principle of statistical inference.
Keywords philosophy of science  philosophy of statistics  philosophy of medicine  randomized controlled trials  statistical evidence and inferece  Bayesian  error statistics  decision theory  HIV/AIDS  causation
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