title: Quantitative Framework for Retrospective Assessment of Interim Decisions in Clinical Trials.
abstract: This article presents a quantitative way of modeling the interim decisions of clinical trials. While statistical approaches tend to focus on the epistemic aspects of statistical monitoring rules, often overlooking ethical considerations, ethical approaches tend to neglect the key epistemic dimension. The proposal is a second-order decision-analytic framework. The framework provides means for retrospective assessment of interim decisions based on a clear and consistent set of criteria that combines both ethical and epistemic considerations. The framework is broadly Bayesian and addresses a fundamental question behind many concerns about clinical trials: What does it take for an interim decision (e.g., whether to stop the trial or continue) to be a good decision? Simulations illustrating the modeling of interim decisions counterfactually are provided.
authors.affiliation: Department of Philosophy, Ottawa Hospital Research Institute, University of Ottawa, Canada rstanev@uottawa.ca.
authors.forename: Roger
authors.initials: R
authors.lastname: Stanev
mesh_terms: D001499:Bayes Theorem; D026661:Clinical Trials Data Monitoring Committees; D002986:Clinical Trials as Topic / Q000379:methods*; D003198:Computer Simulation; D003657:Decision Making; D003661:Decision Support Techniques; D006801:Humans; D012189:Retrospective Studies
keywords: Bayesian; DSMB; counterfactual reasoning; ethical framework; group sequential methods; interim analyses; statistical decisions; stopping rules