title: Statistical decisions and the interim analyses of clinical trials.
abstract: This paper analyzes statistical decisions during the interim analyses of clinical trials. After some general remarks about the ethical and scientific demands of clinical trials, I introduce the notion of a hard-case clinical trial, explain the basic idea behind it, and provide a real example involving the interim analyses of zidovudine in asymptomatic HIV-infected patients. The example leads me to propose a decision analytic framework for handling ethical conflicts that might arise during the monitoring of hard-case clinical trials. I use computer simulations to show how the framework can assist in reconciling certain ethical conflicts. The framework is partial, lacking the precision of a complete systematization of statistical monitoring procedures in practice.
authors.affiliation: Department of Philosophy, University of British Columbia, 1866 Main Mall E370, Vancouver, BC V6T 1Z1, Canada. rstanev@interchange.ubc.ca
authors.forename: Roger
authors.initials: R
authors.lastname: Stanev
mesh_terms: D019380:Anti-HIV Agents / Q000627:therapeutic use; D001499:Bayes Theorem; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000379:methods* / Q000639:trends; D003627:Data Interpretation, Statistical; D003657:Decision Making / Q000941:ethics*; D015658:HIV Infections / Q000188:drug therapy; D006801:Humans; D008432:Mathematical Computing; D015337:Multicenter Studies as Topic / Q000941:ethics / Q000379:methods; D012107:Research Design / Q000639:trends*; D013223:Statistics as Topic / Q000379:methods; D015215:Zidovudine / Q000627:therapeutic use
chemical_list: D019380:Anti-HIV Agents; D015215:Zidovudine