Balancing Informativeness and Ethics in Clinical Trial Design

• Activity Number: 273
• Type: Invited
• Date/Time: Tuesday, August 3, 2010 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Valerii Fedorov*+
• Companies: GlaxoSmithKline
• Keywords: Clinical trials ; Optimal design ; Medical ethics

Abstract

Optimal design of experiments is a natural way of gaining more information given time/cost constraints in natural sciences and engineering. For decades statisticians have been contributing to creation and improvement of optimal design methods. While these methods worked almost flawlessly in those areas, they need careful modification to be used in clinical studies. Medical ethics, huge expenses, and interactions with regulatory agencies call for more meticulous analysis of stochastic models and constraints. Often the initial enthusiasm about the (mathematical) efficiency of optimal designs quickly disappears during the first discussion between a statistician and the medical team. I consider some promising compromises between the desire to get maximal information and various constraints, some of which are not easy quantifiable.