Decision theory and the evaluation of risks and benefits of clinical trials

Research ethics committees (RECs) are tasked to assess the risks and the benefits of a clinical trial. In previous studies, it was shown that RECs find this task difficult, if not impossible, to do. The current approaches to benefit-risk assessment (i.e. Component Analysis and the Net Risk Test) confound the various risk-benefit tasks, and as such, make balancing impossible. In this article, we show that decision theory, specifically through the expected utility theory and multiattribute utility theory, enable for an explicit and ethically weighted risk-benefit evaluation. This makes a balanced ethical justification possible, and thus a more rationally defensible decision making.

► The literature provides insufficient guidance on risk-benefit assessment of trials.
► Decision theory could aid in making the risk-benefit evaluation explicit.
► Explicit evaluations allow for well-informed ethical justification process.
► Rationally defensible decisions result from well-informed ethical justification.