Bioethics. 2016 May 16. doi: 10.1111/bioe.12260. [Epub ahead of print]

Do we Know Whether Researchers and Reviewers are Estimating Risk and Benefit Accurately?

Hey SP, Kimmelman J.

Abstract

Accurate estimation of risk and benefit is integral to good clinical research planning, ethical review, and study implementation. Some commentators have argued that various actors in clinical research systems are prone to biased or arbitrary risk/benefit estimation. In this commentary, we suggest the evidence supporting such claims is very limited. Most prior work has imputed risk/benefit beliefs based on past behavior or goals, rather than directly measuring them. We describe an approach - forecast analysis - that would enable direct and effective measure of the quality of risk/benefit estimation. We then consider some objections and limitations to the forecasting approach.