The Editor’s Pick for our June 2014 issue is “The Risk-Escalation Model: A Principled Design Strategy for Early-Phase Trials,” by Spencer Phillips Hey and Jonathan Kimmelman.
In this paper, Hey and Kimmelman address the special ethical challenges researchers face during the early stages of a research program, in the face of radical uncertainty. In such early–phase trials, our normal techniques for balancing risks with potential benefits are not especially helpful, given our lack of knowledge of the impact of our interventions. Hey and Kimmelman defend a “risk-escalation” strategy, which calls for researchers to build up to the point where they are offering maximal benefit slowly, as uncertainty diminishes. They argue that this approach is more likely to sustain long-term drug development, avoid harm, and further the social goals of medicine.
Spencer Phillips Hey, PhD, is a postdoctoral fellow in Biomedical Ethics at McGill University and a member of the Studies in Translation, Ethics, and Medicine (STREAM) research group. He received his PhD in philosophy from the Rotman Institute of Philosophy at the University of Western Ontario.
Jonathan Kimmelman, PhD, is Associate Professor in Biomedical Ethics, Experimental Medicine, and Social Studies of Medicine at McGill University, and directs the Studies in Translation, Ethics, and Medicine (STREAM) research group.