The Ethics of Evidence: Social Value and Clinical Trial Design

In order for clinical research on human subjects to be ethical, it must be socially valuable. A clinical trial that investigates a trivial or uninteresting question, or that merely reproduces already established research, is unethical because it does not promise any benefit, either to the subjects of the trial or to the general population. The primary objective of this project is to critically examine whether current clinical research is as socially valuable as it ought to be. Recent evidence indicates that Canadian clinical researchers tend to perform clinical trials that are explanatory, rather than pragmatic, in design. Because explanatory trials test hypotheses under "ideal" conditions, they are often not well suited to providing guidance on decisions made in clinical care contexts. In other words, explanatory trials appear to investigate questions that are of indirect social value. Pragmatic trials, which test hypotheses under "usual" conditions, are more likely to be immediately applicable to practice. Yet even though pragmatic trials appear to have direct social value they are infrequently carried out. At first glance, the preference for explanatory over pragmatic trials appears to be in tension with a general ethical commitment to research of high social value. In this project I consider whether a general assessment might be made of the relative social value of different types of clinical research trials. In pursuit of this objective I will investigate the ethical grounds for the social value criterion and the scope of the criterion in light of the other requirements of ethical clinical research, as well as the arguments offered for and against pragmatic trials. This project has the potential to have a significant impact on research policy in Canada, and consequently on the quality and relevance of research evidence translated into clinical practice.