Physician-investigators face a fundamental conflict between seeking the best care for their individual patients and conducting the highest quality clinical research, said Robert Truog, HMS professor of medical ethics in the Department of Global Health and Social Medicine and of anesthesia (pediatrics) at Children’s Hospital Boston.
The strategies to manage the conflicting obligations may do more to showcase the ethical tensions than resolve them, Truog said in a March 9 talk on ethical conflicts in randomized controlled trials during the Harvard Catalyst Colloquium Series.
Physician ambivalence about their role as healers or investigators may result in letting patients have access to the unproven experimental treatment, especially in life-saving protocols. Randomized controlled clinical trials are almost always the best approach for evaluating new therapies, but alternatives may be a better ethical choice in some cases, such as compelling data from observational studies.
In another approach, nontraditional ways of randomizing research participants may balance conflicting obligations and ease psychological burdens, he said. For example, he discussed a trial design for an invasive but potentially life-saving device for newborns with persistent pulmonary hypertension, which ran 50/50 randomization until four deaths accumulated in one arm of the study. Then all patients received the most successful arm, which was the experimental device in this case.
