Comparative effectiveness studies have become increasingly common in recent years. Such studies contain at least one group of participants who receive “usual care,” defined as the current treatment used in the ordinary course of care. When properly designed, comparative effectiveness studies can improve patient care by identifying whether new interventions provide benefits or instead pose risks.
In a study published online on January 2 in the American Journal of Bioethics, co-authors, Ruth Macklin, Ph.D., and Charles Natanson, M.D., analyzed three major comparative effectiveness trials published in The New England Journal of Medicine and found significant ethical lapses. What the three studies defined as “usual care” did not accurately represent current clinical practice. This problem not only leads to inaccurate trial results but can endanger future patients to whom the studies’ erroneous findings are applied. In addition, trial subjects were given informed consent forms that falsely described novel interventions as usual care and misled subjects into believing that the risks posed by the interventions were known.
These findings challenge the widespread belief that randomized trials that include “usual care” are safe and show that comparative effectiveness studies need better oversight by sponsors and Institutional Review Boards. Dr. Macklin is distinguished university professor emerita in the department of epidemiology & population health at Einstein. Dr. Natanson is senior investigator at the National Institutes of Health.
Posted on: Monday, January 06, 2020