Some commentators say comparative trials of FDA-approved drugs are overburdened by current Common Rule regulations and that researchers should not be required to obtain explicit consent for participation in the most innocuous of these trials.
Anne Drapkin Lyerly, MD, MA and Ruth R. Faden, PhD, MPH
Participation in a research study—in which there are rigorous standards and close monitoring—may be a safer context for the use of medications in pregnancy than the clinical setting, where the evidence base is lacking.
Students more familiar with the quantifiable knowledge taught in medical and premedical curricula become aware that this perspective is not the only or even the most comprehensive way to see health, illness, and healing.
In cost-effectiveness research, the cost of a medical intervention is reported as a dollar amount per quality-adjusted life year gained—the quality of health and the length of time over which the health state exists.
The FDA’s expanded access pathway allows patients with no other therapeutic options to request access to investigational agents, but manufacturers do not often grant it.
AMA J Ethics. 2015;17(12):1142-1146. doi:
10.1001/journalofethics.2015.17.12.stas1-1512.