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.
Physicians who choose rural practice are called upon to deliver care that they have limited experience with, most notably in emergency situations when they are the most skilled people around.
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.
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.