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.
The physician who offers telemedicine services to out-of-state patients is subject to the laws of his or her home state and the remote patient’s state, so it is crucial to understand both.
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.
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 Moseley study found no significant difference between those in the arthroscopic lavage and debridement arm of the study and those in the sham surgery arm.
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.