The legal definition of a patient and the corresponding duties of the physician have been debated in state courts for over a century, and many aspects of the question are still unresolved.
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.
The picture that emerges from study of physician economic behavior is mixed, but from the intensity of responses by some professional societies to Medicare's coding modifier proposal, it appears that economic incentives matter a lot to many of their members.
This process of developing EBM-based guidelines and applying them to clinical care highlights the tension between generating unbiased knowledge based on statistical aggregation and the application of this information to individual patients.
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.