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.
Surgery’s unique characteristics, including difficulties in standardizing, blinding, and recruiting participants for clinical trials, render problematic the application of evidence-based standards to surgery.
Despite industry regulations for pharmaceutical speaker programming at restaurants, pharmaceutical representatives, compliance companies, and restaurants lack incentives for ensuring compliance with guidelines.
AMA J Ethics. 2015;17(8):787-795. doi:
10.1001/journalofethics.2015.17.8.sect1-1508.
Clinical equipoise—the idea that the community of medical experts is uncertain about the relative therapeutic merits of the arms of a clinical trial at its outset—mitigates physicians’ responsibility for patients’ poor outcomes when patients are assigned to the control arm or are harmed by an investigational agent.
AMA J Ethics. 2015;17(12):1108-1115. doi:
10.1001/journalofethics.2015.17.12.ecas1-1512.