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.
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.
Thomas W. LeBlanc, MD, MA, MHS and Arif H. Kamal, MD, MBA, MHS
Clinical trials should assess patients’ distress and test interventions to address it, just as they assess adverse events and test novel therapeutic agents.
AMA J Ethics. 2017;19(5):460-466. doi:
10.1001/journalofethics.2017.19.5.stas1-1705.