Comparative effectiveness research

Comparative effectiveness research (CER) compares two or more already-in-use treatments (often FDA approved) to determine which is the most effective. Although most of this research is observational ('big data' research of medical records), CER can also involve head-to-head randomized clinical trials (RCTs). Drug companies have little incentive to conduct head-to-head trials. But such studies could be invaluable in keeping down overall health care costs. 

Since such studies involve treatments that are already used in clinical practice (i.e., they do not involve novel or experimental treatments with a lot of unknowns), some have argued that perhaps such studies add no additional risk beyond the risks of usual treatment.  Some have argued, based on this line of reasoning, that some CER studies do not even need informed consent.  I have doubts about this line of reasoning.

My work focuses on how to analyze research risks in CER RCTs, whether informed consent can be ethically waived in some CER RCTs, and when traditional written informed consent may be not only unnecessary but less than ideal.

Kim SYH, Miller FG.  Informed Consent for Pragmatic Trials: The Integrated Consent Model. New Eng J Medicine 2014; 370:769-72.

Kim SYH
, Miller FG. Varieties of standard-of-care treatment randomized trials: Ethical implications. JAMA. 2015;313(9):895-896.

Nayak RK, Wendler D, Miller FG, Kim SYH. PragmaticRandomized Trials Without Standard Informed Consent?: A National Survey.  Annals of Internal Medicine. 2015;163(5):356.
Comments