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.

Miller, D. G., Kim, S. Y. H., Li, X., Dickert, N. W., Flory, J., Runge, C. P., & Relton, C. (2018). Ethical Acceptability of Postrandomization Consent in Pragmatic Clinical Trials.JAMA Network Open, 1(8), e186149. doi:10.1001/jamanetworkopen.2018.6149

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

, 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.

Kim SYH, Miller FG.  Ethical Complexities in Standard of Care Randomized Trials: A Case Study of MorningVersus Nighttime Dosing of Blood Pressure Drugs. Clinical Trials. 2015 doi: 10.1177/1740774515607213

Miller FG, Kim SYHPersonal Care in Learning Health Care SystemsKennedy Institute of Ethics Journal. Volume 25, Number 4, December 2015, pp. 419-435

Chen S, Kim SYHA Framework for Analysis of Research Risksand Benefits to Participants in Standard of Care Pragmatic Clinical Trials. Clinical Trials. doi: 10.1177/1740774516656945

Kalkman S, Kim SYH, van Thiel GJMW, Diederick E, Grobbee DE, van Delden JJM. Ethics of informed consent for pragmatic trials with new interventions. Value in Health. 2017.