The Clinical Trials Research Group (CTRG) of the Biomedical Ethics Unit at McGill University is a research team dedicated to investigating ethical and legal questions in human research. For more information see the About us section.
Clinical Trials Research Group
Biomedical Ethics Unit
3647 Peel Street
Montreal, Quebec H3A 1X1
audrey.prosser [at] mcgill.ca (Email)
CTRG Seminar Series
Biomedical Ethics Unit, Faculty of Medicine
Therapeutic Overestimation in Early-Phase Clinical Research
Nancy M. P. King,
JD Professor, Dept. of Social Science & Health Policy
Director Program in Bioethics, Health and Society
Wake Forest University , School of Medicine
Friday, April 25, 2008
11:00 a.m. – 1:00 p.m.
3647 Peel Street, Room 101
For information call 514 398-6980
Much scholarly attention has been paid to the therapeutic misconception (TM) in clinical trials, but there are almost as many definitions of TM as there are articles about it. Most recently, there have been a number of different attempts to refine and clarify the definition of TM, in order to measure it meaningfully. This new scholarship distinguishes classic TM –that is, mistakenly considering research to be treatment -- from similar errors in understanding the implications of research participation. Errors involving the overestimation of direct benefit and the underestimation of risks of harm from research participation, have been called “therapeutic misestimation” or “therapeutic optimism.” I use the term “therapeutic overestimation” (TO) to emphasize that such errors affect the expectation of direct benefit. If TO is not TM, then what is it? Whatever it is, is it a problem? And if it is a problem, what should – and can – be done about it? Like most of the recent literature on TM, my examination of TO focuses on early-phase research, rather than on RCTs, where TM was first identified.