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American Journal of Bioethics.

Randomized Trials are Deeply Offensive

In this issue, Macklin and Natanson examine some of the controversies that arise in randomized clinical trials (RCTs). They are particularly concerned that researchers may misrepresent novel interventions as “usual care.” This is problematic, they claim, both ethically and scientifically. Ethically, it misleads potential research participants into believing that studies have known and minimal risks. Scientifically, such studies may lead to erroneous conclusions about the relative efficacy of specific practices.

Implicit in their critique are two ideas. The first is that we can know what “usual care” is. Their definition, however, is both broad and vague. They write, “(P)hysicians must use clinical judgment in choosing a treatment and varying or changing an aspect of the treatment as the condition of seriously ill patients fluctuates. Such clinical judgments can be based on shared clinical experience over time in the field, as well as on the current literature, including preclinical studies. In addition, physicians in clinical practice often use physiological endpoints that are based on the accepted scientific aspects of physiology.” In other words, usual care can only be defined by considering many different sources.

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Volume 20, Issue 1
January 2020

Target Articles.

Ethics and Collateral Findings in Pragmatic Clinical Trials Stephanie R. Morain, Kevin Weinfurt, Juli Bollinger, Gail Geller, Debra JH Mathews & Jeremy Sugarman