Therapeutic Misconception

An Overview of Therapeutic Misconception in Clinical Trials

Chrisanne Bugay

George Washington University

There are various fields in the world of medicine that can be confusing and overwhelming for the general population. Some people tend to mesh it all together and bypass the intricate complexities that distinguish one realm from another. In standard medical care, the motive of the physician is to assist the patient in obtaining optimal health. This is not the case in clinical research, as physicians serve as principal investigators with the intention of contributing to scientific knowledge in order to find new or improved interventions and pharmaceuticals that will aid in the alleviation or elimination of disease. In other words, the physician investigator acts in accordance with the trial protocol as opposed to what standard medical care would dictate.

There has been much deliberation and debate surrounding the precise definition of therapeutic misconception. Simply put, therapeutic misconception is the perceived notion that a trial subject will directly benefit from participating in a clinical trial, therefore overestimating benefits and possibly underestimating any risks involved. Henderson et al (2007) provides a very clear definition stating, “Therapeutic misconception exists when individuals do not understand that the defining purpose of clinical research is to produce generalizable knowledge, regardless of whether the subjects enrolled in the trial may potentially benefit from the intervention under study or from other aspects of the clinical trial.”

Therapeutic misconception can commonly be seen in randomized, double-blind, placebo controlled procedures and unfortunately in trials where patients are terminally ill and are in desperate hopes for a miracle cure. However, therapeutic misconception can also be experienced by investigators, site staff, and others involved in clinical trial experimentation. Once a...