Failing to understand the distinction between research and clinical care, and the likelihood of benefit from participation in clinical trials is referred to as the “therapeutic misconception.” As described in a manuscript by Heynemann et al appearing in the February 2024 issue of the journal Bioethics, four decades have passed since the phenomenon termed the ‘therapeutic misconception’ first was described in the context of evaluation of participants' understanding of a randomized controlled trial (RCT) of a psychotropic agent. These investigators indicate that clinical trials play a crucial role in generating evidence about health care interventions and improving outcomes for current and future patients. A concern for individual trial participants, however, is that inevitably there are trade-offs involved in clinical trial participation, given that trials traditionally have been designed to benefit future patient populations rather than to offer personalized care. The evolution of the clinical trials landscape, including greater integration of clinical trials into health care and development of novel trial methodologies, may reinforce the significance of the therapeutic misconception and other forms of misunderstanding while at the same time (paradoxically) challenging its salience.
Using cancer clinical trials as an example, the researchers describe how methodological changes in early- and late-phase clinical trial designs, as well as changes in the design and delivery of health care, have an impact upon the therapeutic misconception. They suggest that such changes provide an impetus to re-examine the ethics of clinical research, particularly in relation to trial access; participant selection; communication and consent; and role delineation. The central problem to which the therapeutic misconception draws attention is the conflation of clinical research with clinical care, two rather different enterprises with vastly different goals. Persistent conceptual challenges surrounding the therapeutic misconception and related misunderstandings are considered in the article. Next, some emerging and, as yet, unexamined implications for the therapeutic misconception with the evolution of clinical trial designs and the widespread movement towards seamless integration of clinical research into clinical care are highlighted . An intention is to deconstruct a well-recognized concept within research ethics, contextualize it in the modern clinical trials landscape, and offer some preliminary practical suggestions for operationalizing these ideas.