When research becomes practice: the concept of the therapeutic misconception and challenges to consent in clinical trials

Abstract

Many factors influence patients' decisions to participate in clinical trials. For many, the primary motivation is the possibility that they might derive some benefit from participation. This is particularly true for patients with limited treatment options, such as patients with advanced cancer. While this is not surprising, it is potentially problematic if patients fail to recognise the distinction between research and clinical care (a phenomenon known as the 'therapeutic misconception'). This is becoming increasingly problematic as clinical trial designs become more complex, as clinical trials become more embedded in routine clinical care, and as trials are increasingly used by patients and clinicians to access new diagnostic platforms and therapies. We outline some of these recent trends, focusing on the cancer clinical trials landscape as this provides a good case study of the phenomenon. We conclude by making preliminary suggestions that changes to the consent process, perhaps using 'dynamic consent' platforms, might help to mitigate the therapeutic misconception and note the need for further research to guide strategies for improving communication and decision-making.

Identifying locally actionable strategies to increase participant acceptability and feasibility to participate in Phase I cancer clinical trials

“…Similar to patients who participate in Phase I trials focusing on hope for a treatment benefit, 17 people with HNC in our study focused their comments on the safety and efficacy of the treatment as a deciding factor and suggested recruitment efforts focus on benefits to the participant. Especially considering that our participants received the explanation that a Phase I study ‘will be among a small number of participants to make sure the vaccine is safe’, consent practices for Phase I CCTs may need to adapt to mitigate therapeutic misconceptions 30 …”

“…Especially considering that our participants received the explanation that a Phase I study ‘will be among a small number of participants to make sure the vaccine is safe’, consent practices for Phase I CCTs may need to adapt to mitigate therapeutic misconceptions. 30 …”

“…Especially considering that our participants received the explanation that a Phase I study 'will be among a small number of participants to make sure the vaccine is safe', consent practices for Phase I CCTs may need to adapt to mitigate therapeutic misconceptions. 30 Thematic barriers identified including lack of physician under- 31 Other recommended options include providing transportation and childcare for participants to ease the burden of participation. 32,33 The additional efforts needed to recruit minoritized people with HNC to participate in our interviews mirror the additional efforts needed to recruit minoritized CCT participants.…”