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When research becomes practice: the concept of the therapeutic misconception and challenges to consent in clinical trials |
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| Authors: | Sarah Heynemann Wendy Lipworth Sue-Anne McLachlan Jennifer Philip Tom John Ian Kerridge |
| Affiliation: | 1. Sydney Health Ethics, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia;2. Department of Philosophy, Macquarie University, New South Wales, Sydney, Australia;3. Department of Medical Oncology, St Vincent's Hospital, Melbourne, Victoria, Australia Department of Medicine, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, Victoria, Australia;4. Department of Medicine, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, Victoria, Australia;5. Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia Sir Peter MacCallum Department of Medical Oncology, The University of Melbourne, Melbourne, Victoria, Australia;6. Sydney Health Ethics, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia Department of Philosophy, Macquarie University, New South Wales, Sydney, Australia Haematology Department, Royal North Shore Hospital, Sydney, New South Wales, Australia |
| 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. |
| Keywords: | clinical trial therapeutic misconception therapeutic misestimation informed consent research ethics adaptive clinical trial |