Therapeutic misunderstandings in modern research.

Clinical trials play a crucial role in generating evidence about healthcare interventions and improving outcomes for current and future patients. For individual trial participants, however, there are inevitably trade‐offs involved in clinical trial participation, given that trials have traditionally...

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Published in:Bioethics Vol. 38; no. 2; pp. 138 - 153
Main Authors: Heynemann, Sarah, Lipworth, Wendy, McLachlan, Sue‐Anne, Philip, Jennifer, John, Tom, Kerridge, Ian
Format: Article
Published: Wiley-Blackwell Feb2024
Subjects:
Online Access:View this record in EBSCOhost
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      pub: Wiley-Blackwell
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        10.1111/bioe.13241
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        atl: Therapeutic misunderstandings in modern research.
      aug:
        au:
          Heynemann, Sarah
          Lipworth, Wendy
          McLachlan, Sue‐Anne
          Philip, Jennifer
          John, Tom
          Kerridge, Ian
        affil:
          Sydney Health Ethics, Faculty of Medicine and Health, The University of Sydney, Sydney New South Wales,, Australia
          Department of Philosophy, Macquarie University, Sydney New South Wales,, Australia
          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
          Department of Palliative Care, St Vincent's Hospital, Melbourne Victoria,, Australia
          Department of Palliative Care, Peter MacCallum Cancer Centre, Melbourne Victoria,, Australia
          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
          Haematology Department, Royal North Shore Hospital, Sydney New South Wales,, Australia
      su:
        Occupational roles
        Human research subjects
        Clinical trials
        Research ethics
        Informed consent (Medical law)
        Communication
        Bioethics
        Patient selection
        Research methodology
        Tumors
      sug:
        subj:
          Occupational roles
          Human research subjects
          Clinical trials
          Research ethics
          Informed consent (Medical law)
          Communication
          Bioethics
          Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
          Patient selection
          Research methodology
          Tumors
      keyword:
        adaptive clinical trial
        Bayes theorem
        clinical trials
        informed consent
        research ethics
        therapeutic misconception
        adaptive clinical trial
        Bayes theorem
        clinical trials
        informed consent
        research ethics
        therapeutic misconception
      ab: Clinical trials play a crucial role in generating evidence about healthcare interventions and improving outcomes for current and future patients. For individual trial participants, however, there are inevitably trade‐offs involved in clinical trial participation, given that trials have traditionally been designed to benefit future patient populations rather than to offer personalised care. Failure to understand the distinction between research and clinical care and the likelihood of benefit from participation in clinical trials has been termed the 'therapeutic misconception'. The evolution of the clinical trials landscape, including greater integration of clinical trials into healthcare 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 exemplar, we describe how methodological changes in early‐ and late‐phase clinical trial designs, as well as changes in the design and delivery of healthcare, impact upon the therapeutic misconception. We suggest that this provides an impetus to re‐examine the ethics of clinical research, particularly in relation to trial access, participant selection, communication and consent, and role delineation.
      pubtype: Academic Journal
      doctype: Article
      src: R
    language: English
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