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Launching invasive, first-in-human trials against Parkinson's disease: Ethical considerations

Authors

  • Jonathan Kimmelman PhD,

    Corresponding author
    1. Biomedical Ethics Unit, Department of Social Studies of Medicine, McGill University, Montreal, Quebec, Canada
    • Biomedical Ethics Unit, Department of Social Studies of Medicine, McGill University, 3647 Peel Street, Montreal, QB H3A 1X1, Canada
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  • Alex John London PhD,

    1. Department of Philosophy, Carnegie Mellon University, Pittsburgh, Pennsylvania, USA
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  • Bernard Ravina MD,

    1. Department of Neurology, MIND Unit, University of Rochester School of Medicine, Rochester, New York, USA
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  • Tim Ramsay PhD,

    1. Ottawa Health Research Institute, The Ottawa Hospital, Ottawa, Ontario, Canada
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  • Mark Bernstein MD,

    1. Division of Neurosurgery, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada
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  • Alan Fine VMD, PhD,

    1. Department of Physiology and Biophysics, Neuroscience Institute, Dalhousie University Faculty of Medicine, Halifax, Nova Scotia, Canada
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  • Frank W. Stahnisch MD, PhD,

    1. Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada
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  • Marina Elena Emborg MD, PhD

    Corresponding author
    1. Preclinical Parkinson's Research Program, Wisconsin National Primate Research Center and Department of Medical Physics, University of Wisconsin, Madison, Wisconsin, USA
    • Preclinical Parkinson's Research Program, Wisconsin National Primate Research Center and Department of Medical Physics, University of Wisconsin, Madison, 1220 Capitol Court, Madison, WI 53705
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  • Potential conflict of interest: Nothing to report.

Abstract

The decision to initiate invasive, first-in-human trials involving Parkinson's disease presents a vexing ethical challenge. Such studies present significant surgical risks, and high degrees of uncertainty about intervention risks and biological effects. We argue that maintaining a favorable risk-benefit balance in such circumstances requires a higher than usual degree of confidence that protocols will lead to significant direct and/or social benefits. One critical way of promoting such confidence is through the application of stringent evidentiary standards for preclinical studies. We close with a series of recommendations for strengthening the internal and external validity of preclinical studies, reducing their tendency toward optimism and publication biases, and improving the knowledge base used to design and evaluate preclinical studies. © 2009 Movement Disorder Society

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