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

  1. Jonathan Kimmelman PhD1,*,
  2. Alex John London PhD2,
  3. Bernard Ravina MD3,
  4. Tim Ramsay PhD4,
  5. Mark Bernstein MD5,
  6. Alan Fine VMD, PhD6,
  7. Frank W. Stahnisch MD, PhD7,
  8. Marina Elena Emborg MD, PhD8,*

Article first published online: 11 AUG 2009

DOI: 10.1002/mds.22712

Issue

Movement Disorders

Movement Disorders

Volume 24, Issue 13, pages 1893–1901, 15 October 2009

Additional Information

How to Cite

Kimmelman, J., London, A. J., Ravina, B., Ramsay, T., Bernstein, M., Fine, A., Stahnisch, F. W. and Emborg, M. E. (2009), Launching invasive, first-in-human trials against Parkinson's disease: Ethical considerations. Movement Disorders, 24: 1893–1901. doi: 10.1002/mds.22712

Author Information

  1. 1

    Biomedical Ethics Unit, Department of Social Studies of Medicine, McGill University, Montreal, Quebec, Canada

  2. 2

    Department of Philosophy, Carnegie Mellon University, Pittsburgh, Pennsylvania, USA

  3. 3

    Department of Neurology, MIND Unit, University of Rochester School of Medicine, Rochester, New York, USA

  4. 4

    Ottawa Health Research Institute, The Ottawa Hospital, Ottawa, Ontario, Canada

  5. 5

    Division of Neurosurgery, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada

  6. 6

    Department of Physiology and Biophysics, Neuroscience Institute, Dalhousie University Faculty of Medicine, Halifax, Nova Scotia, Canada

  7. 7

    Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada

  8. 8

    Preclinical Parkinson's Research Program, Wisconsin National Primate Research Center and Department of Medical Physics, University of Wisconsin, Madison, Wisconsin, USA

*Biomedical Ethics Unit, Department of Social Studies of Medicine, McGill University, 3647 Peel Street, Montreal, QB H3A 1X1, Canada

  1. †

    Potential conflict of interest: Nothing to report.

Publication History

  1. Issue published online: 21 OCT 2009
  2. Article first published online: 11 AUG 2009
  3. Manuscript Accepted: 2 JUL 2009
  4. Manuscript Revised: 30 JUN 2009
  5. Manuscript Received: 12 DEC 2008

Funded by

  • Canadian Institutes of Health Research. Grant Number: NNF 80045
  • CIHR
  • NINDS
  • Andrew W. Mellon Foundation
  • CDC
  • Kinetics Foundation
  • M. J. Fox Foundation
  • Parkinson's Disease Foundation
  • NIH-RARC. Grant Number: RR000167
  • Health Canada
  • US EPA
  • Heart and Stroke Foundation of Canada
  • Canadian Institutes of Health Research
  • States of Mind: Emerging Issues in Neuroethics. Grant Number: NNF 80045

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Keywords:

  • research ethics;
  • clinical trials;
  • Parkinson's disease;
  • preclinical research;
  • translational research;
  • phase 1

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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