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

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