Date of Original Version

8-2009

Type

Article

Published In

Movement Disorders Vol. 24, No. 13, 2009, pp. 1893–1901

Rights Management

All Rights Reserved

Abstract or Description

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 riskbenefit 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.

DOI

10.1002/mds.22712

Included in

Philosophy Commons

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