Launching invasive, first-in-human trials against Parkinson's disease: ethical considerations.
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.
Kimmelman
Jonathan
J
Biomedical Ethics Unit, Department of Social Studies of Medicine, McGill University, 3647 Peel Street, Montreal, QB H3A 1X1, Canada. jonathan.kimmelman@mcgill.ca
London
Alex John
AJ
Ravina
Bernard
B
Ramsay
Tim
T
Bernstein
Mark
M
Fine
Alan
A
Stahnisch
Frank W
FW
Emborg
Marina Elena
ME
D000818:Animals; D002985:Clinical Protocols; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000379:methods*; D006801:Humans; D019635:Neurosurgical Procedures / Q000941:ethics / Q000379:methods; D010300:Parkinson Disease / Q000628:therapy*; D018570:Risk Assessment / Q000941:ethics / Q000379:methods; D012307:Risk Factors; D016896:Treatment Outcome