MovDisordV3, Main, Exploration, bibRecord, 002237

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

Identifieur interne : 002237 ( Main/Exploration ); précédent : 002236; suivant : 002238

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

Auteurs : Jonathan Kimmelman [Canada, États-Unis] ; Alex John London [États-Unis] ; Bernard Ravina [États-Unis] ; Tim Ramsay [Canada] ; Mark Bernstein [Canada] ; Alan Fine [Canada] ; Frank W. Stahnisch [Canada] ; Marina Elena Emborg [États-Unis]

Source :

Movement Disorders [ 0885-3185 ] ; 2009-10-15.

RBID : ISTEX:901C65287578CBF9E6A0D989E0108FB4B922E8DE

English descriptors

KwdEn :
- Animals, Clinical Protocols, Clinical Trials as Topic (ethics), Clinical Trials as Topic (methods), Humans, Neurosurgical Procedures (ethics), Neurosurgical Procedures (methods), Parkinson Disease (therapy), Parkinson's disease, Risk Assessment (ethics), Risk Assessment (methods), Risk Factors, Treatment Outcome, clinical trials, phase 1, preclinical research, research ethics, translational research.
MESH :
- ethics : Clinical Trials as Topic, Neurosurgical Procedures, Risk Assessment.
- methods : Clinical Trials as Topic, Neurosurgical Procedures, Risk Assessment.
- therapy : Parkinson Disease.
- Animals, Clinical Protocols, Humans, Risk Factors, Treatment Outcome.

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

Url:

DOI: 10.1002/mds.22712

Affiliations:

Le document en format XML

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<author><name sortKey="Ravina, Bernard" sort="Ravina, Bernard" uniqKey="Ravina B" first="Bernard" last="Ravina">Bernard Ravina</name>
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<author><name sortKey="Ramsay, Tim" sort="Ramsay, Tim" uniqKey="Ramsay T" first="Tim" last="Ramsay">Tim Ramsay</name>
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<author><name sortKey="Bernstein, Mark" sort="Bernstein, Mark" uniqKey="Bernstein M" first="Mark" last="Bernstein">Mark Bernstein</name>
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<front><div type="abstract" xml:lang="en">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</div>
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Movement Disorders (revue)

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

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

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