MovDisordV3, PubMed, Corpus, bibRecord, 001B99

Launching invasive, first-in-human trials against Parkinson's disease: ethical considerations.

Identifieur interne : 001B99 ( PubMed/Corpus ); précédent : 001B98; suivant : 001C00

Launching invasive, first-in-human trials against Parkinson's disease: ethical considerations.

Auteurs : Jonathan Kimmelman ; Alex John London ; Bernard Ravina ; Tim Ramsay ; Mark Bernstein ; Alan Fine ; Frank W. Stahnisch ; Marina Elena Emborg

Source :

Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2009.

RBID : pubmed:19672990

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), Risk Assessment (ethics), Risk Assessment (methods), Risk Factors, Treatment Outcome.
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.

DOI: 10.1002/mds.22712
PubMed: 19672990

Links to Exploration step

pubmed:19672990

Le document en format XML

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<author><name sortKey="Kimmelman, Jonathan" sort="Kimmelman, Jonathan" uniqKey="Kimmelman J" first="Jonathan" last="Kimmelman">Jonathan Kimmelman</name>
<affiliation><nlm:affiliation>Biomedical Ethics Unit, Department of Social Studies of Medicine, McGill University, 3647 Peel Street, Montreal, QB H3A 1X1, Canada. jonathan.kimmelman@mcgill.ca</nlm:affiliation>
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<author><name sortKey="London, Alex John" sort="London, Alex John" uniqKey="London A" first="Alex John" last="London">Alex John London</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.</div>
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	Movement Disorders (revue)
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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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