MovDisordV3, Main, Exploration, bibRecord, 001020

Prerequisites to Launch Neuroprotective Trials in Parkinson's Disease: An Industry Perspective

Identifieur interne : 001020 ( Main/Exploration ); précédent : 001019; suivant : 001021

Prerequisites to Launch Neuroprotective Trials in Parkinson's Disease: An Industry Perspective

Auteurs : Johannes R. Streffer [États-Unis] ; Igor D. Grachev [États-Unis] ; Cheryl Fitzer-Attas [Israël] ; Baltazar Gomez-Mancilla [Suisse] ; Babak Boroojerdi [Allemagne] ; Juliana Bronzova [Pays-Bas] ; Susanne Ostrowitzki [Suisse] ; Stephen J. Victor [États-Unis] ; Paulo Fontoura [Suisse] ; Robert Alexander [Suède]

Source :

Movement disorders [ 0885-3185 ] ; 2012.

RBID : Pascal:12-0223362

Descripteurs français

Pascal (Inist)
- Maladie de Parkinson, Pathologie du système nerveux, Industrie, Essai clinique.

English descriptors

KwdEn :
- Clinical trial, Industry, Nervous system diseases, Parkinson disease.

Abstract

Realizing that 60% to 80% of dopaminergic nigrostriatal neurons are nonfunctional at the time of clinical diagnosis, there is an emerging consensus that disease-modifying treatments should be initiated in the earliest stages of Parkinson's disease (PD). To date, clinical trial designs and metrics in PD have been focused on motor symptoms as the core feature of the clinical disease. To identify earlier or "pre-motor" populations in PD, new markers have been proposed. We address the prerequisites needed to use these pre-motor markers in clinical trials for the selection of subjects, definition of populations, and monitoring of disease progression. This may require the development of new diagnostic criteria potentially based on non-motor clinical signs, imaging techniques, or biological features, all requiring discussion in a regulatory framework. Questions addressed include: Which steps must be taken to gain a broad consensus in the field from academic opinion leaders, patient advocacy groups, regulatory bodies, and industry? How do we prevent the selection of subgroups, which may not be representative of the full disease spectrum? Is there a way forward in personalized medicine? How do we balance risk and benefit in an at-risk population? While many tools are available, a concerted effort is required to develop integrated data sets, as well as to achieve the necessary standardization for multicenter clinical trials. To this end, public-private consortia (including academic centers, patient advocacy groups, and industry) will be of crucial importance to prospectively investigate and define the best tools and treatment paradigms.

Affiliations:

Allemagne, Israël, Pays-Bas, Suisse, Suède, États-Unis
New Jersey

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Le document en format XML

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<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Pharma Research and Early Development, Neuroscience DTA, Roche Pharmaceuticals</s1>
<s2>Basel</s2>
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<author><name sortKey="Alexander, Robert" sort="Alexander, Robert" uniqKey="Alexander R" first="Robert" last="Alexander">Robert Alexander</name>
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<series><title level="j" type="main">Movement disorders</title>
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<imprint><date when="2012">2012</date>
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<front><div type="abstract" xml:lang="en">Realizing that 60% to 80% of dopaminergic nigrostriatal neurons are nonfunctional at the time of clinical diagnosis, there is an emerging consensus that disease-modifying treatments should be initiated in the earliest stages of Parkinson's disease (PD). To date, clinical trial designs and metrics in PD have been focused on motor symptoms as the core feature of the clinical disease. To identify earlier or "pre-motor" populations in PD, new markers have been proposed. We address the prerequisites needed to use these pre-motor markers in clinical trials for the selection of subjects, definition of populations, and monitoring of disease progression. This may require the development of new diagnostic criteria potentially based on non-motor clinical signs, imaging techniques, or biological features, all requiring discussion in a regulatory framework. Questions addressed include: Which steps must be taken to gain a broad consensus in the field from academic opinion leaders, patient advocacy groups, regulatory bodies, and industry? How do we prevent the selection of subgroups, which may not be representative of the full disease spectrum? Is there a way forward in personalized medicine? How do we balance risk and benefit in an at-risk population? While many tools are available, a concerted effort is required to develop integrated data sets, as well as to achieve the necessary standardization for multicenter clinical trials. To this end, public-private consortia (including academic centers, patient advocacy groups, and industry) will be of crucial importance to prospectively investigate and define the best tools and treatment paradigms.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Israël</li>
<li>Pays-Bas</li>
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<name sortKey="Grachev, Igor D" sort="Grachev, Igor D" uniqKey="Grachev I" first="Igor D." last="Grachev">Igor D. Grachev</name>
<name sortKey="Victor, Stephen J" sort="Victor, Stephen J" uniqKey="Victor S" first="Stephen J." last="Victor">Stephen J. Victor</name>
</country>
<country name="Israël"><noRegion><name sortKey="Fitzer Attas, Cheryl" sort="Fitzer Attas, Cheryl" uniqKey="Fitzer Attas C" first="Cheryl" last="Fitzer-Attas">Cheryl Fitzer-Attas</name>
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<country name="Suisse"><noRegion><name sortKey="Gomez Mancilla, Baltazar" sort="Gomez Mancilla, Baltazar" uniqKey="Gomez Mancilla B" first="Baltazar" last="Gomez-Mancilla">Baltazar Gomez-Mancilla</name>
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<name sortKey="Fontoura, Paulo" sort="Fontoura, Paulo" uniqKey="Fontoura P" first="Paulo" last="Fontoura">Paulo Fontoura</name>
<name sortKey="Ostrowitzki, Susanne" sort="Ostrowitzki, Susanne" uniqKey="Ostrowitzki S" first="Susanne" last="Ostrowitzki">Susanne Ostrowitzki</name>
</country>
<country name="Allemagne"><noRegion><name sortKey="Boroojerdi, Babak" sort="Boroojerdi, Babak" uniqKey="Boroojerdi B" first="Babak" last="Boroojerdi">Babak Boroojerdi</name>
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<country name="Pays-Bas"><noRegion><name sortKey="Bronzova, Juliana" sort="Bronzova, Juliana" uniqKey="Bronzova J" first="Juliana" last="Bronzova">Juliana Bronzova</name>
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<country name="Suède"><noRegion><name sortKey="Alexander, Robert" sort="Alexander, Robert" uniqKey="Alexander R" first="Robert" last="Alexander">Robert Alexander</name>
</noRegion>
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</record>

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	Movement Disorders (revue)
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Movement Disorders (revue)

Prerequisites to Launch Neuroprotective Trials in Parkinson's Disease: An Industry Perspective

Prerequisites to Launch Neuroprotective Trials in Parkinson's Disease: An Industry Perspective

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri