Designing Clinical Trials for Dystonia
Identifieur interne : 000E10 ( Main/Exploration ); précédent : 000E09; suivant : 000E11Designing Clinical Trials for Dystonia
Auteurs : Wendy R. Galpern [États-Unis] ; Christopher S. Coffey [États-Unis] ; Alberto Albanese [Italie] ; Ken Cheung [États-Unis] ; Cynthia L. Comella [États-Unis] ; Dixie J. Ecklund [États-Unis] ; Stanley Fahn [États-Unis] ; Joseph Jankovic [États-Unis] ; Karl Kieburtz [États-Unis] ; Anthony E. Lang [Canada] ; Michael P. Mcdermott [États-Unis] ; Jeremy M. Shefner [États-Unis] ; Jan K. Teller [États-Unis] ; John L. P. Thompson [États-Unis] ; Sharon D. Yeatts [États-Unis] ; H. A. Jinnah [États-Unis]Source :
- Neurotherapeutics [ 1933-7213 ] ; 2013.
Abstract
With advances in the understanding of the pathophysiology of dystonia, novel therapeutics are being developed. Such therapies will require clinical investigation ranging from exploratory studies to examine safety, tolerability, dosage selection, and preliminary efficacy to confirmatory studies to evaluate efficacy definitively. As dystonia is a rare and complex disorder with clinical and etiological heterogeneity, clinical trials will require careful consideration of the trial design, including enrollment criteria, concomitant medication use, and outcome measures. Given the complexities of designing and implementing efficient clinical trials, it is important for clinicians and statisticians to collaborate closely throughout the clinical development process and that each has a basic understanding of both the clinical and statistical issues that must be addressed. To facilitate designing appropriate clinical trials in this field, we review important general clinical trial and regulatory principles, and discuss the critical components of trials with an emphasis on considerations specific to dystonia. Additionally, we discuss designs used in early exploratory, late exploratory, and confirmatory phases, including adaptive designs.
The online version of this article (doi:10.1007/s13311-013-0221-6) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1007/s13311-013-0221-6
PubMed: 24282121
PubMed Central: 3899487
Affiliations:
- Canada, Italie, États-Unis
- Caroline du Sud, Géorgie (États-Unis), Illinois, Iowa, Lombardie, Maryland, Texas, État de New York
- Houston, Milan
- Baylor College of Medicine
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Le document en format XML
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Galpern</name><affiliation wicri:level="2"><nlm:aff id="Aff1">National Institute of Neurological Disorders and Stroke, National Institutes of Health, 6001 Executive Blvd., Rm 2225, Bethesda, MD 20892 USA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Maryland</region></placeName><wicri:cityArea>National Institute of Neurological Disorders and Stroke, National Institutes of Health, 6001 Executive Blvd., Rm 2225, Bethesda</wicri:cityArea></affiliation></author><author><name sortKey="Coffey, Christopher S" sort="Coffey, Christopher S" uniqKey="Coffey C" first="Christopher S." last="Coffey">Christopher S. Coffey</name><affiliation wicri:level="2"><nlm:aff id="Aff2">Clinical Trials Statistical & Data Management Center, University of Iowa, Iowa City, IA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Iowa</region></placeName><wicri:cityArea>Clinical Trials Statistical & Data Management Center, University of Iowa, Iowa City</wicri:cityArea></affiliation></author><author><name sortKey="Albanese, Alberto" sort="Albanese, Alberto" uniqKey="Albanese A" first="Alberto" last="Albanese">Alberto Albanese</name><affiliation wicri:level="3"><nlm:aff id="Aff3">Department of Neurology, Catholic University and Carlo Besta National Neurological Institute, Milan, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Neurology, Catholic University and Carlo Besta National Neurological Institute, Milan</wicri:regionArea><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Cheung, Ken" sort="Cheung, Ken" uniqKey="Cheung K" first="Ken" last="Cheung">Ken Cheung</name><affiliation wicri:level="2"><nlm:aff id="Aff4">Department of Biostatistics, Columbia University, New York, NY USA</nlm:aff><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>Department of Biostatistics, Columbia University, New York</wicri:cityArea></affiliation></author><author><name sortKey="Comella, Cynthia L" sort="Comella, Cynthia L" uniqKey="Comella C" first="Cynthia L." last="Comella">Cynthia L. Comella</name><affiliation wicri:level="2"><nlm:aff id="Aff5">Rush University Medical Center, Chicago, IL USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>Rush University Medical Center, Chicago</wicri:cityArea></affiliation></author><author><name sortKey="Ecklund, Dixie J" sort="Ecklund, Dixie J" uniqKey="Ecklund D" first="Dixie J." last="Ecklund">Dixie J. Ecklund</name><affiliation wicri:level="2"><nlm:aff id="Aff2">Clinical Trials Statistical & Data Management Center, University of Iowa, Iowa City, IA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Iowa</region></placeName><wicri:cityArea>Clinical Trials Statistical & Data Management Center, University of Iowa, Iowa City</wicri:cityArea></affiliation></author><author><name sortKey="Fahn, Stanley" sort="Fahn, Stanley" uniqKey="Fahn S" first="Stanley" last="Fahn">Stanley Fahn</name><affiliation wicri:level="2"><nlm:aff id="Aff6">Movement Disorder Division, Neurological Institute, Columbia University, New York, NY USA</nlm:aff><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>Movement Disorder Division, Neurological Institute, Columbia University, New York</wicri:cityArea></affiliation></author><author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name><affiliation wicri:level="2"><nlm:aff id="Aff7">Parkinson’s Disease Center and Movement Disorders Clinic, Department of Neurology, Baylor College of Medicine, Houston, TX USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Parkinson’s Disease Center and Movement Disorders Clinic, Department of Neurology, Baylor College of Medicine, Houston</wicri:cityArea><placeName><settlement type="city">Houston</settlement><region type="state">Texas</region></placeName><orgName type="university" n="3">Baylor College of Medicine</orgName></affiliation></author><author><name sortKey="Kieburtz, Karl" sort="Kieburtz, Karl" uniqKey="Kieburtz K" first="Karl" last="Kieburtz">Karl Kieburtz</name><affiliation wicri:level="2"><nlm:aff id="Aff8">Center for Human Experimental Therapeutics, University of Rochester Medical Center, Rochester, NY USA</nlm:aff><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>Center for Human Experimental Therapeutics, University of Rochester Medical Center, Rochester</wicri:cityArea></affiliation></author><author><name sortKey="Lang, Anthony E" sort="Lang, Anthony E" uniqKey="Lang A" first="Anthony E." last="Lang">Anthony E. Lang</name><affiliation wicri:level="1"><nlm:aff id="Aff9">Morton and Gloria Shulman Movement Disorders Clinic and the Edmond J. Safra Program in Parkinson’s Disease, Toronto Western Hospital, Toronto, Canada</nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Morton and Gloria Shulman Movement Disorders Clinic and the Edmond J. Safra Program in Parkinson’s Disease, Toronto Western Hospital, Toronto</wicri:regionArea><wicri:noRegion>Toronto</wicri:noRegion></affiliation></author><author><name sortKey="Mcdermott, Michael P" sort="Mcdermott, Michael P" uniqKey="Mcdermott M" first="Michael P." last="Mcdermott">Michael P. Mcdermott</name><affiliation wicri:level="2"><nlm:aff id="Aff10">Department of Biostatistics and Computational Biology and Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, NY USA</nlm:aff><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>Department of Biostatistics and Computational Biology and Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester</wicri:cityArea></affiliation></author><author><name sortKey="Shefner, Jeremy M" sort="Shefner, Jeremy M" uniqKey="Shefner J" first="Jeremy M." last="Shefner">Jeremy M. Shefner</name><affiliation wicri:level="2"><nlm:aff id="Aff11">Department of Neurology, Upstate Medical University, Syracuse, NY USA</nlm:aff><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>Department of Neurology, Upstate Medical University, Syracuse</wicri:cityArea></affiliation></author><author><name sortKey="Teller, Jan K" sort="Teller, Jan K" uniqKey="Teller J" first="Jan K." last="Teller">Jan K. Teller</name><affiliation wicri:level="2"><nlm:aff id="Aff12">Dystonia Medical Research Foundation, Chicago, IL USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>Dystonia Medical Research Foundation, Chicago</wicri:cityArea></affiliation></author><author><name sortKey="Thompson, John L P" sort="Thompson, John L P" uniqKey="Thompson J" first="John L. P." last="Thompson">John L. P. Thompson</name><affiliation wicri:level="2"><nlm:aff id="Aff4">Department of Biostatistics, Columbia University, New York, NY USA</nlm:aff><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>Department of Biostatistics, Columbia University, New York</wicri:cityArea></affiliation></author><author><name sortKey="Yeatts, Sharon D" sort="Yeatts, Sharon D" uniqKey="Yeatts S" first="Sharon D." last="Yeatts">Sharon D. Yeatts</name><affiliation wicri:level="2"><nlm:aff id="Aff13">Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Caroline du Sud</region></placeName><wicri:cityArea>Department of Public Health Sciences, Medical University of South Carolina, Charleston</wicri:cityArea></affiliation></author><author><name sortKey="Jinnah, H A" sort="Jinnah, H A" uniqKey="Jinnah H" first="H. A." last="Jinnah">H. A. Jinnah</name><affiliation wicri:level="2"><nlm:aff id="Aff14">Department of Neurology, Human Genetics & Pediatrics, Emory University, Atlanta, GA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Géorgie (États-Unis)</region></placeName><wicri:cityArea>Department of Neurology, Human Genetics & Pediatrics, Emory University, Atlanta</wicri:cityArea></affiliation></author></analytic><series><title level="j">Neurotherapeutics</title><idno type="ISSN">1933-7213</idno><idno type="eISSN">1878-7479</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>With advances in the understanding of the pathophysiology of dystonia, novel therapeutics are being developed. Such therapies will require clinical investigation ranging from exploratory studies to examine safety, tolerability, dosage selection, and preliminary efficacy to confirmatory studies to evaluate efficacy definitively. As dystonia is a rare and complex disorder with clinical and etiological heterogeneity, clinical trials will require careful consideration of the trial design, including enrollment criteria, concomitant medication use, and outcome measures. Given the complexities of designing and implementing efficient clinical trials, it is important for clinicians and statisticians to collaborate closely throughout the clinical development process and that each has a basic understanding of both the clinical and statistical issues that must be addressed. To facilitate designing appropriate clinical trials in this field, we review important general clinical trial and regulatory principles, and discuss the critical components of trials with an emphasis on considerations specific to dystonia. Additionally, we discuss designs used in early exploratory, late exploratory, and confirmatory phases, including adaptive designs.</p><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1007/s13311-013-0221-6) contains supplementary material, which is available to authorized users.</p></sec></div></front></TEI><affiliations><list><country><li>Canada</li><li>Italie</li><li>États-Unis</li></country><region><li>Caroline du Sud</li><li>Géorgie (États-Unis)</li><li>Illinois</li><li>Iowa</li><li>Lombardie</li><li>Maryland</li><li>Texas</li><li>État de New York</li></region><settlement><li>Houston</li><li>Milan</li></settlement><orgName><li>Baylor College of Medicine</li></orgName></list><tree><country name="États-Unis"><region name="Maryland"><name sortKey="Galpern, Wendy R" sort="Galpern, Wendy R" uniqKey="Galpern W" first="Wendy R." last="Galpern">Wendy R. Galpern</name></region><name sortKey="Cheung, Ken" sort="Cheung, Ken" uniqKey="Cheung K" first="Ken" last="Cheung">Ken Cheung</name><name sortKey="Coffey, Christopher S" sort="Coffey, Christopher S" uniqKey="Coffey C" first="Christopher S." last="Coffey">Christopher S. Coffey</name><name sortKey="Comella, Cynthia L" sort="Comella, Cynthia L" uniqKey="Comella C" first="Cynthia L." last="Comella">Cynthia L. Comella</name><name sortKey="Ecklund, Dixie J" sort="Ecklund, Dixie J" uniqKey="Ecklund D" first="Dixie J." last="Ecklund">Dixie J. Ecklund</name><name sortKey="Fahn, Stanley" sort="Fahn, Stanley" uniqKey="Fahn S" first="Stanley" last="Fahn">Stanley Fahn</name><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name><name sortKey="Jinnah, H A" sort="Jinnah, H A" uniqKey="Jinnah H" first="H. A." last="Jinnah">H. A. Jinnah</name><name sortKey="Kieburtz, Karl" sort="Kieburtz, Karl" uniqKey="Kieburtz K" first="Karl" last="Kieburtz">Karl Kieburtz</name><name sortKey="Mcdermott, Michael P" sort="Mcdermott, Michael P" uniqKey="Mcdermott M" first="Michael P." last="Mcdermott">Michael P. Mcdermott</name><name sortKey="Shefner, Jeremy M" sort="Shefner, Jeremy M" uniqKey="Shefner J" first="Jeremy M." last="Shefner">Jeremy M. Shefner</name><name sortKey="Teller, Jan K" sort="Teller, Jan K" uniqKey="Teller J" first="Jan K." last="Teller">Jan K. Teller</name><name sortKey="Thompson, John L P" sort="Thompson, John L P" uniqKey="Thompson J" first="John L. P." last="Thompson">John L. P. Thompson</name><name sortKey="Yeatts, Sharon D" sort="Yeatts, Sharon D" uniqKey="Yeatts S" first="Sharon D." last="Yeatts">Sharon D. Yeatts</name></country><country name="Italie"><region name="Lombardie"><name sortKey="Albanese, Alberto" sort="Albanese, Alberto" uniqKey="Albanese A" first="Alberto" last="Albanese">Alberto Albanese</name></region></country><country name="Canada"><noRegion><name sortKey="Lang, Anthony E" sort="Lang, Anthony E" uniqKey="Lang A" first="Anthony E." last="Lang">Anthony E. Lang</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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