The promise of futility trials in neurological diseases.
Identifieur interne : 000493 ( Main/Exploration ); précédent : 000492; suivant : 000494The promise of futility trials in neurological diseases.
Auteurs : Marcus W. Koch [Canada] ; Lawrence Korngut [Canada] ; David G. Patry [Canada] ; Yahya Agha-Khani [Canada] ; Christopher White [Canada] ; Justyna R. Sarna [Canada] ; Michael Yeung [Canada] ; V Wee Yong [Canada] ; Daniel Y C. Heng [Canada] ; Gary Cutter [États-Unis] ; Luanne Metz [Canada]Source :
- Nature reviews. Neurology [ 1759-4766 ] ; 2015.
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Abstract
Double-blinded randomized controlled trials (RCTs) have contributed much important evidence to guide treatment decisions in neurology. RCTs are relatively straightforward to conduct, provided that they investigate common diseases, have clearly defined outcome measures, and are of short duration. In neurology, however, many diseases are uncommon, have no consensus outcome measures, and develop over decades. Basic research into neurological diseases continues to identify candidate therapies faster than they can be tested for their clinical utility, leading to a 'translational gap'. Futility trials were initially developed in oncology to efficiently test candidate therapies in phase II trials. As single-arm unblinded studies, futility trials are relatively easy to conduct, and they generally require smaller sample sizes than RCTs. In this article, we discuss futility models, highlighting their advantages as well as challenges to their application in several neurological diseases, including Parkinson disease, stroke and multiple sclerosis.
DOI: 10.1038/nrneurol.2015.34
PubMed: 25776824
Affiliations:
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Koch</name><affiliation wicri:level="4"><nlm:affiliation>1] Department of Clinical Neurosciences, Foothills Hospital, University of Calgary, 1403 29th Street NW, Calgary, AB T2N 2T9, Canada. [2] Department of Community Health Sciences, TRW Building, University of Calgary, 3280 Hospital Drive NW, Calgary, AB T2N 4Z6, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>1] Department of Clinical Neurosciences, Foothills Hospital, University of Calgary, 1403 29th Street NW, Calgary, AB T2N 2T9, Canada. [2] Department of Community Health Sciences, TRW Building, University of Calgary, 3280 Hospital Drive NW, Calgary, AB T2N 4Z6</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation></author><author><name sortKey="Korngut, Lawrence" sort="Korngut, Lawrence" uniqKey="Korngut L" first="Lawrence" last="Korngut">Lawrence Korngut</name><affiliation wicri:level="4"><nlm:affiliation>Department of Clinical Neurosciences, Foothills Hospital, University of Calgary, 1403 29th Street NW, Calgary, AB T2N 2T9, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Clinical Neurosciences, Foothills Hospital, University of Calgary, 1403 29th Street NW, Calgary, AB T2N 2T9</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation></author><author><name sortKey="Patry, David G" sort="Patry, David G" uniqKey="Patry D" first="David G" last="Patry">David G. Patry</name><affiliation wicri:level="4"><nlm:affiliation>Department of Clinical Neurosciences, Foothills Hospital, University of Calgary, 1403 29th Street NW, Calgary, AB T2N 2T9, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Clinical Neurosciences, Foothills Hospital, University of Calgary, 1403 29th Street NW, Calgary, AB T2N 2T9</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation></author><author><name sortKey="Agha Khani, Yahya" sort="Agha Khani, Yahya" uniqKey="Agha Khani Y" first="Yahya" last="Agha-Khani">Yahya Agha-Khani</name><affiliation wicri:level="4"><nlm:affiliation>Department of Clinical Neurosciences, Foothills Hospital, University of Calgary, 1403 29th Street NW, Calgary, AB T2N 2T9, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Clinical Neurosciences, Foothills Hospital, University of Calgary, 1403 29th Street NW, Calgary, AB T2N 2T9</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation></author><author><name sortKey="White, Christopher" sort="White, Christopher" uniqKey="White C" first="Christopher" last="White">Christopher White</name><affiliation wicri:level="4"><nlm:affiliation>Department of Clinical Neurosciences, Foothills Hospital, University of Calgary, 1403 29th Street NW, Calgary, AB T2N 2T9, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Clinical Neurosciences, Foothills Hospital, University of Calgary, 1403 29th Street NW, Calgary, AB T2N 2T9</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation></author><author><name sortKey="Sarna, Justyna R" sort="Sarna, Justyna R" uniqKey="Sarna J" first="Justyna R" last="Sarna">Justyna R. Sarna</name><affiliation wicri:level="4"><nlm:affiliation>Department of Clinical Neurosciences, Foothills Hospital, University of Calgary, 1403 29th Street NW, Calgary, AB T2N 2T9, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Clinical Neurosciences, Foothills Hospital, University of Calgary, 1403 29th Street NW, Calgary, AB T2N 2T9</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation></author><author><name sortKey="Yeung, Michael" sort="Yeung, Michael" uniqKey="Yeung M" first="Michael" last="Yeung">Michael Yeung</name><affiliation wicri:level="4"><nlm:affiliation>Department of Clinical Neurosciences, Foothills Hospital, University of Calgary, 1403 29th Street NW, Calgary, AB T2N 2T9, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Clinical Neurosciences, Foothills Hospital, University of Calgary, 1403 29th Street NW, Calgary, AB T2N 2T9</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation></author><author><name sortKey="Yong, V Wee" sort="Yong, V Wee" uniqKey="Yong V" first="V Wee" last="Yong">V Wee Yong</name><affiliation wicri:level="4"><nlm:affiliation>Department of Clinical Neurosciences, Foothills Hospital, University of Calgary, 1403 29th Street NW, Calgary, AB T2N 2T9, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Clinical Neurosciences, Foothills Hospital, University of Calgary, 1403 29th Street NW, Calgary, AB T2N 2T9</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation></author><author><name sortKey="Heng, Daniel Y C" sort="Heng, Daniel Y C" uniqKey="Heng D" first="Daniel Y C" last="Heng">Daniel Y C. Heng</name><affiliation wicri:level="1"><nlm:affiliation>Department of Oncology, Tom Baker Cancer Centre, 1331 29th Street NW, Calgary, AB T2N 4N2, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Oncology, Tom Baker Cancer Centre, 1331 29th Street NW, Calgary, AB T2N 4N2</wicri:regionArea><wicri:noRegion>AB T2N 4N2</wicri:noRegion></affiliation></author><author><name sortKey="Cutter, Gary" sort="Cutter, Gary" uniqKey="Cutter G" first="Gary" last="Cutter">Gary Cutter</name><affiliation wicri:level="2"><nlm:affiliation>Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, 1665 University Boulevard, Birmingham, AL 35294-0022, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, 1665 University Boulevard, Birmingham, AL 35294-0022</wicri:regionArea><placeName><region type="state">Alabama</region></placeName></affiliation></author><author><name sortKey="Metz, Luanne" sort="Metz, Luanne" uniqKey="Metz L" first="Luanne" last="Metz">Luanne Metz</name><affiliation wicri:level="4"><nlm:affiliation>Department of Clinical Neurosciences, Foothills Hospital, University of Calgary, 1403 29th Street NW, Calgary, AB T2N 2T9, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Clinical Neurosciences, Foothills Hospital, University of Calgary, 1403 29th Street NW, Calgary, AB T2N 2T9</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation></author></analytic><series><title level="j">Nature reviews. Neurology</title><idno type="eISSN">1759-4766</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Clinical Trials, Phase II as Topic</term><term>Cognition Disorders (therapy)</term><term>Humans</term><term>Medical Futility</term><term>Models, Biological</term><term>Nervous System Diseases (therapy)</term><term>Randomized Controlled Trials as Topic</term><term>Sample Size</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Cognition Disorders</term><term>Nervous System Diseases</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Clinical Trials, Phase II as Topic</term><term>Humans</term><term>Medical Futility</term><term>Models, Biological</term><term>Randomized Controlled Trials as Topic</term><term>Sample Size</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Double-blinded randomized controlled trials (RCTs) have contributed much important evidence to guide treatment decisions in neurology. RCTs are relatively straightforward to conduct, provided that they investigate common diseases, have clearly defined outcome measures, and are of short duration. In neurology, however, many diseases are uncommon, have no consensus outcome measures, and develop over decades. Basic research into neurological diseases continues to identify candidate therapies faster than they can be tested for their clinical utility, leading to a 'translational gap'. Futility trials were initially developed in oncology to efficiently test candidate therapies in phase II trials. As single-arm unblinded studies, futility trials are relatively easy to conduct, and they generally require smaller sample sizes than RCTs. In this article, we discuss futility models, highlighting their advantages as well as challenges to their application in several neurological diseases, including Parkinson disease, stroke and multiple sclerosis.</div></front></TEI><affiliations><list><country><li>Canada</li><li>États-Unis</li></country><region><li>Alabama</li><li>Alberta</li></region><settlement><li>Calgary</li></settlement><orgName><li>Université de Calgary</li></orgName></list><tree><country name="Canada"><region name="Alberta"><name sortKey="Koch, Marcus W" sort="Koch, Marcus W" uniqKey="Koch M" first="Marcus W" last="Koch">Marcus W. Koch</name></region><name sortKey="Agha Khani, Yahya" sort="Agha Khani, Yahya" uniqKey="Agha Khani Y" first="Yahya" last="Agha-Khani">Yahya Agha-Khani</name><name sortKey="Heng, Daniel Y C" sort="Heng, Daniel Y C" uniqKey="Heng D" first="Daniel Y C" last="Heng">Daniel Y C. Heng</name><name sortKey="Korngut, Lawrence" sort="Korngut, Lawrence" uniqKey="Korngut L" first="Lawrence" last="Korngut">Lawrence Korngut</name><name sortKey="Metz, Luanne" sort="Metz, Luanne" uniqKey="Metz L" first="Luanne" last="Metz">Luanne Metz</name><name sortKey="Patry, David G" sort="Patry, David G" uniqKey="Patry D" first="David G" last="Patry">David G. Patry</name><name sortKey="Sarna, Justyna R" sort="Sarna, Justyna R" uniqKey="Sarna J" first="Justyna R" last="Sarna">Justyna R. Sarna</name><name sortKey="White, Christopher" sort="White, Christopher" uniqKey="White C" first="Christopher" last="White">Christopher White</name><name sortKey="Yeung, Michael" sort="Yeung, Michael" uniqKey="Yeung M" first="Michael" last="Yeung">Michael Yeung</name><name sortKey="Yong, V Wee" sort="Yong, V Wee" uniqKey="Yong V" first="V Wee" last="Yong">V Wee Yong</name></country><country name="États-Unis"><region name="Alabama"><name sortKey="Cutter, Gary" sort="Cutter, Gary" uniqKey="Cutter G" first="Gary" last="Cutter">Gary Cutter</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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