The promise of futility trials in neurological diseases.
Identifieur interne : 001B01 ( Ncbi/Merge ); précédent : 001B00; suivant : 001B02The 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.
English descriptors
- KwdEn :
- MESH :
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
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<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>
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<Abstract><AbstractText>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.</AbstractText>
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<AffiliationInfo><Affiliation>Department of Oncology, Tom Baker Cancer Centre, 1331 29th Street NW, Calgary, AB T2N 4N2, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Cutter</LastName>
<ForeName>Gary</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, 1665 University Boulevard, Birmingham, AL 35294-0022, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Metz</LastName>
<ForeName>Luanne</ForeName>
<Initials>L</Initials>
<AffiliationInfo><Affiliation>Department of Clinical Neurosciences, Foothills Hospital, University of Calgary, 1403 29th Street NW, Calgary, AB T2N 2T9, Canada.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016454">Review</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2015</Year>
<Month>03</Month>
<Day>17</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>England</Country>
<MedlineTA>Nat Rev Neurol</MedlineTA>
<NlmUniqueID>101500072</NlmUniqueID>
<ISSNLinking>1759-4758</ISSNLinking>
</MedlineJournalInfo>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList><MeshHeading><DescriptorName UI="D017322" MajorTopicYN="N">Clinical Trials, Phase II as Topic</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D003072" MajorTopicYN="N">Cognition Disorders</DescriptorName>
<QualifierName UI="Q000628" MajorTopicYN="N">therapy</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D018447" MajorTopicYN="N">Medical Futility</DescriptorName>
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<MeshHeading><DescriptorName UI="D008954" MajorTopicYN="N">Models, Biological</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D009422" MajorTopicYN="N">Nervous System Diseases</DescriptorName>
<QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016032" MajorTopicYN="N">Randomized Controlled Trials as Topic</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D018401" MajorTopicYN="N">Sample Size</DescriptorName>
</MeshHeading>
</MeshHeadingList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2015</Year>
<Month>3</Month>
<Day>18</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<PubMedPubDate PubStatus="pubmed"><Year>2015</Year>
<Month>3</Month>
<Day>18</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<PubMedPubDate PubStatus="medline"><Year>2016</Year>
<Month>3</Month>
<Day>22</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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</History>
<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList><ArticleId IdType="pubmed">25776824</ArticleId>
<ArticleId IdType="pii">nrneurol.2015.34</ArticleId>
<ArticleId IdType="doi">10.1038/nrneurol.2015.34</ArticleId>
</ArticleIdList>
</PubmedData>
</pubmed>
<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>
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