How individual participant data meta-analyses have influenced trial design, conduct, and analysis
Identifieur interne : 002C94 ( Main/Exploration ); précédent : 002C93; suivant : 002C95How individual participant data meta-analyses have influenced trial design, conduct, and analysis
Auteurs : Jayne F. Tierney [Royaume-Uni] ; Jean-Pierre Pignon [France] ; Francois Gueffyier [France] ; Mike Clarke [Royaume-Uni] ; Lisa Askie ; Claire L. Vale [Royaume-Uni] ; Sarah Burdett [Royaume-Uni]Source :
- Journal of Clinical Epidemiology [ 0895-4356 ] ; 2015.
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Abstract
To demonstrate how individual participant data (IPD) meta-analyses have impacted directly on the design and conduct of trials and highlight other advantages IPD might offer.
Potential examples of the impact of IPD meta-analyses on trials were identified at an international workshop, attended by individuals with experience in the conduct of IPD meta-analyses and knowledge of trials in their respective clinical areas. Experts in the field who did not attend were asked to provide any further examples. We then examined relevant trial protocols, publications, and Web sites to verify the impacts of the IPD meta-analyses. A subgroup of workshop attendees sought further examples and identified other aspects of trial design and conduct that may inform IPD meta-analyses.
We identified 52 examples of IPD meta-analyses thought to have had a direct impact on the design or conduct of trials. After screening relevant trial protocols and publications, we identified 28 instances where IPD meta-analyses had clearly impacted on trials. They have influenced the selection of comparators and participants, sample size calculations, analysis and interpretation of subsequent trials, and the conduct and analysis of ongoing trials, sometimes in ways that would not possible with systematic reviews of aggregate data. We identified additional potential ways that IPD meta-analyses could be used to influence trials.
IPD meta-analysis could be better used to inform the design, conduct, analysis, and interpretation of trials.
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DOI: 10.1016/j.jclinepi.2015.05.024
PubMed: 26186982
PubMed Central: 4635379
Affiliations:
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Tierney</name><affiliation wicri:level="1"><nlm:aff id="aff1">MRC Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London WC2B 6NH, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>MRC Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London WC2B 6NH</wicri:regionArea><wicri:noRegion>London WC2B 6NH</wicri:noRegion></affiliation></author><author><name sortKey="Pignon, Jean Pierre" sort="Pignon, Jean Pierre" uniqKey="Pignon J" first="Jean-Pierre" last="Pignon">Jean-Pierre Pignon</name><affiliation wicri:level="1"><nlm:aff id="aff2">LNCC plateforme de méta-analyse en oncologie, Service de Biostatistique et d’Epidemiologie, Gustave-Roussy, Villejuif, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>LNCC plateforme de méta-analyse en oncologie, Service de Biostatistique et d’Epidemiologie, Gustave-Roussy, Villejuif</wicri:regionArea><wicri:noRegion>Villejuif</wicri:noRegion><wicri:noRegion>Villejuif</wicri:noRegion></affiliation></author><author><name sortKey="Gueffyier, Francois" sort="Gueffyier, Francois" uniqKey="Gueffyier F" first="Francois" last="Gueffyier">Francois Gueffyier</name><affiliation wicri:level="3"><nlm:aff id="aff3">Université Claude Bernard Lyon 1/Université de Lyon, 69365 Lyon Cedex 07, Lyon, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Université Claude Bernard Lyon 1/Université de Lyon, 69365 Lyon Cedex 07, Lyon</wicri:regionArea><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Lyon</settlement></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="aff4">Service de Pharmacologie Clinique, Hospices Civils de Lyon, Bron cedex, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Service de Pharmacologie Clinique, Hospices Civils de Lyon, Bron cedex</wicri:regionArea><wicri:noRegion>Bron cedex</wicri:noRegion><wicri:noRegion>Bron cedex</wicri:noRegion></affiliation></author><author><name sortKey="Clarke, Mike" sort="Clarke, Mike" uniqKey="Clarke M" first="Mike" last="Clarke">Mike Clarke</name><affiliation wicri:level="1"><nlm:aff id="aff5">All-Ireland Hub for Trials Methodology Research, Queen's University Belfast, University Road, Belfast BT7 1NN, Northern Ireland, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>All-Ireland Hub for Trials Methodology Research, Queen's University Belfast, University Road, Belfast BT7 1NN, Northern Ireland</wicri:regionArea><wicri:noRegion>Northern Ireland</wicri:noRegion></affiliation></author><author><name sortKey="Askie, Lisa" sort="Askie, Lisa" uniqKey="Askie L" first="Lisa" last="Askie">Lisa Askie</name><affiliation><nlm:aff id="aff6">NHMRC Clinical Trials Centre, ABN 15 211 513 464, Locked Bag 77, Camperdown, NSW 1450 Australia</nlm:aff><wicri:noCountry code="subfield">NSW 1450 Australia</wicri:noCountry></affiliation></author><author><name sortKey="Vale, Claire L" sort="Vale, Claire L" uniqKey="Vale C" first="Claire L." last="Vale">Claire L. Vale</name><affiliation wicri:level="1"><nlm:aff id="aff1">MRC Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London WC2B 6NH, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>MRC Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London WC2B 6NH</wicri:regionArea><wicri:noRegion>London WC2B 6NH</wicri:noRegion></affiliation></author><author><name sortKey="Burdett, Sarah" sort="Burdett, Sarah" uniqKey="Burdett S" first="Sarah" last="Burdett">Sarah Burdett</name><affiliation wicri:level="1"><nlm:aff id="aff1">MRC Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London WC2B 6NH, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>MRC Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London WC2B 6NH</wicri:regionArea><wicri:noRegion>London WC2B 6NH</wicri:noRegion></affiliation></author></analytic><series><title level="j">Journal of Clinical Epidemiology</title><idno type="ISSN">0895-4356</idno><idno type="eISSN">1878-5921</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Clinical Trials as Topic (methods)</term><term>Humans</term><term>Meta-Analysis as Topic</term><term>Research Design</term><term>Research Subjects</term><term>Statistics as Topic</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Essais cliniques comme sujet ()</term><term>Humains</term><term>Méta-analyse comme sujet</term><term>Personnes se prêtant à la recherche</term><term>Plan de recherche</term><term>Statistiques comme sujet</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Clinical Trials as Topic</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Humans</term><term>Meta-Analysis as Topic</term><term>Research Design</term><term>Research Subjects</term><term>Statistics as Topic</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Essais cliniques comme sujet</term><term>Humains</term><term>Méta-analyse comme sujet</term><term>Personnes se prêtant à la recherche</term><term>Plan de recherche</term><term>Statistiques comme sujet</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Objectives</title><p>To demonstrate how individual participant data (IPD) meta-analyses have impacted directly on the design and conduct of trials and highlight other advantages IPD might offer.</p></sec><sec><title>Study Design and Setting</title><p>Potential examples of the impact of IPD meta-analyses on trials were identified at an international workshop, attended by individuals with experience in the conduct of IPD meta-analyses and knowledge of trials in their respective clinical areas. Experts in the field who did not attend were asked to provide any further examples. We then examined relevant trial protocols, publications, and Web sites to verify the impacts of the IPD meta-analyses. A subgroup of workshop attendees sought further examples and identified other aspects of trial design and conduct that may inform IPD meta-analyses.</p></sec><sec><title>Results</title><p>We identified 52 examples of IPD meta-analyses thought to have had a direct impact on the design or conduct of trials. After screening relevant trial protocols and publications, we identified 28 instances where IPD meta-analyses had clearly impacted on trials. They have influenced the selection of comparators and participants, sample size calculations, analysis and interpretation of subsequent trials, and the conduct and analysis of ongoing trials, sometimes in ways that would not possible with systematic reviews of aggregate data. We identified additional potential ways that IPD meta-analyses could be used to influence trials.</p></sec><sec><title>Conclusions</title><p>IPD meta-analysis could be better used to inform the design, conduct, analysis, and interpretation of trials.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Clarke, M" uniqKey="Clarke M">M. Clarke</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Cooper, N J" uniqKey="Cooper N">N.J. Cooper</name></author><author><name sortKey="Jones, D R" uniqKey="Jones D">D.R. Jones</name></author><author><name sortKey="Sutton, A J" uniqKey="Sutton A">A.J. Sutton</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Clarke, M" uniqKey="Clarke M">M. Clarke</name></author><author><name sortKey="Hopewell, S" uniqKey="Hopewell S">S. Hopewell</name></author><author><name sortKey="Chalmers, I" uniqKey="Chalmers I">I. 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Groves</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>France</li><li>Royaume-Uni</li></country><region><li>Auvergne-Rhône-Alpes</li><li>Rhône-Alpes</li></region><settlement><li>Lyon</li></settlement></list><tree><noCountry><name sortKey="Askie, Lisa" sort="Askie, Lisa" uniqKey="Askie L" first="Lisa" last="Askie">Lisa Askie</name></noCountry><country name="Royaume-Uni"><noRegion><name sortKey="Tierney, Jayne F" sort="Tierney, Jayne F" uniqKey="Tierney J" first="Jayne F." last="Tierney">Jayne F. Tierney</name></noRegion><name sortKey="Burdett, Sarah" sort="Burdett, Sarah" uniqKey="Burdett S" first="Sarah" last="Burdett">Sarah Burdett</name><name sortKey="Clarke, Mike" sort="Clarke, Mike" uniqKey="Clarke M" first="Mike" last="Clarke">Mike Clarke</name><name sortKey="Vale, Claire L" sort="Vale, Claire L" uniqKey="Vale C" first="Claire L." last="Vale">Claire L. Vale</name></country><country name="France"><noRegion><name sortKey="Pignon, Jean Pierre" sort="Pignon, Jean Pierre" uniqKey="Pignon J" first="Jean-Pierre" last="Pignon">Jean-Pierre Pignon</name></noRegion><name sortKey="Gueffyier, Francois" sort="Gueffyier, Francois" uniqKey="Gueffyier F" first="Francois" last="Gueffyier">Francois Gueffyier</name><name sortKey="Gueffyier, Francois" sort="Gueffyier, Francois" uniqKey="Gueffyier F" first="Francois" last="Gueffyier">Francois Gueffyier</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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