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<title xml:lang="en">How systematic reviews and meta-analyses based on individual participant data can inform trial design and conduct</title>
<author>
<name sortKey="Tierney, Jayne" sort="Tierney, Jayne" uniqKey="Tierney J" first="Jayne" last="Tierney">Jayne Tierney</name>
<affiliation>
<nlm:aff id="I1">MRC Clinical Trials Unit Hub for Trials Methodology Research, London, UK</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Vale, Claire" sort="Vale, Claire" uniqKey="Vale C" first="Claire" last="Vale">Claire Vale</name>
<affiliation>
<nlm:aff id="I1">MRC Clinical Trials Unit Hub for Trials Methodology Research, London, UK</nlm:aff>
</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>
<nlm:aff id="I2">Institut Gustave Roussy, Villejuif, France</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Gueffyier, Francois" sort="Gueffyier, Francois" uniqKey="Gueffyier F" first="Francois" last="Gueffyier">Francois Gueffyier</name>
<affiliation>
<nlm:aff id="I3">UMR5558, CNRS, Lyon, France</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Askie, Lisa" sort="Askie, Lisa" uniqKey="Askie L" first="Lisa" last="Askie">Lisa Askie</name>
<affiliation>
<nlm:aff id="I4">NHMRC Clinical Trials Centre, Sydney, Australia</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Clarke, Mike" sort="Clarke, Mike" uniqKey="Clarke M" first="Mike" last="Clarke">Mike Clarke</name>
<affiliation>
<nlm:aff id="I5">All-Ireland Hub for Trials Methodology Research, Belfast, Ireland</nlm:aff>
</affiliation>
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<idno type="pmc">3980753</idno>
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<idno type="doi">10.1186/1745-6215-14-S1-O94</idno>
<idno type="pmid">NONE</idno>
<date when="2013">2013</date>
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<title xml:lang="en" level="a" type="main">How systematic reviews and meta-analyses based on individual participant data can inform trial design and conduct</title>
<author>
<name sortKey="Tierney, Jayne" sort="Tierney, Jayne" uniqKey="Tierney J" first="Jayne" last="Tierney">Jayne Tierney</name>
<affiliation>
<nlm:aff id="I1">MRC Clinical Trials Unit Hub for Trials Methodology Research, London, UK</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Vale, Claire" sort="Vale, Claire" uniqKey="Vale C" first="Claire" last="Vale">Claire Vale</name>
<affiliation>
<nlm:aff id="I1">MRC Clinical Trials Unit Hub for Trials Methodology Research, London, UK</nlm:aff>
</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>
<nlm:aff id="I2">Institut Gustave Roussy, Villejuif, France</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Gueffyier, Francois" sort="Gueffyier, Francois" uniqKey="Gueffyier F" first="Francois" last="Gueffyier">Francois Gueffyier</name>
<affiliation>
<nlm:aff id="I3">UMR5558, CNRS, Lyon, France</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Askie, Lisa" sort="Askie, Lisa" uniqKey="Askie L" first="Lisa" last="Askie">Lisa Askie</name>
<affiliation>
<nlm:aff id="I4">NHMRC Clinical Trials Centre, Sydney, Australia</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Clarke, Mike" sort="Clarke, Mike" uniqKey="Clarke M" first="Mike" last="Clarke">Mike Clarke</name>
<affiliation>
<nlm:aff id="I5">All-Ireland Hub for Trials Methodology Research, Belfast, Ireland</nlm:aff>
</affiliation>
</author>
</analytic>
<series>
<title level="j">Trials</title>
<idno type="eISSN">1745-6215</idno>
<imprint>
<date when="2013">2013</date>
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<pmc article-type="abstract" xml:lang="en">
<pmc-dir>properties open_access</pmc-dir>
<front>
<journal-meta>
<journal-id journal-id-type="nlm-ta">Trials</journal-id>
<journal-id journal-id-type="iso-abbrev">Trials</journal-id>
<journal-title-group>
<journal-title>Trials</journal-title>
</journal-title-group>
<issn pub-type="epub">1745-6215</issn>
<publisher>
<publisher-name>BioMed Central</publisher-name>
</publisher>
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<article-meta>
<article-id pub-id-type="pmc">3980753</article-id>
<article-id pub-id-type="publisher-id">1745-6215-14-S1-O94</article-id>
<article-id pub-id-type="doi">10.1186/1745-6215-14-S1-O94</article-id>
<article-categories>
<subj-group subj-group-type="heading">
<subject>Oral Presentation</subject>
</subj-group>
</article-categories>
<title-group>
<article-title>How systematic reviews and meta-analyses based on individual participant data can inform trial design and conduct</article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author" corresp="yes" id="A1">
<name>
<surname>Tierney</surname>
<given-names>Jayne</given-names>
</name>
<xref ref-type="aff" rid="I1">1</xref>
</contrib>
<contrib contrib-type="author" id="A2">
<name>
<surname>Vale</surname>
<given-names>Claire</given-names>
</name>
<xref ref-type="aff" rid="I1">1</xref>
</contrib>
<contrib contrib-type="author" id="A3">
<name>
<surname>Pignon</surname>
<given-names>Jean-Pierre</given-names>
</name>
<xref ref-type="aff" rid="I2">2</xref>
</contrib>
<contrib contrib-type="author" id="A4">
<name>
<surname>Gueffyier</surname>
<given-names>Francois</given-names>
</name>
<xref ref-type="aff" rid="I3">3</xref>
</contrib>
<contrib contrib-type="author" id="A5">
<name>
<surname>Askie</surname>
<given-names>Lisa</given-names>
</name>
<xref ref-type="aff" rid="I4">4</xref>
</contrib>
<contrib contrib-type="author" id="A6">
<name>
<surname>Clarke</surname>
<given-names>Mike</given-names>
</name>
<xref ref-type="aff" rid="I5">5</xref>
</contrib>
</contrib-group>
<aff id="I1">
<label>1</label>
MRC Clinical Trials Unit Hub for Trials Methodology Research, London, UK</aff>
<aff id="I2">
<label>2</label>
Institut Gustave Roussy, Villejuif, France</aff>
<aff id="I3">
<label>3</label>
UMR5558, CNRS, Lyon, France</aff>
<aff id="I4">
<label>4</label>
NHMRC Clinical Trials Centre, Sydney, Australia</aff>
<aff id="I5">
<label>5</label>
All-Ireland Hub for Trials Methodology Research, Belfast, Ireland</aff>
<pub-date pub-type="collection">
<year>2013</year>
</pub-date>
<pub-date pub-type="epub">
<day>29</day>
<month>11</month>
<year>2013</year>
</pub-date>
<volume>14</volume>
<issue>Suppl 1</issue>
<supplement>
<named-content content-type="supplement-title">2nd Clinical Trials Methodology Conference: Methodology Matters</named-content>
<named-content content-type="supplement-sponsor">Publication of this supplement was funded by the 2nd Clinical TrialsMethodology Conference.</named-content>
</supplement>
<fpage>O94</fpage>
<lpage>O94</lpage>
<permissions>
<copyright-statement>Copyright © 2013 Tierney et al; licensee BioMed Central Ltd.</copyright-statement>
<copyright-year>2013</copyright-year>
<copyright-holder>Tierney et al; licensee BioMed Central Ltd.</copyright-holder>
<license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/2.0">
<license-p>This is an Open Access article distributed under the terms of the Creative Commons Attribution License (
<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/2.0">http://creativecommons.org/licenses/by/2.0</ext-link>
), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
</license>
</permissions>
<self-uri xlink:href="http://www.trialsjournal.com/content/14/S1/O94"></self-uri>
<conference>
<conf-date>18-19 November 2013</conf-date>
<conf-name>2nd Clinical Trials Methodology Conference: Methodology Matters</conf-name>
<conf-loc>Edinburgh, UK</conf-loc>
</conference>
</article-meta>
</front>
<body>
<sec sec-type="intro">
<title>Introduction</title>
<p>Systematic reviews and meta-analyses provide an objective and reliable way of summarising trial results, and can inform both clinical practice and the design, conduct and reporting of trials. However, those based on aggregate data are sometimes limited by the availability of such data, while those based on more comprehensive individual participant data (IPD) can provide more detailed and reliable results. Also, IPD meta-analyses provide a resource for secondary hypothesis testing, which can produce further clinical insight, and rely on close collaboration with trials organisations worldwide. Thus, IPD meta-analyses have the potential to better inform new and on-going trials.</p>
</sec>
<sec sec-type="methods">
<title>Methods</title>
<p>Initially, we sought examples of IPD meta-analyses that have directly influenced the design and conduct of trials, via a workshop of international experts in the field, and subsequently, through this subgroup of workshop attendees. We also considered additional ways that IPD meta-analysis could impact on trials.</p>
</sec>
<sec sec-type="results">
<title>Results</title>
<p>In terms of trial design, IPD meta-analyses results have informed the choice of comparators; definition of trial populations; sample size calculations and effect sizes to target. They have also been the catalyst for international collaboration on new trials; justified both continuing and stopping trial recruitment, and informed stratification of trial analyses. They have the potential to inform other aspects, such as the choice and definition of outcomes. We illustrate these impacts in a range of health care areas including cancer, cardiovascular disease, stroke and neonatal care.</p>
</sec>
<sec sec-type="conclusions">
<title>Conclusions</title>
<p>IPD meta-analyses have impacted on trials in various ways, but might be utilised more widely.</p>
</sec>
</body>
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