Conducting a randomised trial during an influenza pandemic: an example of a trial set up and ‘hibernated’ ready to activate and recruit within 4 weeks
Identifieur interne : 000399 ( Pmc/Corpus ); précédent : 000398; suivant : 000400Conducting a randomised trial during an influenza pandemic: an example of a trial set up and ‘hibernated’ ready to activate and recruit within 4 weeks
Auteurs : Clare Brittain ; Garry Meakin ; Margo Childs ; Lelia Duley ; Wei Shen LimSource :
- Trials [ 1745-6215 ] ; 2015.
Url:
DOI: 10.1186/1745-6215-16-S2-O14
PubMed: NONE
PubMed Central: 4659282
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Conducting a randomised trial during an influenza pandemic: an example of a trial set up and ‘hibernated’ ready to activate and recruit within 4 weeks</title><author><name sortKey="Brittain, Clare" sort="Brittain, Clare" uniqKey="Brittain C" first="Clare" last="Brittain">Clare Brittain</name><affiliation><nlm:aff id="I1">Nottingham Clinical Trials Unit, Nottingham, UK</nlm:aff></affiliation></author><author><name sortKey="Meakin, Garry" sort="Meakin, Garry" uniqKey="Meakin G" first="Garry" last="Meakin">Garry Meakin</name><affiliation><nlm:aff id="I1">Nottingham Clinical Trials Unit, Nottingham, UK</nlm:aff></affiliation></author><author><name sortKey="Childs, Margo" sort="Childs, Margo" uniqKey="Childs M" first="Margo" last="Childs">Margo Childs</name><affiliation><nlm:aff id="I1">Nottingham Clinical Trials Unit, Nottingham, UK</nlm:aff></affiliation></author><author><name sortKey="Duley, Lelia" sort="Duley, Lelia" uniqKey="Duley L" first="Lelia" last="Duley">Lelia Duley</name><affiliation><nlm:aff id="I1">Nottingham Clinical Trials Unit, Nottingham, UK</nlm:aff></affiliation></author><author><name sortKey="Lim, Wei Shen" sort="Lim, Wei Shen" uniqKey="Lim W" first="Wei Shen" last="Lim">Wei Shen Lim</name><affiliation><nlm:aff id="I2">Nottingham University Hospitals NHS Trust, Nottingham, UK</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmc">4659282</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4659282</idno><idno type="RBID">PMC:4659282</idno><idno type="doi">10.1186/1745-6215-16-S2-O14</idno><idno type="pmid">NONE</idno><date when="2015">2015</date><idno type="wicri:Area/Pmc/Corpus">000399</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000399</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Conducting a randomised trial during an influenza pandemic: an example of a trial set up and ‘hibernated’ ready to activate and recruit within 4 weeks</title><author><name sortKey="Brittain, Clare" sort="Brittain, Clare" uniqKey="Brittain C" first="Clare" last="Brittain">Clare Brittain</name><affiliation><nlm:aff id="I1">Nottingham Clinical Trials Unit, Nottingham, UK</nlm:aff></affiliation></author><author><name sortKey="Meakin, Garry" sort="Meakin, Garry" uniqKey="Meakin G" first="Garry" last="Meakin">Garry Meakin</name><affiliation><nlm:aff id="I1">Nottingham Clinical Trials Unit, Nottingham, UK</nlm:aff></affiliation></author><author><name sortKey="Childs, Margo" sort="Childs, Margo" uniqKey="Childs M" first="Margo" last="Childs">Margo Childs</name><affiliation><nlm:aff id="I1">Nottingham Clinical Trials Unit, Nottingham, UK</nlm:aff></affiliation></author><author><name sortKey="Duley, Lelia" sort="Duley, Lelia" uniqKey="Duley L" first="Lelia" last="Duley">Lelia Duley</name><affiliation><nlm:aff id="I1">Nottingham Clinical Trials Unit, Nottingham, UK</nlm:aff></affiliation></author><author><name sortKey="Lim, Wei Shen" sort="Lim, Wei Shen" uniqKey="Lim W" first="Wei Shen" last="Lim">Wei Shen Lim</name><affiliation><nlm:aff id="I2">Nottingham University Hospitals NHS Trust, Nottingham, UK</nlm:aff></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader></TEI><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></journal-meta><article-meta><article-id pub-id-type="pmc">4659282</article-id><article-id pub-id-type="publisher-id">1745-6215-16-S2-O14</article-id><article-id pub-id-type="doi">10.1186/1745-6215-16-S2-O14</article-id><article-categories><subj-group subj-group-type="heading"><subject>Oral Presentation</subject></subj-group></article-categories><title-group><article-title>Conducting a randomised trial during an influenza pandemic: an example of a trial set up and ‘hibernated’ ready to activate and recruit within 4 weeks</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes" id="A1"><name><surname>Brittain</surname><given-names>Clare</given-names></name><xref ref-type="aff" rid="I1">1</xref></contrib><contrib contrib-type="author" id="A2"><name><surname>Meakin</surname><given-names>Garry</given-names></name><xref ref-type="aff" rid="I1">1</xref></contrib><contrib contrib-type="author" id="A3"><name><surname>Childs</surname><given-names>Margo</given-names></name><xref ref-type="aff" rid="I1">1</xref></contrib><contrib contrib-type="author" id="A4"><name><surname>Duley</surname><given-names>Lelia</given-names></name><xref ref-type="aff" rid="I1">1</xref></contrib><contrib contrib-type="author" id="A5"><name><surname>Lim</surname><given-names>Wei Shen</given-names></name><xref ref-type="aff" rid="I2">2</xref></contrib></contrib-group><aff id="I1"><label>1</label>Nottingham Clinical Trials Unit, Nottingham, UK</aff><aff id="I2"><label>2</label>Nottingham University Hospitals NHS Trust, Nottingham, UK</aff><pub-date pub-type="collection"><year>2015</year></pub-date><pub-date pub-type="epub"><day>16</day><month>11</month><year>2015</year></pub-date><volume>16</volume><issue>Suppl 2</issue><supplement><named-content content-type="supplement-title">3rd International Clinical Trials Methodology Conference</named-content><named-content content-type="supplement-sponsor">Publication of this supplement was funded by the 3rd Clinical Trials Methodology Conference.</named-content></supplement><fpage>O14</fpage><lpage>O14</lpage><permissions><copyright-statement>Copyright © 2015 Brittain et al.</copyright-statement><copyright-year>2015</copyright-year><copyright-holder>Brittain et al.</copyright-holder><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/4.0"><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/4.0">http://creativecommons.org/licenses/by/4.0</ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>) applies to the data made available in this article, unless otherwise stated.</license-p></license></permissions><self-uri xlink:href="http://www.trialsjournal.com/content/16/S2/O14"></self-uri><conference><conf-date>16-17 November 2015</conf-date><conf-name>3rd International Clinical Trials Methodology Conference</conf-name><conf-loc>Glasgow, UK</conf-loc></conference></article-meta></front><body><sec><title>Background</title><p>No randomised controlled trial has been successfully conducted during an influenza pandemic. The ASAP trial (Adjuvant Steroids in Adults with Pandemic Influenza) aims to use the novel strategy of set-up in advance of an influenza pandemic, and ‘hibernation’ in readiness for activation in a pandemic. Upon activation, the trial needs to recruit the first participant within 4 weeks, and to complete recruitment of 2200 participants within the first pandemic wave of approximately 6 weeks.</p></sec><sec><title>Methods</title><p>Approvals are in place for 40 sites being maintained in ‘hibernation’. Three key programmes of work during hibernation have been identified: 1) Regular review to ensure compliance with current regulations, viability of Investigational Medicinal Product (IMP) and appropriate trial materials, 2) Planning for the ‘pre-activation’ phase (time between trial activation and first participant recruited), 3) Clinical Trials Unit (CTU) planning for activation.</p></sec><sec><title>Results</title><p>Regular review includes detailed annual checks of trial site readiness and interest, review of trial materials and contracts, replacement of expiring IMP, maintenance of trial oversight committees and reporting to stakeholders. Planning for pre-activation includes packaging of IMP, developing of training materials, and logistical aspects of trial delivery including changes in key trial staff. The CTU is also developing an operational plan to support activation and reporting.</p></sec><sec><title>Discussion</title><p>Long term maintenance of a clinical trial in readiness for a public health emergency is extremely challenging. Careful planning and detailed procedures should enable rapid activation and delivery of this trial. Anticipating future uncertainties is a key facet of trial maintenance during hibernation.</p></sec></body></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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