SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
Identifieur interne : 002A65 ( Istex/Corpus ); précédent : 002A64; suivant : 002A66SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
Auteurs : An-Wen Chan ; Jennifer M. Tetzlaff ; Peter C. G Tzsche ; Douglas G. Altman ; Howard Mann ; Jesse A. Berlin ; Kay Dickersin ; Asbj Rn Hr Bjartsson ; Kenneth F. Schulz ; Wendy R. Parulekar ; Karmela Krleža-Jeri ; Andreas Laupacis ; David MoherSource :
- BMJ : British Medical Journal [ 0959-8138 ] ; 2013-01-09.
Abstract
High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
Url:
DOI: 10.1136/bmj.e7586
Links to Exploration step
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<front><div type="abstract">High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.</div>
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<abstract><p>High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.</p>
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<title-group><article-title>SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials</article-title>
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<contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Chan</surname>
<given-names>An-Wen</given-names>
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<role>Phelan scientist</role>
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<given-names>Jennifer M</given-names>
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<role>research coordinator</role>
<xref ref-type="aff" rid="aff2">2</xref>
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<contrib contrib-type="author" corresp="no"><name><surname>Gøtzsche</surname>
<given-names>Peter C</given-names>
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<role>professor and director</role>
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<contrib contrib-type="author" corresp="no"><name><surname>Altman</surname>
<given-names>Douglas G</given-names>
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<role>professor and director</role>
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<contrib contrib-type="author" corresp="no"><name><surname>Mann</surname>
<given-names>Howard</given-names>
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<contrib contrib-type="author" corresp="no"><name><surname>Berlin</surname>
<given-names>Jesse A</given-names>
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<role>vice president, epidemiology</role>
<xref ref-type="aff" rid="aff6">6</xref>
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<contrib contrib-type="author" corresp="no"><name><surname>Dickersin</surname>
<given-names>Kay</given-names>
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<role>professor and director</role>
<xref ref-type="aff" rid="aff7">7</xref>
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<contrib contrib-type="author" corresp="no"><name><surname>Krleža-Jerić</surname>
<given-names>Karmela</given-names>
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<role>adjunct professor</role>
<xref ref-type="aff" rid="aff10">10</xref>
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<contrib contrib-type="author" corresp="no"><name><surname>Laupacis</surname>
<given-names>Andreas</given-names>
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<aff id="aff1"><label>1</label>
Women’s College Research Institute at Women’s College Hospital, Department of Medicine, University of Toronto, Toronto, Canada, M5G 1N8</aff>
<aff id="aff2"><label>2</label>
Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada</aff>
<aff id="aff3"><label>3</label>
Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark</aff>
<aff id="aff4"><label>4</label>
Centre for Statistics in Medicine, University of Oxford, Oxford, UK</aff>
<aff id="aff5"><label>5</label>
Division of Medical Ethics and Humanities, University of Utah School of Medicine, Salt Lake City, USA</aff>
<aff id="aff6"><label>6</label>
Janssen Research and Development, Titusville, USA</aff>
<aff id="aff7"><label>7</label>
Center for Clinical Trials, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA</aff>
<aff id="aff8"><label>8</label>
Quantitative Sciences, FHI 360, Research Triangle Park, USA</aff>
<aff id="aff9"><label>9</label>
NCIC Clinical Trials Group, Cancer Research Institute, Queen’s University, Kingston, Canada</aff>
<aff id="aff10"><label>10</label>
Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada</aff>
<aff id="aff11"><label>11</label>
Keenan Research Centre at the Li Ka Shing Knowledge Institute of St Michael’s Hospital, Faculty of Medicine, University of Toronto, Toronto, Canada</aff>
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<author-notes><corresp>Correspondence to: A-W Chan <email>anwen.chan@utoronto.ca</email>
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<abstract><p>High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol.</p>
<p> This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (<ext-link xlink:href="http://www.spirit-statement.org/" ext-link-type="uri" xlink:type="simple">www.spirit-statement.org</ext-link>
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