<rdf:RDF xmlns:rdf="http://www.openarchives.org/OAI/2.0/rdf/" xmlns:ow="http://www.ontoweb.org/ontology/1#" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:ds="http://dspace.org/ds/elements/1.1/" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:doc="http://www.lyncode.com/xoai" xsi:schemaLocation="http://www.openarchives.org/OAI/2.0/rdf/ http://www.openarchives.org/OAI/2.0/rdf.xsd">
   <ow:Publication rdf:about="oai:digibug.ugr.es:10481/92484">
      <dc:title>International multi‑stakeholder consensus statement on clinical trial integrity</dc:title>
      <dc:creator>Saeed Khan, Khalid</dc:creator>
      <dc:creator>Cairo Consensus Group on Research Integrity</dc:creator>
      <dc:subject>Randomised controlled trials</dc:subject>
      <dc:subject>Research integrity</dc:subject>
      <dc:description>Objective To prepare a set of statements for randomised clinical trials (RCT) integrity through an international multi-stakeholder&#xd;
consensus.&#xd;
Methods The consensus was developed via multi-country multidisciplinary stakeholder group composition&#xd;
and engagement; evidence synthesis of 55 systematic reviews concerning RCT integrity; anonymized two-round&#xd;
modified Delphi survey with consensus threshold based on the average percentage of majority opinions; and a final&#xd;
consensus development meeting. Prospective registrations: (https://osf.io/bhncy, https://osf.io/3ursn).&#xd;
Results There were 30 stakeholders representing 15 countries from five continents including trialists, ethicists, methodologists,&#xd;
statisticians, consumer representatives, industry representatives, systematic reviewers, funding body panel&#xd;
members, regulatory experts, authors, journal editors, peer reviewers and advisors for resolving integrity concerns.&#xd;
Delphi survey response rate was 86.7% (26/30 stakeholders). There were 111 statements (73 stakeholder-provided, 46&#xd;
systematic review-generated, 8 supported by both) in the initial long list, with eight additional statements provided&#xd;
during the consensus rounds. Through consensus the final set consolidated 81 statements (49 stakeholder-provided,&#xd;
41 systematic review-generated, 9 supported by both). The entire RCT life cycle was covered by the set of statements&#xd;
including general aspects (n = 6), design and approval (n = 11), conduct and monitoring (n = 19), reporting of protocols&#xd;
and findings (n = 20), post-publication concerns (n = 12) and future research and development (n = 13).&#xd;
Conclusion Implementation of this multi-stakeholder consensus statement is expected to enhance RCT integrity.</dc:description>
      <dc:date>2024-06-11T07:50:21Z</dc:date>
      <dc:date>2024-06-11T07:50:21Z</dc:date>
      <dc:date>2024-04-05</dc:date>
      <dc:type>info:eu-repo/semantics/article</dc:type>
      <dc:identifier>Khan, K.S., for the Cairo Consensus Group on Research Integrity. International multi-stakeholder consensus statement on clinical trial integrity. Middle East Fertil Soc J 29, 20 (2024). https://doi.org/10.1186/s43043-024-00171-z</dc:identifier>
      <dc:identifier>https://hdl.handle.net/10481/92484</dc:identifier>
      <dc:identifier>10.1186/s43043-024-00171-z</dc:identifier>
      <dc:language>eng</dc:language>
      <dc:rights>http://creativecommons.org/licenses/by-nc-nd/4.0/</dc:rights>
      <dc:rights>info:eu-repo/semantics/openAccess</dc:rights>
      <dc:rights>Attribution-NonCommercial-NoDerivatives 4.0 Internacional</dc:rights>
      <dc:publisher>Springer Nature</dc:publisher>
   </ow:Publication>
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