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International Multi-stakeholder Consensus Statement on Clinical Trial Integrity
  • Cairo Consensus Group on Research Integrity ,
  • Khalid S Khan
Cairo Consensus Group on Research Integrity

Corresponding Author:[email protected]

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Khalid S Khan
University of Granada
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Background: Science integrity initiatives require specific recommendations for randomised clinical trials (RCT). Objective: To prepare a set of statements for RCT integrity through an international multi-stakeholder consensus. Methods: Following prospective registration (https://osf.io/bhncy, https://osf.io/3ursn), the consensus was developed via: multi-country multidisciplinary stakeholder group composition and engagement; evidence synthesis of 55 systematic reviews concerning RCT integrity; anonymised two-round modified Delphi survey with consensus threshold based on the average percent of majority opinions; and, a final consensus development meeting. Results: There were 30 stakeholders representing 14 countries from 5 continents including trialists, ethicists, methodologists, statisticians, consumer representative, industry representative, systematic reviewers, funding body panel members, regulatory experts, authors, journal editors, peer-reviewers and advisors for resolving integrity concerns. Delphi survey response rate was 86.7% (26/30 stakeholders). There were 111 statements (73 stakeholder-provided, 46 systematic review-generated, 8 supported by both) in the initial long list, with 8 additional statements provided during the consensus rounds. Through consensus the final set consolidated 81 statements (49 stakeholder-provided, 41 systematic review-generated, 9 supported by both). The entire RCT life cycle was covered by the set of statements including general aspects (n=6), design and approval (n=11), conduct and monitoring (n=19), reporting of protocols and findings (n=20), post-publication concerns (n=12), and future research and development (n=13). Conclusion: Implementation of this multi-stakeholder consensus statement is expected to enhance RCT integrity.
29 Jun 2022Submitted to BJOG: An International Journal of Obstetrics and Gynaecology
05 Jul 2022Submission Checks Completed
05 Jul 2022Assigned to Editor
08 Aug 2022Reviewer(s) Assigned
16 Aug 2022Review(s) Completed, Editorial Evaluation Pending
25 Oct 2022Editorial Decision: Revise Minor
15 Nov 20221st Revision Received
21 Nov 2022Assigned to Editor
21 Nov 2022Submission Checks Completed
21 Nov 2022Review(s) Completed, Editorial Evaluation Pending
21 Nov 2022Reviewer(s) Assigned
24 Jan 2023Editorial Decision: Revise Minor
06 Feb 20232nd Revision Received
09 Feb 2023Assigned to Editor
09 Feb 2023Submission Checks Completed
09 Feb 2023Review(s) Completed, Editorial Evaluation Pending
03 Mar 2023Editorial Decision: Accept