International multi-stakeholder consensus statement on clinical trial integrity

Cairo Consensus Group on Research Integrity

doi:10.1111/1471-0528.17451

International multi-stakeholder consensus statement on clinical trial integrity

Cairo Consensus Group on Research Integrity

Metabolism and Systems Science

Research output: Contribution to journal › Article › peer-review

1 Citation (Scopus)

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Abstract

Objective: To prepare a set of statements for randomised clinical trials (RCT) integrity through an international multi-stakeholder consensus.

Methods: 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 percentage of majority opinions; and, a final consensus development meeting. Prospective registrations: (https://osf.io/bhncy, https://osf.io/3ursn).

Results: There were 30 stakeholders representing 15 countries from five continents including triallists, ethicists, methodologists, statisticians, consumer representatives, industry representatives, 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 eight 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.

Original language	English
Journal	BJOG: An International Journal of Obstetrics and Gynaecology
Early online date	16 Apr 2023
DOIs	https://doi.org/10.1111/1471-0528.17451
Publication status	E-pub ahead of print - 16 Apr 2023

Bibliographical note

Funding Information:
KSK is a distinguished investigator at the University of Granada funded by the Beatriz Galindo (senior modality) programme of the Spanish Ministry of Education; MN‐N is granted a research training fellowship by the Carlos III Research institute (Rio Hortega program ‐ CM20/00074); the Cairo consensus group would like to thank the Upper Egypt Assisted Reproduction Conference (UEARS) for its support of this research integrity initiative; the Cairo consensus group would also like to thank COMSTECH, the Committee on Scientific and Technological Cooperation of a 57‐country consortium, for its support of this research integrity initiative. Funding for open access charge: Universidad de Granada / CBUA.

Publisher Copyright:
© 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.

Keywords

randomised controlled trials, research integrity

ASJC Scopus subject areas

Obstetrics and Gynaecology

Access to Document

10.1111/1471-0528.17451Licence: Creative Commons: Attribution-NonCommercial-NoDerivs (CC BY-NC-ND)

KhanK2023InternationalFinal published version, 1.47 MBLicence: Creative Commons: Attribution-NonCommercial-NoDerivs (CC BY-NC-ND)

Cite this

@article{bdc5aaae210a49e19ebf7465b3bf5902,

title = "International multi-stakeholder consensus statement on clinical trial integrity",

abstract = "Objective: To prepare a set of statements for randomised clinical trials (RCT) integrity through an international multi-stakeholder consensus. Methods: 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 percentage of majority opinions; and, a final consensus development meeting. Prospective registrations: (https://osf.io/bhncy, https://osf.io/3ursn). Results: There were 30 stakeholders representing 15 countries from five continents including triallists, ethicists, methodologists, statisticians, consumer representatives, industry representatives, 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 eight 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.",

keywords = "randomised controlled trials, research integrity",

author = "{Cairo Consensus Group on Research Integrity} and Khan, {Khalid Saeed} and Yacoub Khalaf and Mohamed Fawzy and Patrick Chien and Aurora Bueno-Cavanillas and Maria Nu{\~n}ez-Nu{\~n}ez and Marta Maes-Carballo and Gamal Serour and Mohamed Aboulghar and {ter Riet}, Gerben and Javier Zamora and Jeffery Andrews and Hassan Sallam and Jack Wilkinson and Hazem Abdelghaffar and Jacek Walczak and Tayyiba Wasim and Ngawai Moss and Hassan Maghraby and Zhang, {Jun Jim} and Mignini, {Luciano E.} and Mahmoud Abdelaleem and Mohamed Bedaiwy and Chris Hartgerink and Mohamed Sabry and AbdelRahman, {Mohamed Yahya} and {Di Renzo}, {Gian Carlo} and Zahida Qureshi and Abdullah Alkhenizan and David Mortimer",

note = "Funding Information: KSK is a distinguished investigator at the University of Granada funded by the Beatriz Galindo (senior modality) programme of the Spanish Ministry of Education; MN‐N is granted a research training fellowship by the Carlos III Research institute (Rio Hortega program ‐ CM20/00074); the Cairo consensus group would like to thank the Upper Egypt Assisted Reproduction Conference (UEARS) for its support of this research integrity initiative; the Cairo consensus group would also like to thank COMSTECH, the Committee on Scientific and Technological Cooperation of a 57‐country consortium, for its support of this research integrity initiative. Funding for open access charge: Universidad de Granada / CBUA. Publisher Copyright: {\textcopyright} 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.",

year = "2023",

month = apr,

day = "16",

doi = "10.1111/1471-0528.17451",

language = "English",

journal = "BJOG: An International Journal of Obstetrics and Gynaecology",

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TY - JOUR

T1 - International multi-stakeholder consensus statement on clinical trial integrity

AU - Cairo Consensus Group on Research Integrity

AU - Khan, Khalid Saeed

AU - Khalaf, Yacoub

AU - Fawzy, Mohamed

AU - Chien, Patrick

AU - Bueno-Cavanillas, Aurora

AU - Nuñez-Nuñez, Maria

AU - Maes-Carballo, Marta

AU - Serour, Gamal

AU - Aboulghar, Mohamed

AU - ter Riet, Gerben

AU - Zamora, Javier

AU - Andrews, Jeffery

AU - Sallam, Hassan

AU - Wilkinson, Jack

AU - Abdelghaffar, Hazem

AU - Walczak, Jacek

AU - Wasim, Tayyiba

AU - Moss, Ngawai

AU - Maghraby, Hassan

AU - Zhang, Jun Jim

AU - Mignini, Luciano E.

AU - Abdelaleem, Mahmoud

AU - Bedaiwy, Mohamed

AU - Hartgerink, Chris

AU - Sabry, Mohamed

AU - AbdelRahman, Mohamed Yahya

AU - Di Renzo, Gian Carlo

AU - Qureshi, Zahida

AU - Alkhenizan, Abdullah

AU - Mortimer, David

N1 - Funding Information: KSK is a distinguished investigator at the University of Granada funded by the Beatriz Galindo (senior modality) programme of the Spanish Ministry of Education; MN‐N is granted a research training fellowship by the Carlos III Research institute (Rio Hortega program ‐ CM20/00074); the Cairo consensus group would like to thank the Upper Egypt Assisted Reproduction Conference (UEARS) for its support of this research integrity initiative; the Cairo consensus group would also like to thank COMSTECH, the Committee on Scientific and Technological Cooperation of a 57‐country consortium, for its support of this research integrity initiative. Funding for open access charge: Universidad de Granada / CBUA. Publisher Copyright: © 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.

PY - 2023/4/16

Y1 - 2023/4/16

N2 - Objective: To prepare a set of statements for randomised clinical trials (RCT) integrity through an international multi-stakeholder consensus. Methods: 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 percentage of majority opinions; and, a final consensus development meeting. Prospective registrations: (https://osf.io/bhncy, https://osf.io/3ursn). Results: There were 30 stakeholders representing 15 countries from five continents including triallists, ethicists, methodologists, statisticians, consumer representatives, industry representatives, 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 eight 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.

AB - Objective: To prepare a set of statements for randomised clinical trials (RCT) integrity through an international multi-stakeholder consensus. Methods: 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 percentage of majority opinions; and, a final consensus development meeting. Prospective registrations: (https://osf.io/bhncy, https://osf.io/3ursn). Results: There were 30 stakeholders representing 15 countries from five continents including triallists, ethicists, methodologists, statisticians, consumer representatives, industry representatives, 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 eight 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.

KW - randomised controlled trials, research integrity

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U2 - 10.1111/1471-0528.17451

DO - 10.1111/1471-0528.17451

M3 - Article

AN - SCOPUS:85153227241

SN - 1470-0328

JO - BJOG: An International Journal of Obstetrics and Gynaecology

JF - BJOG: An International Journal of Obstetrics and Gynaecology

ER -

International multi-stakeholder consensus statement on clinical trial integrity

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

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