Centre of Expertise Urban Vitality

International multi-stakeholder consensus statement on clinical trial integrity


<p>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.</p>

Reference Khan, K. S., & Cairo Consensus Group on Research Integrity (2023). International multi-stakeholder consensus statement on clinical trial integrity. BJOG: An International Journal of Obstetrics and Gynaecology, 130(9), 1096-1111. https://doi.org/10.1111/1471-0528.17451
Published by  Urban Vitality 1 August 2023

Publication date

Aug 2023


Khalid Saeed Khan
Cairo Consensus Group on Research Integrity
Yacoub Khalaf
Mohamed Fawzy
Patrick Chien
Aurora Bueno-Cavanillas
Maria Nuñez-Nuñez
Marta Maes-Carballo
Gamal Serour
Mohamed Aboulghar
Javier Zamora
Jeffery Andrews
Hassan Sallam
Jack Wilkinson
Hazem Abdelghaffar
Jacek Walczak
Tayyiba Wasim
Ngawai Moss
Hassan Maghraby
Jun Jim Zhang
Ali Mahran
Luciano Mignini
Mahmoud Abdelaleem
Mohamed Bedaiwy
Chris Hartgerink
Mohamed Sabry
Mohamed Yahya AbdelRahman
Gian Carlo Di Renzo
Zahida Qureshi
Abdullah Alkhenizan
David Mortimer


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