TY - JOUR
T1 - International multi-stakeholder consensus statement on clinical trial integrity
AU - Khan, Khalid Saeed
AU - Cairo Consensus Group on Research Integrity
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 - Mahran, Ali
AU - Mignini, Luciano
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 - Early view.
With supplementary files.
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
KW - research integrity
UR - http://www.scopus.com/inward/record.url?scp=85153227241&partnerID=8YFLogxK
U2 - 10.1111/1471-0528.17451
DO - 10.1111/1471-0528.17451
M3 - Article
AN - SCOPUS:85153227241
SN - 1471-0528
SP - 1
EP - 16
JO - BJOG: An International Journal of Obstetrics and Gynaecology
JF - BJOG: An International Journal of Obstetrics and Gynaecology
ER -