International multi-stakeholder consensus statement on clinical trial integrity

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 r...

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Detalhes bibliográficos
Autores: Khan, K.S., Khalaf, Y., Fawzy, M., Chien, P., Bueno-Cavanillas, A., Nuñez-Nuñez, M., Maes Carballo, Marta, Serour, G., Aboulghar, M., ter Riet, G., Zamora, J., Andrews, J., Sallam, H., Wilkinson, J., Abdelghaffar, H., Walczak, J., Wasim, T., Moss, N., Maghraby, H., Zhang, J.J., Mahran, A., Mignini, L.E., Abdelaleem, M., Bedaiwy, M., Hartgerink, C., Sabry, M., AbdelRahman, M.Y., Di Renzo, G.C., Qureshi, Z., Alkhenizan, A., Mortimer, D.
Formato: artículo
Fecha de publicación:2023
País:España
Recursos:Servizo Galego de Saúde (SERGAS)
Repositorio:RUNA. Repositorio da Consellería de Sanidade e Sergas
OAI Identifier:oai:runa.sergas.gal:20.500.11940/21657
Acesso em linha:https://portalcientifico.sergas.gal//documentos/64584d05d30a9139260aeac7
http://hdl.handle.net/20.500.11940/21657
Access Level:acceso abierto
Palavra-chave:Humans
Consensus
Delphi Technique
Peer Group
Research Design
Randomized Controlled Trials as Topic
AS Ourense
HP Verín
Descrição
Resumo: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.

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