International multi‑stakeholder consensus statement on clinical trial integrity
Metadata
Show full item recordEditorial
Springer Nature
Materia
Randomised controlled trials Research integrity
Date
2024-04-05Referencia bibliográfica
Khan, K.S., for the Cairo Consensus Group on Research Integrity. International multi-stakeholder consensus statement on clinical trial integrity. Middle East Fertil Soc J 29, 20 (2024). https://doi.org/10.1186/s43043-024-00171-z
Sponsorship
Beatriz Galindo (senior modality) programme of the Spanish Ministry of Education; Research training fellowship by the Carlos III Research institute (Rio Hortega programme—CM20/00074); Upper Egypt Assisted Reproduction Conference (UEARS); COMSTECH, the Committee on Scientific and Technological Cooperation of a 57-country consortiumAbstract
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; anonymized 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 trialists, 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.