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 |
|---|---|
| Pages (from-to) | 1096-1111 |
| Journal | BJOG: An International Journal of Obstetrics and Gynaecology |
| Volume | 130 |
| Issue number | 9 |
| DOIs | |
| Publication status | Published - Aug 2023 |
Funding
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.