International multi‑stakeholder consensus statement on clinical trial integrity

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; 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.