Abstract
Background: Science integrity initiatives require specific
recommendations for randomised clinical trials (RCT). Objective: To
prepare a set of statements for RCT integrity through an international
multi-stakeholder consensus. Methods: Following prospective registration
(https://osf.io/bhncy, https://osf.io/3ursn), 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 percent of majority
opinions; and, a final consensus development meeting. Results: There
were 30 stakeholders representing 14 countries from 5 continents
including trialists, ethicists, methodologists, statisticians, consumer
representative, industry representative, 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 8 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.