International Multi-stakeholder Consensus Statement on Clinical Trial Integrity
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
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 15 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…
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