[International Multi-stakeholder Consensus Statement on Clinical Trial Integrity].

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.