International multistakeholder consensus statement on post-publication integrity issues in randomized clinical trials...

Area of Science:

• Clinical Trials
• Research Integrity
• Publication Ethics

Background:

• The frequency of randomized clinical trial (RCT) retractions following allegations of post-publication misconduct is rising globally.
• This trend necessitates a standardized approach to address integrity concerns and ensure the reliability of published research.

Purpose of the Study:

• To establish an international multistakeholder consensus on managing post-publication integrity concerns specific to randomized clinical trials (RCTs).
• To develop evidence-based policies and guidelines for preventing and investigating misconduct allegations in RCT publications.

Main Methods:

• A prospective registration and evidence synthesis of 89 articles on post-publication integrity concerns.
• A multidisciplinary stakeholder group of 48 participants from 18 countries engaged in a two-round Delphi survey and a hybrid consensus development meeting.
• Consensus was achieved on 84 statements covering various aspects of research integrity, from journal instructions to investigation protocols.

Main Results:

• Consensus was reached on 84 statements after rigorous Delphi surveys and a consensus meeting.
• The statements address general integrity aspects, journal policies, editorial processes, complaint handling, investigation procedures, and sanctions.
• Specific guidance was developed for critical appraisal, systematic reviews of RCTs, and future research recommendations.

Conclusions:

• This international consensus provides a framework for policies aimed at preventing post-publication integrity issues in RCTs.
• The established guidelines will aid in improving the investigation of misconduct allegations, thereby enhancing research integrity.
• The consensus statement serves as a crucial resource for journals, editors, researchers, and institutions involved in RCT publication.