International multi-stakeholder consensus statement on patient, carer and public involvement to enhance clinical trial integrity

This is the authors' abstract. We don't add key points for this paper.

BACKGROUND: The recent update of the Declaration of Helsinki has emphasized community engagement and research integrity. Patient, carer and public involvement (PCPI) throughout the research lifecycle of randomized clinical trials (RCTs) can enhance their integrity. However, no specific PCPI guidance exists for trialists. The Cairo Consensus Group on Research Integrity, consisting of 40 stakeholders from 14 countries, developed a statement to address this gap. METHODS: The project was prospectively registered at the Open Science Framework (https://osf.io/fqepb). Based on the findings of a literature review and a stakeholder consultation, an initial long list of recommendations was created. It was submitted to a two-round modified Delphi survey before being finalized in a hybrid online-face-to-face meeting. RESULTS: The modified Delphi survey response rate was 63% (29/46) for the first round, and 65% (30/46) for the second round. The initial long list consisted of 46 statements, and nine additional statements were provided during the consensus process. The final set consolidated 39 statements, grouped into seven categories: General; Design, Approval and Funding; Conduct and Monitoring; Reporting of protocols and findings; Dissemination and Implementation; and Future Research and Development. CONCLUSION: This international consensus statement is expected to help organizations implement PCPI to enhance RCT integrity.