Including patient and public contributors on clinical trial Independent Data Monitoring Committees (IDMCs).

BACKGROUND AND

aimsPatient and public involvement (PPI) is well established in clinical trials and trial oversight groups in the UK. But public contributors are rarely involved in Independent Data Monitoring Committees (IDMCs), meaning there is little or no evidence for how to include the public in these complex meetings or the impact PPI may have. As a Cancer Research UK core-funded clinical trials unit, the Southampton Clinical Trials Unit (SCTU) coordinates numerous phase II and III cancer drug trials with IDMCs. We aimed to establish a process to include PPI in these committees, but first needed to assess the feasibility of including public contributors and determine what training and resources they need to take part. Here we summarise our process of developing these training and resources to inform others who wish to include public contributors onto trial IDMCs. METHODS AND

findingsWe used design-based and action research methods to develop an initial training programme, working with trial managers and statisticians at the SCTU to ensure key elements of the IDMC process were covered and explained. This was piloted in a SCTU cancer trial, and feedback from the public contributor, trial staff, Chief Investigator and IDMC chair was used to refine the process. The programme was then further evaluated in three more SCTU trials, and feedback was again gathered through participant questionnaires. Our findings show that the training was useful and informative for public contributors, allowing them to contribute meaningfully to IDMC meetings, while constructive feedback allowed us to refine the process further for future roll-out across SCTU trials.

conclusionsThe findings of this project allowed us to develop, review and refine the training materials and resources required for public contributors to meaningfully take part in IDMCs. Furthermore, feedback received from public contributors, trial teams and IDMC chairs was largely positive and suggests that the inclusion of public contributors, when adequate training and resources are provided, is feasible, can enhance the work of these committees and is welcomed by those involved. Limitations to the research and future work have been identified to further assess the impact of including public contributors in IDMCs.