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

Area of Science:

• Clinical Trials Methodology
• Patient and Public Involvement (PPI)
• Health Services Research

Background:

• Patient and Public Involvement (PPI) is established in UK clinical trials but rarely includes Independent Data Monitoring Committees (IDMCs).
• There is limited evidence on how to effectively include the public in IDMC meetings and the potential impact of PPI.
• The Southampton Clinical Trials Unit (SCTU) coordinates numerous cancer drug trials with IDMCs and sought to integrate PPI.

Purpose of the Study:

• To establish a feasible process for including public contributors in IDMCs.
• To assess the training and resource needs for public contributors participating in IDMCs.
• To inform others on developing similar PPI initiatives for trial IDMCs.

Main Methods:

• Employed design-based and action research methods to develop initial training.
• Piloted the training in a SCTU cancer trial, gathering feedback from public contributors, trial staff, Chief Investigator, and IDMC chair.
• Refined the training program based on feedback and evaluated it further in three additional trials.

Main Results:

• The developed training was found to be useful and informative for public contributors.
• Public contributors were able to contribute meaningfully to IDMC meetings.
• Feedback facilitated process refinement for wider implementation across SCTU trials.

Conclusions:

• Developed, reviewed, and refined training materials and resources for public contributors in IDMCs.
• Feedback from public contributors, trial teams, and IDMC chairs was largely positive.
• Inclusion of public contributors in IDMCs is feasible and can enhance committee work when adequate training and resources are provided.