How to make cardiology clinical trials more inclusive

Area of Science:

• Cardiovascular research
• Clinical trial methodology
• Health equity

Background:

• Cardiovascular clinical trials frequently under-represent key demographics like children, older adults, females, and ethnic minorities compared to population disease prevalence.
• This disparity limits the generalizability and applicability of trial findings across diverse patient groups.

Purpose of the Study:

• To outline actionable strategies for enhancing the representativeness of cardiovascular clinical trials.
• To propose improvements across trial funding, design, conduct, and dissemination phases.

Main Methods:

• Review and synthesis of current best practices and proposed interventions for increasing trial diversity.
• Focus on recruitment strategies, site selection, exclusion criteria, pragmatic trial designs (embedded, decentralized), culturally appropriate communication, and co-design with patient representatives.
• Emphasis on diversifying trial leadership and leveraging reporting requirements from funding bodies and journals.

Main Results:

• Enhanced representativeness can be achieved through inclusive recruitment and site selection, minimizing patient burden with pragmatic designs, and culturally tailored communication.
• Engaging diverse patient populations in trial co-design and diversifying trial leadership are crucial for fostering trust and improving participation.
• Increased demand for sociodemographic data reporting by funders and journals, alongside regulatory guidance, can drive progress.

Conclusions:

• Implementing a multi-faceted approach addressing funding, design, conduct, and dissemination is essential for improving cardiovascular trial diversity.
• Diversifying trial participation and leadership is critical for advancing health equity in cardiovascular medicine.
• The proposed strategies offer a transferable framework for enhancing representativeness in clinical research beyond cardiovascular trials.