Improving representativeness in trials: a call to action from the Global Cardiovascular Clinical Trialists Forum

Area of Science:

• Cardiovascular Medicine
• Clinical Trial Design
• Health Equity

Background:

• Cardiovascular disease (CVD) randomized controlled trials (RCTs) often lack diverse participants, including older adults, women, and minority groups.
• Treatment effect estimates for CVD therapies are primarily based on studies of White men with fewer comorbidities, impacting evidence generalizability.
• Underrepresentation in trials relative to disease prevalence is a significant issue globally, particularly in low- and middle-income countries.

Approach:

• This review examines barriers and facilitators to trial enrollment and analyzes temporal trends in participant demographics.
• It emphasizes the importance of representativeness for robust and applicable scientific evidence.
• The review proposes actionable strategies to enhance diversity in CVD clinical trials.

Key Points:

• Strategies include minimizing participant research burden through innovative trial designs.
• Inclusive recruitment practices, flexible eligibility criteria, and diverse leadership are essential.
• Building research capacity in underrepresented regions can foster greater participation.

Conclusions:

• Increasing participant representativeness in CVD trials is vital for generating equitable and generalizable evidence.
• Addressing these gaps can reduce knowledge disparities and combat healthcare inequalities.
• A more inclusive trial enterprise can serve as a tool to counter existing health disparities.