Improving the enrollment of women and racially/ethnically diverse populations in cardiovascular clinical trials: An ASPC practice statement

Michos, Erin D.; Reddy, Tina K.; Gulati, Martha; Brewer, LaPrincess C.; Bond, Rachel M.; Velarde, Gladys P.; Bailey, Alison L.; Echols, Melvin R.; Nasser, Samar A.; Bays, Harold E.; Navar, Ann Marie; Ferdinand, Keith C.

Cardiovascular disease (CVD) remains the leading cause of death for both women and men worldwide. In the United States (U.S.), there are significant disparities in cardiovascular risk factors and CVD outcomes among racial and ethnic minority populations, some of whom have the highest U.S. CVD incidence and mortality. Despite this, women and racial/ethnic minority populations remain underrepresented in cardiovascular clinical trials, relative to their disease burden and population percentage. The lack of diverse participants in trials is not only a moral and ethical issue, but a scientific concern, as it can limit application of future therapies. Providing comprehensive demographic data by sex and race/ethnicity and increasing representation of diverse participants into clinical trials are essential in assessing accurate drug response, safety and efficacy information. Additionally, diversifying investigators and clinical trial staff may assist with connecting to the language, customs, and beliefs of study populations and increase recruitment of participants from diverse backgrounds. In this review, a working group for the American Society for Preventive Cardiology (ASPC) reviewed the literature regarding the inclusion of women and individuals of diverse backgrounds into cardiovascular clinical trials, focusing on prevention, and provided recommendations of best practices for improving enrollment to be more representative of the U.S. society into trials.