Representation of women and people of color in clinical trials is crucial

(StatePoint) Cardiovascular diseases and stroke remain leading causes of death worldwide. As researchers work to find new treatments that have the potential to benefit patients, they say that more diversity is needed among participants in clinical trials to advance understanding of these conditions.

“Clinical trials are a cornerstone of medical research and healthcare innovation. They are essential to advancing medical science and ensuring patient safety, and often lead to the development of effective new treatment options. However, it is crucial that they include participants from diverse backgrounds, encompassing a wide range of lived experiences and living conditions, and representing diverse races, ethnicities, ages, genders, and sexual orientations, so that all communities can benefit from scientific advancements,” says Roxana Mehran, MD, FACC, FACP, FCCP, FESC, FAHA, MSCAI, Professor of Medicine in Cardiology and Population Health Science and Policy Professor in Cardiovascular Clinical Research and Outcomes Director of Interventional Cardiovascular Research and Clinical Trials Mount Sinai Health System.

According to research published in JAMA Network Open, women with atrial fibrillation, which is an irregular heart rhythm, face a higher risk of complications, like stroke, compared to men. The American Heart Association reports that cardiovascular disease prevalence remains highest among non-Hispanic Black females and non-Hispanic Black males. Experts believe such gaps in care are partially due to representation in clinical trials. Historically, women and people of color have been underrepresented in cardiovascular research, which has in recent decades, relied primarily on white male study participants.

One program in particular is helping to address gaps in heart disease treatment as the first clinical program to enroll nearly 50,000 patients across three trials. It’s actively recruiting women and members from diverse populations in an effort to ensure its results are inclusive, equitable and relevant for all patients.

The Librexia program is a phase 3 clinical trial investigating a potential new treatment for patients with blood clotting diseases, including acute coronary syndrome (i.e. heart attack), atrial fibrillation and prevention of repeated strokes. The program is designed to find treatment options that can potentially help improve outcomes in a wide range of patients, including underserved populations like women and people of color. To ensure that trial enrollment represents the individuals likely to take the medication, all who meet the criteria are encouraged to explore if the trials are a fit for them. A clinical trial helps advance research that may benefit family members, the community and future generations. To learn more about cardiovascular and stroke trials near you, visit researchincludesme.com.

“Diverse representation in clinical trials can help us better understand the benefits of a particular medication across all segments of the population,” says Dr. Mehran.