Women and minorities inadequately represented in clinical trials for novel cardiometabolic drugs

Women and minorities, particularly African Americans, continue to be inadequately represented in clinical trials for novel cardiometabolic medications, with no evidence of improvement in enrollment numbers over the past decade, according to new research published last week in the Journal of the American Heart Association, an open-access journal of the American Heart Association.

Cardiovascular and cardiometabolic (the combination of both cardiovascular and metabolic) diseases are the leading cause of mortality around the world, and Type 2 diabetes increases the risk of cardiovascular disease by about four times in women.

A lack of gender and racial diversity in clinical trials evaluating the safety and efficacy of medications for cardiovascular and cardiometabolic diseases has been a point of concern for researchers. In 1993, the U.S. Food and Drug Administration (FDA) established guidelines to increase the diversity of participants in clinical trials.

In this study, researchers investigated the 10-year participation trends of women and racial and ethnic minorities in pivotal trials supporting the approval of new cardiometabolic medicines. Researchers examined gender and racial/ethnic enrollment data from nearly 300,000 trial participants to assess the proportion of women and minorities.

About 6,000 people participated in each medication trial, on average. The FDA approved 35 new medications during the study period (24 cardiovascular medications and 11 for diabetes from 2008 to 2017).

"Demographic characteristics, such as race and gender, may have contrasting effects on medication response, which may inadvertently lead to variation in treatment outcomes and survival," said Muhammad Shahzeb Khan, M.D., resident in internal medicine at the John H. Stroger, Jr., Hospital of Cook County in Chicago.

"It is important that individuals who participate in these trials are representative of the patients who will be treated with these medicines in clinical practice."

"Unfortunately, we found that the enrollment of women and racial minorities has remained disproportionately low," Khan added.

"The disparities in gender, race, and ethnicity of participants in major clinical trials may have significant implications in determining the effects of these therapies in these groups and may impair generalizability of trial results to routine clinical practice."

The analysis showed that the proportion of women and minorities in clinical trials for FDA approval remained low over time. Researchers found that from 2008-2017:

• Women accounted for only 36% of trial participants;
• Only 4% of trial participants were black/African American;
• Only 12% of trial participants were Asian; and
• Only 11% of trial participants were Hispanic/Latino.

Furthermore, women were underrepresented in research trials for coronary heart disease, heart failure, and acute coronary syndrome compared to the proportion of women in the population who had those diseases.

The study results reinforce the need to increase the representation of all demographic subgroups to ensure variations in outcomes of both benefits and safety are reported. This information is critical so that treatments can be tailored.

While we examined the representation of women and minorities in trials specifically for cardiometabolic medicines, the same principles apply for the ongoing trials of COVID-19 therapies - we need to know which medications work and are safe in all demographic subgroups."

Muhammad Shahzeb Khan M.D, Resident in Internal Medicine, Hospital of Cook County, Chicago

"Therefore, all treatment modalities currently being investigated as potential treatment options for novel coronavirus should be investigated equally among all demographic subgroups, so that any differences in safety and efficacy can be accounted for in advance. The inclusion of diverse participants is essential to a holistic understanding of gender and racial differences in treatment response."

Through its signature, women's initiative, Go Red for Women®, the American Heart Association has advocated for increased representation of women in cardiovascular research studies for nearly two decades.

Go Red for Women's Research Goes Red empowers women to contribute to health research. The initiative has built a community of women scientists, researchers, and medical and health professionals to further raise awareness around women's heart health by closing gender disparity gaps in research and clinical trials.

In light of the COVID-19 pandemic, Research Goes Red expanded its reach and impact through a COVID-19 survey, which launched in May. This survey assesses the top concerns women have related to the health, social, economic, and emotional impact COVID-19 has had on their lives.