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Women and minorities lacking in research and clinical trials for new cardiometabolic medications

 

DALLAS, May 27, 2020 — 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 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 approval of new cardiometabolic medicines. Researchers examined the 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 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 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,” said Khan. “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. Inclusion of diverse participants is essential to 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 their 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.

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Co-authors are Izza Shahid, M.B.B.S.; Tariq Siddiqi, M.B.B.S.; Safi U. Khan, M.D.; Haider Warraich, M.D.; Stephen Greene, M.D.; Javed Butler, M.D., M.P.H., M.B.A.; and Erin Michos, M.D., M.H.S.

The authors noted no sources of funding.

Additional Resources:

  • View the manuscript online
  • AHA’s Research Goes Red
  • AHA News: Women not represented equally in research
  • A Guide to Understanding Clinical Trials
  • Cardiovascular Disease and Diabetes
  • Metabolic Syndrome
  • Follow AHA/ASA news on Twitter @HeartNews
  • Follow news from the Journal of the American Heart Association @JAHA_AHA

Statements and conclusions of study authors published in American Heart Association scientific journals are solely those of the study authors and do not necessarily reflect the Association’s policy or position. The Association makes no representation or guarantee as to their accuracy or reliability. The Association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific Association programs and events. The Association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations and health insurance providers are available at https://www.heart.org/en/about-us/aha-financial-information.

About the American Heart Association

The American Heart Association is a relentless force for a world of longer, healthier lives. We are dedicated to ensuring equitable health in all communities. Through collaboration with numerous organizations, and powered by millions of volunteers, we fund innovative research, advocate for the public’s health and share lifesaving resources. The Dallas-based organization has been a leading source of health information for nearly a century. Connect with us on heart.org, Facebook, Twitter or by calling 1-800-AHA-USA1.

 

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