Minority participation remains low in U.S. diabetes cardiovascular outcome trials
Click Here to Manage Email Alerts
Diabetes cardiovascular outcome trials are enrolling a lower percentage of minority participants than what is reflective of United States’ population, according to a presenter at the virtual Cardiometabolic Health Congress.
“The reason this is so important is because type 2 diabetes disproportionally impacts minority populations,” Leonor Corsino, MD, MHS, associate professor of medicine in the division of endocrinology, metabolism and nutrition at Duke University School of Medicine, told Healio. “I decided to examine this because of my interest in health disparities and the importance of enrolling a diverse population that reflects the population impacted by the disease being studied.”
Corsino said the rising number of minority populations make the issue of enrollment of people from historically disadvantaged backgrounds in trials a large concern. According to U.S. Census data from 2012, 78% of the population was white, while 17% was Hispanic and 13% Black. U.S. Census projections for 2060 have the proportion of white people dropping to 69% and the Hispanic and Black populations increasing to 31% and 15%, respectively. According to the CDC, the prevalence of diabetes is higher in minority populations than in white people.
However, in an analysis of completed and ongoing diabetes and CV outcome trials, Corsino noted many have a limited number of minority participants. This was especially apparent when looking at the number of Black individuals enrolled.
“We know that enrollment of minorities in cardiovascular outcome trials remain low,” Corsino said in the presentation. “This is a big problem for Black participants, where in most trials, the highest enrollment of Blacks was 6.8%.”
Another issue was the lack of reporting on races and ethnicities of participants. Several of the studies Corsino discussed did not report the number of Hispanic or Latino participants.
Corsino noted that reporting data on ethnicity can be challenge for trials enrolling participants from different nations since ethnicity is a U.S. construct. She said this was a reason some studies chose not to report ethnicity. Additionally, data for ethnicity for only participants in the United States is rarely reported.
“When you enroll participants from all over the world, including Latin America, even if you want to aggregate as Hispanic or Latino, for people living in their home country, that is a foreign concept,” Corsino said in the presentation. “So if you ask people, for example, in the Dominican Republic, if you are Hispanic or Latino, most people won’t know what that means and what they will report, most likely, is their race.”
When discussing enrollment specifically in the U.S., Corsino said the lack of minority enrollment is a crucial issue to tackle because the trials included in the analysis helped dictate guidance from organizations such as the American Diabetes Association. Making sure the trials properly reflect the demographics of the U.S. could help provide more accurate outcomes, he said.
"The main goal is to make intentional efforts to enroll participants that reflect the U.S. population, especially in these trials looking at type 2 diabetes, a condition that disproportionally impacts minorities in this country,” Corsino told Healio.
Editor’s Note: This article was updated on Oct. 27, 2020, to make changes requested by Dr. Corsino due to errors in the presentation.
Collapse
Corsino L. Impact of ethnicity and race in cardiometabolic health: Implications for risk assessment and management. Presented at: Cardiometabolic Health Congress; Oct. 21-24, 2020 (virtual meeting).
Read more about
Click Here to Manage Email Alerts