Recruiting African-Americans and other minority populations into clinical trials continues to be a struggle, and it could be costing them their health — if not their life.
With diabetes, the incidence is nearly twice as high in black people as it is in whites. Yet black patients represent only about 5 percent of all those taking part in clinical drug trials, according to a new study in The Lancet Diabetes and Endocrinology.
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Researchers looked at seven diabetes drug trials done since 2008 to test for cardiovascular safety. In five of the trials, black people made up less than 5 percent of the patients.
“In the United States the burden of diabetes and the serious complications associated with it fall unfairly on minorities, particularly African-Americans, yet it appears they are under-represented in clinical trials of new therapies and devices,” study co-author Dr. David Kerr of the William Sansum Diabetes Center in Santa Barbara, California, told the Associated Press.
“If they are excluded they may be exposed to therapies which may not work or could cause harm,” Kerr added. “The therapies are also likely to be expensive and ineffective.”
About 13 percent of African-Americans in the U.S. have diabetes, compared to 7.6 percent of white Americans. Death rates from cardiovascular disease are also disproportionately high among African-Americans, yet the majority of cardiovascular studies in recent decades have focused on white heterosexual males.
The researchers point out that as treatments for type 2 diabetes evolve from a one-size-fits-all approach into precision medicine, it is critical to understand the differences between individuals. Without diversity in these clinical trials, it is tough to fully determine a drug’s potential effect, including differences in cardiovascular outcomes for different racial and ethnic groups.
Diabetes isn’t the only condition for which physicians and researchers are concerned drugs may work differently across ethnicities. Two types of blood pressure drugs have been found to not work as well in black patients as other people, and one medicine for heart failure works very well in black patients but not in white patients, the AP reported.
The lack of diversity in clinical trials has been an ongoing concern and issue for decades, specifically when it comes to African-Americans. A study in the Journal of the National Medical Association in 1996 on participation in stroke trials showed the four main reasons so few blacks take part: lack of awareness about trials, economic factors, communication issues, and mistrust. Sixty-eight percent of respondents in that trial stated they might participate if asked to, with the rationale being to save lives, benefit themselves or others, and obtain free health care and medication.
“However, responses to the open-ended questions indicated that the patients feared clinical trials, did not want to be treated like ‘guinea pigs’ (which they associated with trials), lacked trust in the medical system, and felt blacks were not being approached for enrollment in a proper manner,” the researchers stated. Sadly, it doesn’t appear much has changed in the 20 years since.