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African-Americans and clinical trials

OW Staff Writer | 8/22/2019, midnight

African-Americans are significantly underrepresented in clinical trials.

A review of documented past medical experimentation and other practices on Blacks reveals abject brutality and unethical medical practices. These experiences may have served to fortify the legacy of African-American mistrust in the medical system, largely culminating in the infamous Tuskegee Syphilis Study.

Four major barriers to participation in clinical trials have been long identified by medical practitioners and scientists that, for generations, have deterred African-Americans from participating in important medical studies that can help prevent many common—yet deadly—illnesses (e.g. high cholesterol, diabetes, high blood pressure, cancer) among this population:

—Lack of awareness about trials;

—Economic factors;

—Communication issues and

—Mistrust.

As in the business sector, greater team diversity can drive better performance. It is equally true that gender diversity can correlate to stronger corporate performance. In the world of clinical trials, diversity is arguably even more important. As recent reports have indicated, the shortage of African-American participation in clinical trials places this population at a distinct disadvantage in terms of preventative care.

Naturally, one would ask: “How do you know whether a therapy that works well for men is equally effective for women?” Or, “How do you know whether a drug that works for Whites works just as well for African-Americans?”

The Centers for Disease Control and Prevention has reported that African-American children are 10 times more likely than White children to die from asthma complications, yet most of the genetic information scientists have on asthma patients doesn’t apply to African-Americans. Diabetes is about three times as prevalent in the African-American community compared to Whites, yet the former group represents less than 3 percent of diabetes trial participants.

Genetic differences in the human body have different reactions to drugs and therapies. Research has shown that certain treatments for Type 2 diabetes, heart disease, hypertension, and a variety of cancer types are not as effective in all populations.

“An unrepresentative ethnic population in clinical trials can hider progress in the development of safe, efficient, and cost-effective therapies for diseases most prevalent among the [African-American] population,” according to Dr. Margaret Juarez of the Network of Ethnic Physicians Organization. This organization has launched a campaign to increase diversity in clinical trials. “This is significant, in that, when scientists create treatments, the ethnic make-up is a factor in how medications respond to the body based on dosage, drug, or another factor altogether.”

Governmental agencies, such as the Food and Drug Administration (FDA), have for years been aware of the lack of diversity in clinical trials.

The FDA is sharing best practices about clinical trial design and recruitment as well as analyzing sub-populations.

The FDA’s Office of Minority Health was created to address the issue of lack of Black participation. They admit solving this dilemma will be a long-term challenge. But it is well worth the effort.

It is well worth the effort.