Minorities in clinical trials: Why study populations need to match real-world ones

Clinical trials are vital to medical innovation. Before any drug can be stocked on pharmacy shelves, these studies must occur so researchers can evaluate its safety, efficacy, and impact on individuals with the condition in question. 

For these trials to take place, volunteers must be involved. Recruiting patients for research is one of the first considerations for any medical study, and without participants, medical progress can be hindered. However, for the findings from these trials to be accurate, those who participate must reflect the real-world patient population — unfortunately, that is not always the case.

Who participates in clinical trials?

A low number of patients participate in clinical trials overall. Still, when examining the demographic makeup of those who do enroll, it is clear that people of color are dramatically underrepresented.

As stated by an article in Clinical Informatics News, Black Americans comprise 13.2% of the population but account for just 5% of clinical trial participants. Latinos comprise 16% of the population and just 1% of clinical trial participants. In contrast, 67% of Americans are white yet account for 83% of clinical trial participants overall.

While this points to dangerous disparities across the board, it is an especially dangerous consideration for research on conditions that disproportionately affect people of color, such as lupus, liver disease, and Alzheimer's.

What causes a lack of representation in clinical trials?

The history of clinical trials is fraught with inequality. As Regina Greer-Smith, an engagement activist, shared with us, "People in minority and underrepresented communities lack trust in medical research and the healthcare system. The trust is broken because of historical harm, specifically to the African American and Latino communities. Look at instances such as the US Public Health Service's Tuskegee Syphilis Study [in which proper treatment was withheld from African American men with syphilis for 40 years]. It's really no wonder our communities are skeptical of research and clinical trials, even today. It's ingrained in us."

Though people of color have traditionally shied away from participating in medical research, recent figures show that distrust of clinical trials is declining. In a Research!America survey, they found that the percentage of minority respondents citing "lack of trust" as a reason for not participating declined by as much as 15 percent among minority groups and the population when compared to the results of a 2013 survey.

As the trust in clinical trials increases, the time is right to continue driving awareness and providing opportunities for minorities to take part in clinical research. With the FDA’s new requirement of Diversity Action Plans, sponsors must clearly take action toward diverse recruitment. Click the button below to learn more about Antidote’s research into this topic and how we can help support inclusive recruiting in clinical trials.