Challenges to Creating Diversity in Clinical Trials

Perhaps the most significant barrier to participation is the fact that many groups within the U.S. population lack trust in the healthcare system, and in clinical research in particular. One powerful example is what is known today as “The Syphilis Study at Tuskegee,” or more commonly as “the Tuskegee Experiment.” Beginning in 1932, the U.S. Public Health Service Commissioned Corps in partnership with the historically Black Tuskegee Institute (now Tuskegee University) conducted a long-term study of 600 Black men, two-thirds with syphilis and a third without. The participants did not give informed consent, and those afflicted were not offered penicillin when it became available in the 1940s. When this came to light in 1972, the study was ended, and study survivors as well as their families were provided with ongoing medical care. But over 100 men died of syphilis and related complications who participated in the study. And the consequences of the racist study continue to impact the health of Black Americans, particularly Black men, to this day. Studies have drawn a connection between the decrease in the life expectancy in Black men and the Tuskegee experiment. According to Harvard’s Global Health Institute, the study has been cited as “a source of distrust among African Americans of the medical establishment, challenging efforts to slow the spread of HIV, contain tuberculosis outbreaks, and broaden preventive care.”

Native Americans have similar reasons for distrust. DNA samples given to researchers at Arizona State University in the early 1990s by members of the Havasupai Tribe of northern Arizona for a diabetes research study were later discovered to have been used for additional research on ethnic migration, schizophrenia, and inbreeding. The Havasupai Tribe filed a lawsuit in 2004 arguing that they had not provided informed consent for the additional use of those samples, and that theirDNA samples for diabetes were used for unrelated genetic studies without consent. In 2010, the lawsuit was settled in favor of the Tribe. An understanding of how DNA is perceived by Native Americans was also lacking; genetic material is considered part of a person and is sacred. Following the settlement, the DNA samples were returned for ceremonial burial. Many tribes banned genetic research, and long-standing distrust of the government and of the healthcare industry was reinforced. Meanwhile, the need for Native American representation in clinical research remains of utmost importance. According to the CDC, Native American people have much higher rates of certain cancers than non-Hispanic white people. And the Office of Minority Health in the Department of Health and Human Services reports that in 2018, Native Americans were 50 percent more likely to be diagnosed with coronary heart disease than whites.

The result of these experiences, which continue to resonate to this day, is that many diverse groups in America do not trust the healthcare ecosystem, including pharmaceutical and biotech companies, doctors, and clinical trials. And the long-term outcome is a serious lack of good health in these populations.

The problem can often be a chicken-and-egg scenario. A Black patient with asthma might be offered a new inhaler that’s been approved by the FDA. But if there was only 2% participation by African Americans in the clinical trials, that person might trust that medication less versus one that provides data on how it interacts with their specific lived experience and genetics. Adequate trial representation of a patient community is an important piece of building trust that the drug, device, or diagnostic is going to work for them. But recruiting patients from these communities for trials has many barriers in addition to the cultural norms discussed above. Otherbarriers include geography, socioeconomic status, language, and perhaps most significantly, taking a cookie-cutter approach to engaging with patients. In the next post, we’ll discuss these barriers, and how patient engagement early and often in product development  can make a difference.