Mistrust in U.S. medical system leads to lack of diversity in clinical trials

For decades, racial and ethnic minorities have been underrepresented in clinical trials even though they are disproportionately affected by several health issues such as diabetes and hypertension. According to the Robert A. Winn Diversity in Clinical Trials Award Program, 80% of individuals involved in clinical trials are white, compared to 58% in the U.S. population as a whole, which negatively affects the care that people of color receive.

“If you look nationally, the number of folk of color [in clinical trials] are minuscule,” said Dr. Robert Winn, director of the Virginia Commonwealth University Massey Cancer Center, to Yahoo News.

Studies estimate that Black Americans make up about 8% of participants in clinical trials but represent 13% of the U.S. population, and Hispanics account for 11% in trials, even though they are 16% of the national population.

“Not having that diversity in clinical trials prevents us from having information that can inform both patients, caregivers, and physicians around the appropriate medication that might be best for a particular patient,” Maria Apostolaros, a deputy vice president at PhRMA, a biopharmaceutical research company, told Yahoo News.

Experts say the lack of diversity in trials is due to “a mistrust of the medical system by many underrepresented minority populations in the United States, and there’s historical sort of events that have caused that,” John Damonti, the president of Bristol Myers Squibb Foundation, which focuses on health equity, told Yahoo News.

The most notable instance of medical racism occurred in 1932 when doctors from the United States Public Health Service embarked on the Tuskegee Syphilis Study in which hundreds of Black men were used as subjects for experimentation and research.

“Tuskegee is just one really terrible example but there have been so many examples of these kinds of abuses and clinical research throughout the years, especially here in the United States,” Dr. Joshua Budhu, a neurologist at Memorial Sloan Kettering Cancer Center in New York City, told Yahoo News.

But some doctors say the health field has changed for the better and the system must close the diversity gap.

“I will tell you that, at least in the health field, we have tightened up that game, people don’t just say we’re going to take your organs, or we’re just going to use you as a guinea pig, those days have been so long gone,” Winn said. “Now that we are creating therapies and creating trials that would also benefit people of color, we still have this leftover mistrust.”

For racial and ethnic minorities discrimination in health care is a problem that still plagues our society today. Over 40% of African American, Native American and Latinos have experienced unfair treatment in the medical field, according to a 2021 study by the Brookings Institute.

Along with a lack of trust, doctors say minorities have trouble getting access to clinical trials. “We’re actually depriving people of first-line therapy,” Budhu said. “One other kind of practical point about why clinical trial diversity is important is that it actually saves lots of money.”

A 2022 University of Southern California study found that clinical trials save lives and money. “Health disparities in general cost trillions of dollars, but just by improving clinical trial diversity, which helps to decrease health disparities, it will actually save billions of dollars,” Budhu said.

"If just 1% of health disparities were alleviated by improved diversity in clinical trials, that would result in more than $40 billion in gains for diabetes and $60 billion for heart disease," Dana Goldman, founding director of the Schaeffer Center for Health Policy and Economics at USC, wrote in an article.

Winn said that in 2020, after the killing of George Floyd and the coronavirus pandemic, pharmaceutical companies had an awakening on the lack of diversity in clinical trials.

“Many more pharma companies, many more academic centers are not only spending more money to address this issue, but they’re creating positions that will keep the focus on diversity, equity and inclusion and the importance of that and its role in clinical trials,” Winn said.

The Food and Drug Administration released additional guidance in 2022 to increase diversity in clinical trials and recommended that all trials submit a Race and Ethnicity Diversity Plan in the early phases of its clinical development.

"Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities," FDA Commissioner Rober Califf, said in a statement.

In the meantime, doctors say that all entities of the health care industry must work together to reach equity in clinical trials. "This means that multiple stakeholders have to come together — patient advocacy groups, hospitals, researchers, patients themselves, companies that may make new medications like pharmaceutical companies or device manufacturers, as well as the federal government," Budhu said. "I think it needs to be a multipronged approach."