For many years, people from racial and ethnic minority groups have been vastly underrepresented in clinical trials. This is despite the fact that they are affected by many health conditions, such as diabetes and hypertension, at higher rates than other groups. According to the Robert A. Winn Diversity in Clinical Trials Award Program, 80% of individuals participating in clinical trials are white, compared to just 58% of the U.S. population. This disparity has serious consequences for the quality of care that people of color receive.
Dr. Robert Winn, the Director of the Virginia Commonwealth University Massey Cancer Center, commented on the issue, saying: “If you take a look at the national data, the number of people of color involved in clinical trials is incredibly small.” Black Americans make up about 8% of participants in clinical trials but represent 13% of the U.S. population, and Hispanics are 11% of trial participants but 16% of the national population.
Despite being disproportionately affected by certain health conditions, racial and ethnic minorities are underrepresented in clinical trials. According to the Robert A. Winn Diversity in Clinical Trials Award Program, 80% of individuals in clinical trials are white, while only 58% of the US population is white. This lack of diversity in clinical trials negatively impacts the care received by people of color.
Dr. Robert Winn, director of the Virginia Commonwealth University Massey Cancer Center, stated that the number of people of color involved in clinical trials is “minuscule.” Black Americans make up 8% of participants in clinical trials but represent 13% of the US population, while Hispanics account for 11% in trials despite being 16% of the national population.
The absence of diversity in trials affects the information available to patients, caregivers, and physicians regarding the best medication for a particular patient. The lack of representation is largely due to a mistrust of the medical system by minority populations, rooted in historical events such as the Tuskegee Syphilis Study where hundreds of Black men were used for experimentation and research.
Maria Apostolaros, a deputy vice president at PhRMA, a biopharmaceutical research company, and John Damonti, the president of Bristol Myers Squibb Foundation, which focuses on health equity, both agree on the need for diversity in clinical trials. This would help provide more comprehensive and accurate information for everyone involved in the healthcare process.
Despite progress in the health field, discrimination against racial and ethnic minorities continues to be a persistent issue. A study by the Brookings Institute found that over 40% of African Americans, Native Americans, and Latinos have faced unfair treatment in the medical field. The infamous Tuskegee experiment is just one of many examples of past abuse and unethical clinical research in the United States.
However, some doctors assert that the health field has made significant improvements and must address the diversity gap to build trust and provide equal opportunities for all. As Dr. Joshua Budhu, a neurologist at Memorial Sloan Kettering Cancer Center in New York City, pointed out, lack of diversity in clinical trials can result in depriving people of essential therapy and even lead to cost savings.
Dr. Winn echoed the sentiment, stating that the days of using people as guinea pigs without their consent are long gone, and now, efforts are being made to develop trials and therapies that benefit people of color. Despite these efforts, however, mistrust still persists, and it’s crucial to continue addressing the problem of discrimination in the healthcare system.
Clinical trials have the potential to make a significant impact on both the lives and wallets of the public. A study conducted by the University of Southern California in 2022 found that improved diversity in these trials could lead to substantial cost savings. According to Dr. Joshua Budhu of Memorial Sloan Kettering Cancer Center, “health disparities cost trillions of dollars, but just improving clinical trial diversity alone could save billions.” In fact, if only 1% of health disparities were addressed through more diverse clinical trials, it could result in over $100 billion in gains for diseases such as diabetes and heart disease.
Additionally, there has been a recent shift in awareness among pharmaceutical companies regarding the lack of diversity in clinical trials. This came to the forefront in 2020, with the events of the George Floyd murder and the COVID-19 pandemic. As Dr. Winn explains, “pharmaceutical companies had an awakening on the need for diversity in clinical trials.” By prioritizing diversity in these trials, the healthcare industry has the opportunity to not only improve patient outcomes but also achieve significant financial benefits.
The health care industry is taking steps to address the lack of diversity in clinical trials. According to Winn, pharmaceutical companies are allocating more resources and creating positions to prioritize diversity, equity and inclusion in clinical trials. The Food and Drug Administration (FDA) has also released guidelines to increase diversity in clinical trials and has recommended that trials include a Race and Ethnicity Diversity Plan.
FDA Commissioner Robert Califf stated that the FDA will focus on achieving greater diversity to develop better treatments and fight diseases that often disproportionately impact diverse communities.
However, doctors emphasize that it will take a collective effort from all parties involved in the health care industry to reach equity in clinical trials. This includes patient advocacy groups, hospitals, researchers, patients, companies, and the government. Dr. Joshua Budhu believes that a multi-pronged approach is needed to address the issue.