Clinical trials have been a cornerstone of medical research since the mid-18th century, paving the way for groundbreaking treatments and therapies. However, a persistent issue in these trials has been the lack of diversity among participants, potentially limiting the effectiveness and safety of new drugs for various demographic groups. Dr. Robert A. Winn, director of Virginia Commonwealth University’s Massey Cancer Center and president of the Association of American Cancer Institutes, sheds light on this critical issue and discusses efforts to increase diversity in clinical trials on the episode of Radio Health Journal “Don’t Trust the Drugs: The Dangerous Lack Of Diversity In Clinical Trials.”
Why we need diverse clinical trials
The importance of clinical trials in advancing medical treatments cannot be overstated. Dr. Winn emphasizes, “It seems that we are certainly making great progress with clinical trials, and the data would say that there are more people living with cancer than dying from it.” He attributes this progress directly to “landmark clinical trials that has changed the face of breast cancer, that have changed the face of lung cancer and others.”
However, the benefits of these trials have not been equally distributed across all populations. A 2020 FDA report revealed that the majority of research participants are white. Dr. Winn points out, “80 percent of the people in the United States on clinical trials come from a homogeneous background. They’re predominantly white men.” This lack of diversity can lead to significant oversights in drug development and potentially harmful consequences for underrepresented groups.
Real-world consequences: Ambien
The case of Ambien, a popular insomnia medication, serves as a stark example of the importance of diverse representation in clinical trials. In 1992, the FDA discovered a 45% difference in absorption rates between men and women, but initially did not change the dosing recommendations. This oversight led to a rise in car accidents as many female consumers fell asleep behind the wheel. Dr. Winn explains, “You know why that was? It’s because we were giving the wrong dose to women.”
Real-world changes made to clinical trials
To address this issue, Congress recently amended the Federal Food, Drug, and Cosmetic Act to require certain clinical studies to submit a diversity action plan to the FDA. This plan should include enrollment goals for race, sex, ethnicity, and age that reflect the real-world population living with the specific condition being studied.
In addition to regulatory changes, initiatives like the Robert A. Winn Diversity in Clinical Trials Award Program, established by the Bristol Myers Squibb Foundation in 2020, aim to increase diversity in clinical research. The program provides training and research support to selected researchers and offers immersive experiences for medical students in community-based clinical research.
Dr. Winn emphasizes that diversity in clinical trials goes beyond just skin color. It also includes factors such as participants’ locations, socioeconomic status, and access to healthcare. He states, “It boggles my mind why we, as a society, would allow these scientific breakthroughs to only be available to people who can actually afford them in big cities.”
The Winn Awards program focuses on bridging the gap between science and local communities, recognizing that finding a breakthrough treatment is only the first step. Dr. Winn explains, “While the science is good, it’s even better when the fruits of the science can be accessed by all people.” The program teaches researchers how to effectively engage with diverse communities, develop communication skills, and build trust.
This approach not only improves research outcomes but also enhances the patient experience. Dr. Winn notes, “The most surprising thing is to not only to me, but I think to the trainees that participate in this program, is that the getting the science part is hard. But what was actually more interesting and surprising to them is that there was a science to getting it to communities, like rural communities or poor communities or communities of color.”
