a “guinea pig.” It’s hard to change someone’s mind when they’ve seen and experienced things that make them fearful of how they will be treated based on the color of their skin. You can’t brush off those concerns. You have to address them head on with information and education and acknowledge and validate their feelings – and that’s exactly what I did. I had to reassure my father and really make him see that his rights were protected. I also explained to him how laws and standards have been put in place to help protect patients. I was able to help my father address his issues of medical mistrust, which made him more willing to engage with his health care providers.
Can you explain the FDA’s guidance on diversity in clinical trials for those who don’t know?
The U.S. Food and Drug Administration (FDA) issued guidance in 2016 to help ensure that people of different ages, races, ethnic groups and genders are included in clinical trials. While this was an important step toward increasing diversity in clinical trials, there is more progress to be made. For example, in 2019, the FDA approved 48 novel medicines to treat a variety of diseases and health conditions. Of the more than 46,000 participants in the clinical studies of those therapies, only 9% were Black or African American, compared with 72% who were white.1 Those numbers were even more discouraging for clinical trials related to cancer. Of the more than 3,500 patients who participated in clinical trials that led to the approval of 11 new cancer medicines, only 4% were Black or African American compared to 73% who were white.1
In 2022, the FDA expanded their guidance and recommended a proactive plan outlining actions to implement to support the goal of increasing the number of participants from underrepresented racial and ethnic populations in U.S. clinical trials.2
What factors have contributed to lack of diversity in clinical trials?
There are several factors that have contributed to the lack of diversity. To name a few, medical mistrust, language barriers, cultural beliefs, lack of awareness of clinical trials and socioeconomic factors can play a role. Additionally, some may have logistical challenges or financial burdens that may make it more difficult for them to take the time to participate in a clinical trial. Others may be fearful or distrusting of how they will be treated in a clinical trial. In other cases, people simply are unaware that clinical trials may be an option for them. We must act with intention to address the barriers and social determinants of health that limit access to clinical research and novel medicines or vaccines.
What can be done to improve diversity in clinical trials?
The lack of diversity in clinical trials is not a new challenge. My experience in clinical trial site management and clinical trial operations in the pharmaceutical industry has given me a broad view of the complexities involved. I believe a singular approach will not solve the challenge we face today. Rather, this requires collaboration between the pharmaceutical industry and various community organizations, colleges, universities, and professional organizations which engage with diverse groups of people. Together, we can work to address the barriers and social determinants of health that limit access to clinical research studying novel medicines and vaccines.
At Merck, we are working to help historically underrepresented communities access our clinical trials through a variety of activities, including:
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- We use census data to prioritize placement of study sites in communities that have higher populations of people who have historically been underrepresented (e.g., Black Americans).