Merck’s Dr. Adrelia Allen emphasizes need for clinical trial diversity, especially for African Americans

NEW ORLEANS – While the ESSENCE Festival of Culture is known for fun times, great food, and link-ups with friends. However, it is a time for poignant conversation. Dr. Adrelia Allen is the Executive Director of Clinical Trial Patient Diversity at Merck, Inc. Merck is a global biopharmaceutical company. Before speaking at the Global Black Economic Forum , Allen discussed how the lack of representation while researching new treatments negatively impact our lives.

First and foremost, clinical trials are research studies that test a medical, surgical, or behavioral intervention in people. These trials are the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device (for example, a pacemaker), is safe and effective in people.

“We know that there are differences in how drugs work in different races,” Allen explained. “And for African Americans, knowing that we have the highest mortality of many diseases and cancers, we cannot wait. So it was definitely imperative for Merck to be here. And when we think about who’s attending ESSENCE, and knowing that [the audience is largely] Black women. When you educate a man, you educate an individual. But when you educate a woman, you educate the entire community.”

How does historical traumas affect participation in clinical trials?

According to a 2021 study by Johns Hopkins Medicine ,  75% of research participants are White. Even though White Americans make up 60% of the United States population. By comparison, 8% of research participants are African-American/Black. Currently,  African-American/Black people are 13% of people in the U.S. There are a lot of historical prejudices, and those traumas do get passed down. Reports and those stories were amplified during the COVID-19 era, when people would bring up the Tuskegee experiment relative to the vaccine.

Allen acknowledged the existence of those traumas. However, there is no solution that directly fits all experiences and conditions.  Most Americans are distrustful of medicine. This is not a Black problem. COVID-19 and the anti-vax sentiment that we all ran up against to tell us enough that it’s not about race. It’s about the conditions, the systems, and the processes of care that failed to speak to the wounds.

She described a moment in which her father, while being diagnosed with prostate cancer, refused to take an MRI. Why? Because it was a trigger for him because of the Tuskegee experiment. He believed that he would be treated as a guinea pig. But, Allen says, the key is building trust.

“Educating and making sure that we’re talking in communities working with trusted voices, because we can’t go in and simply start talking,” Allen explains. “Helping them understand so that they can be the relay for their communities and talking about clinical trials and in that means we are, keeping patients at the center of what we’re doing. And, we make sure we have community advisory boards that we bring and share recruitment materials, protocols, even procedures that are involved with the clinical trial.”

Other Barriers to Entry

Trust is also the vehicle that allows for the doctor-patient relationship to flourish. The doctors will know what trials will be relevant as long as the patient is willing to disclose family histories and so on.

In addition to race, disability and socioeconomic status are factors that play a role in lack of participation. To that end, Congress has passed the Diverse and Equitable Participation in Clinical Trials Act (also known as the DEPICT ACT) in 2022. Allen says the Federal Drug Administration’s guidance is pending. However, she’s looking forward to building Merck’s action plans.

Allen says Merck is working to operate clinical trials at the four historically Black medical schools. Included is Morehouse School of Medicine in Atlanta. These trials will be conducted by investigators and managers of color with participants from underrepresented populations. Additionally, Allen says Merck is also removing financial barriers to reimburse out-of-pocket travel costs for trial participants and providing a solution to ease transportation barriers.

“Although the finalization of the FDA Diversity Action Plan guidance is pending, we are working across our clinical trial sites to implement mandatory, multi-pronged diversity action plans for all late-stage clinical trials,” Allen said. “We are taking concrete steps to help historically underrepresented communities access our clinical trials.”

What’s Next

In the end, no matter the form of medicine that resides in the cabinet, there must be more African-Americans to ensure that drug is going to be safe for us.

“We want to be a part of that,” Allen said while describing the clinical trial process. “The scientific medical innovations that are occurring today are the differences between life and death. Having access to that information is powerful, and we want to have that information before having to make the critical decision.”

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