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Approximately 20% of the new drugs approved in the last several years have known racial and ethnic differences in disposition. Still, the most recent data snapshot on diversity and inclusion from the U.S. Food & Drug Administration revealed that 75% of participants in drug clinical trials are White.
The statistics prompted the FDA to issue new draft guidance to enroll more participants in clinical trials from underrepresented racial and ethnic subgroups.
“The U.S. population has become increasingly diverse and ensuring meaningful representation of racial and ethnic minorities is fundamental to public health,” says FDA Commissioner Robert M. Califf M.D. “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.”
What will it take to achieve greater diversity in clinical trials and drug development? A recent episode of FinThrive’s Healthcare Rethink podcast explored the topic with guests from Walgreens, who are working to reimagine localized healthcare. According to these industry experts, clinical trial equity requires a blend of access, data, and outreach.
Access: Community-based clinical trials
Most potential clinical trial participants live two hours away from the nearest trial site, which is usually an academic medical center, says Adam Samson, Head of Clinical Delivery Operations for Walgreens.
Samson and his team are changing that, leveraging Walgreens’ 9,000-store footprint to remove the geographical barrier to clinical trial participation. Walgreens locations with a Health Corner in-store clinic offer opportunities to expand and equalize the traditional clinical trial model.
“What’s more flexible than having 78% of the U.S. population within 5 miles of a clinical trial site?” Samson asks. “My role is to really look at our existing footprint and try to find ways to bring clinical trials into communities and offer them to patients that oftentimes wouldn’t have access.”
The first Walgreens-based clinical trials launched in January 2023.
“We’re only four or five months into our clinical trial business, but already we’re able to see quite a clear vision,” Samson says. “I’d love to see us in the next few years really show that we can deliver these trials in a way that is high quality with great patient experience, and to start providing clinical research as a care option across the country.”
Data: Better results with front-end SDOH
The use of socioeconomic data accelerated during the pandemic as providers partnered with service agencies to alleviate the social issues impacting health outcomes. SDOH data can be just as powerful to improve the clinical trial process.
“We can do really cool things through data science to better understand target patient populations for new drugs that are coming out,” Samson notes.
In collaboration with Walgreens’ Health Corners clinics, Samson hopes to leverage data to identify the best locations to bring researchers and trial participants together. The use of data removes speculation from the process, ensuring that efforts and resources are directed where they’ll have the most impact on future therapies and treatments. to identify the best locations to bring researchers and trial participants together. The use of data removes speculation from the process, ensuring that efforts and resources are directed where they’ll have the most impact on future therapies and treatments.
Outreach: Leveraging the patient-pharmacist relationship
Clinical trials are not only investments in the future. They may represent a patient’s best opportunity for treatment. Clinical trials provide access to promising therapies, to skilled medical care from a large team of researchers, and to ongoing in-depth follow up.
Pharmacists are uniquely positioned to connect patients from underrepresented demographic groups to these services.
“Pharmacists are probably more accessible than your primary care physician,” says Falguni Shah, Director of Health Corners Product and Clinical Services for Walgreens. “Pharmacists are in your community. We saw during COVID that pharmacists were first-line defense in terms of vaccinations and testing, [providing] easy, accessible mechanisms for patients and customers to come to our stores to get the services they need.”
Walgreens is mindful of the relationship families have had with the brand for more than 120 years, as well as its responsibility to the approximately 160 million patients who trust its pharmacists for care. Facilitating clinical trials in a way that improves diversity, equity, and inclusion would be a noble expansion of patient-pharmacist relationship.
“Pharmacists should be practicing at the top of their licenses to continue to help keep the population healthy,” Shah says.
Watch the full podcast episode below.
