Through grassroots patient education, local pharmacies serve as a pivotal doorway to improving access to trials.
The lack of diversity in clinical trials is arguably one of healthcare’s most pressing health equity barriers. Certain populations, as defined by demographic factors such as race, ethnicity, sex, gender identity, or age, have been underrepresented in research for decades. That lack in equitable access to breakthrough treatments has significant consequences, as, reportedly, about 20% of drugs have a variation in responses across ethnic group.
Still, among participants in clinical trials for new molecular entities and therapeutic biologics approved in 2020, 75% percent were white, while only 11% were Hispanic, and less than 10% were Black or Asian, according to FDA data. Additionally, exclusions of lesbians and gay men in trials in the US are not uncommon.
In a first, the fiscal year 2023 Omnibus Appropriations bill included clinical trial diversity provisions, making what had previously been suggestions on how developers and researchers might increase diversity, now mandatory. In support, the “clinical trial diversity and modernization” language in the spending package ensures the FDA can carry out its commitment to inclusion.
This bill is a catalyst for widespread change as it requires sponsors to develop and implement diversity action plans for Phase III trials, including sponsors’ goals for enrollment, rationale for such goals, and an explanation of how to meet them. The bill also establishes public workshops to enhance trial diversity and annual summary reports on progress.
I believe community pharmacies have a clear role in this evolution of clinical trials toward a more patient-centric, equitable research enterprise. We can do this through insights-driven patient acquisition at the local level, which can result in real-world insights applied across all trial designs.
One barrier that will undoubtedly continue to arise in reports is enrollment challenges. Community pharmacies, a key and trusted access point to healthcare for all Americans, are optimally positioned to help industry and regulators reach an increasingly diverse pool of participants to be invited and learn about the impact clinical trials can have on their lives.
During the COVID-19 pandemic, which magnified healthcare inequities, we saw first-hand the value of local pharmacies in providing trusted information and high-quality care for patients who needed it most and real-world insights and evidence that helped inform national and local health decisions.
The trusting relationship pharmacists enjoy with their patients, combined with the access to an extensive foundation of patient-authorized clinical data, provides an avenue for proactively matching patient populations of all backgrounds to trials across a range of disease areas.
We must—and will—continue to work hard to create the right highway to bring trials to communities. It is not a one-size-fits-all approach. We continue to face challenges with health, medical, and digital literacy, as well as trust and fear, among all underrepresented groups. However, a key doorway to improving access for patients who have traditionally been left out of research is active community education and engagement, whether directly at home, virtually, or in-person.
In addition to their physical footprint that unlocks grassroots patient education, local pharmacies can be outfitted to be fully compliant to protect research integrity and patient safety and directly engage patients using validated digital platforms. Educating patients at a community level will then hopefully reduce the cycle time from invitation to enrollment in a clinical trial.
Retail pharmacies can also serve as clinical trials hubs, improving access and the patient experience by removing system-level barriers with convenient locations, such as the local pharmacy or at home. Community pharmacies can reach patients in socially vulnerable areas, fostering the ability to provide personalization and last-mile enablement at every step in the trial journey.
Clinical trials are not only a research path, but also a way to get patients in underserved communities into the overall healthcare system, helping to advance treatment options for diverse communities. The more we can enable, engage, and empower, the more likely patients will routinely ask their healthcare providers, whether a pharmacist or doctor, if a clinical trial may be a suitable care option for them.