The Role of Pharmacies and Local HCPs in Enhancing Diversity in DCTs
Ramita Tandon
Walgreens
Isaac R. Rodriguez-Chavez
4Biosolutions Consulting
T

he future of clinical trials relies on addressing ways in which we can put diverse patients at the center of the medical product development process. Specifically, we need to listen to the voices of those historically misled and underrepresented in research and demonstrate how clinical trials may be a viable care option. These efforts could directly address the access and diversity issues impacting representativeness in research.

Recently, pharmacy models in clinical research have emerged with quick, specific successes. The latest two FDA guidance documents issued in November 2020 and April 2022 related to diversity in clinical investigations have further validated the need to increase both access and diversity. This article discusses the evolving influence of the pharmacy model and local Healthcare Providers (HCPs) on Decentralized Clinical Trials (DCTs) enabled by Digital Health Technologies (DHTs), exploring key FDA guidance documents for DCTs and diversity initiatives.

The clinical research enterprise, leveraged with local healthcare pharmacy models, involves a partnership in reimagining and enhancing access and care for all. To achieve this, pharmacy models and local HCPs combine their trusted patient relationships, prescription expertise, wellness resources, and community presence with industry-leading partners and capabilities. This helps to deliver a more engaging clinical research and healthcare experience in compliance with the Code of Federal Regulations (21 CFR parts 312 and 800) and in alignment with US Food and Drug Administration (FDA) regulatory guidance documents, such as the draft guidance for Decentralized Clinical Trials (DCTs) issued in May 2023.

Better Diversity in Participation Leads to Better Treatment and Prevention

In the 30 years since the National Institutes of Health (NIH) Revitalization Act of 1993, which directed the NIH to establish guidelines for inclusion of women and minorities in research, there has been progress to improve the participation of women and people of color. However, the FDA has made it clear more is required within each part of the process.

The two latest FDA guidance documents relative to improving diversity in clinical trials mentioned above prompted sponsors to explicitly develop plans to enroll representative numbers of participants from underrepresented populations in clinical trials, such as Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian and other Pacific Islanders, and other persons of color.

Specifically, in the 2022 draft guidance document, the FDA articulated the broader participation in clinical trials and diversity being a major component of a study’s design and strategy, calling out the need for enrollment goals, protocol objectives, and accounting for pharmacokinetic (PK), pharmacodynamic (PD), and pharmacogenomic (PG) variances based on race and ethnicity. We believe that applying a deeper understanding of disease epidemiology, study recruitment considerations, community engagement, patient burdens, and trial conduct outside of traditional models earlier, during study design and strategy, will lead to greater success in diverse participation.

A recent report that reviewed FDA documents for all novel drug approvals from January 2022 through mid-February 2023 (and assigned letter grades to indicate success of diverse participation) revealed that out of 43 novel drug approvals, only 3 of the studies received A grades. Black and Hispanic representation was often inadequate throughout, with 4 drugs receiving a grade of F and 9 approvals having no Black participants in the associated clinical trials. These results are unacceptable and further validate our need to reassess traditional tactics of clinical trial design, recruitment, and conduct in ways that account for culturally specific and real-world experiences.

The Role of Community Pharmacies

The geographic footprint of a pharmacy model is uniquely capable of reaching underrepresented populations. Of the underrepresented populations in clinical trials living within close proximity to a leading national retail pharmacy chain, 89% are African American, 88% Hispanic, and 95% Asian and Pacific Islander. Additionally, pharmacies are in areas with many key indicators across low income, a medium to high social vulnerability index, in underserved areas, and/or in a health professional shortage area. These critical points of healthcare access uniquely position pharmacies to strategically build the right highways to clinical trial access and awareness in the most beneficial places.

Current pharmacy models are already beginning to see results regarding participant recruitment for ongoing clinical trials. In one example, leveraging pharmacy data (including patient proximity and opt-in status for emails and texts) has allowed greater focusing and personalization of engagement efforts for specific patient populations, resulting in almost double the randomized participants rate compared to all other recruitment partners combined. In another trial, the pharmacy’s engagement and recruitment efforts resulted in participant referrals that exceeded the average trial participation amongst Black (from 8% to 17%) and Hispanic (from 11% to 19%) populations.

Agility and Adaptability With DCTs

Some of the tools that can help improve clinical trial access, awareness, and participation are DCT solutions. With DCTs, we can build more agile and adaptable study conditions that are more attractive to participants who are unable to engage in traditionally designed clinical trials.

The cited FDA DCT draft guidance of May 2023 addresses DCT implementation, further legitimizing their application in clinical trials, and laying the foundation for integration, auditing, and inspection of studies that employ any combination of DCTs and nontraditional study sites (e.g., pharmacies, clinics, HCPs, and homes using in-home health services). This guidance provides an avenue for local pharmacies and clinics to invest more deeply in clinical trial awareness and participation initiatives with the understanding that there is an institutional openness from the FDA and sponsors to exploring the opportunities of DCTs.

The guidance also illustrates a shared understanding within the industry that if we want to reach and engage underrepresented populations, we cannot simply keep repeating the same tactics but instead must embrace nontraditional models of clinical trial design, recruitment, and conduct.

Conclusion

The FDA guidance documents illustrate something particularly important to everyone committed to transforming and modernizing the clinical trial industry toward a more efficient and patient-focused enterprise. They exemplify the FDA’s sense that both greater diversity in clinical trials and the implementation of hybrid and full DCT research models are the future of clinical research. Their consensus lays the foundational framework, as well as institutional validation, to explore nontraditional but modernized models of patient awareness, access, outreach, and trial conduct. This opens a world of possibilities to not only the local pharmacies, HCPs, and clinics wanting to offer their patients broader care options , but also to the patients in underserved and underrepresented communities that never would have had the opportunity to participate in a clinical trial. The future is no longer so distant. We need to be bold enough to push forward.
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