Local Pharmacies and Decentralized Clinical Trials: Q&A with Shelli Pavone

Shelli Pavone
President and co-founder
Inlightened

It’s become increasingly clear that a lack of diversity in clinical trials is a major issue for the pharmaceutical industry. While the problem has been identified, the industry is still struggling to find solutions. Shelli Pavone, president and co-founder of Inlightened, spoke with Pharmaceutical Executive about this issue and the ongoing methods to address it.

Pharmaceutical Executive: Why is there still a lack of diversity in clinical trials?
Shelli Pavone: Unfortunately equity and healthcare have historically not gone hand-in-hand. Despite the fact that many diseases disproportionately impact diverse communities, almost 75 percent of clinical trial participants are white, according to 2020 data from the Food & Drug Administration. This lack of diversity is due to numerous factors including:

• mistrust of clinical research system (due to historical abuses)
• aspects of trial design (such as inadequate recruitment and retention efforts, frequency of study visits, time and resource constraints for participants, transportation and participation conflicting with caregiver or family responsibilities)
• language and cultural differences
• health literacy
• religion
• limited access within the health care system
• lack of awareness and knowledge about what a clinical trial is and what it means to participate

PE: How can the lack of diversity in clinical trials be solved?

Pavone: There are various ways diversity in clinical trials can be solved, including:

• Diversify clinical trial staff - We know that trust is essential to the success of population health, and minority patients benefit from being cared for by minority doctors. The importance of having clinical trial staff with a similar background, empathy for common challenges, and ties to the community cannot be underestimated. This includes principal investigators (PIs), sub-PIs, trial coordinators, and so on. Research shows that physician race influences the race of the clinical trial participants, and trial leadership by minority physicians is well below that observed among white physicians, especially in FDA-regulated clinical trials funded by industry. Affiliated academic, clinical, and industry organizations must commit to enabling more access and opportunity for minority clinicians to work in clinical trials, in order to advance DEI — and the care of — all patients.
• Put tools in place for more equitable and representative enrollment - This starts with centralizing information about trial availability and effective site-based outreach. That includes using digital tools to enhance and enable peer-to-peer outreach and strip down barriers to clinical trial information that exist today. We also need to create a centrally-located clinical trial database, so a patient or provider’s location does not impact whether they have access to information. Lastly, we need tailored outreach plans for all patient populations, so they receive information in their preferred language, via their preferred channels and mediums (e.g., print vs. video) and when they are best suited to consume it. The Digital Medicine Society (DiMe) — and several leading life science and digital health organizations — previously collaborated on a Diversity, Equity, and Inclusion in Digitized Clinical Trials project to develop the best practices needed to harness the promise of digital transformation in clinical trials, for the benefit of all, not just the over-represented few.
• More, continued involvement at the federal level - In 2022, the U.S. Food and Drug Administration took an important step toward increasing racial and ethnic diversity in clinical trials, by issuing draft guidance “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials.” That guidance was updated in June of 2024. Simply stated, it says that meaningful representation of racial and ethnic minorities in clinical trials is fundamental to public health to develop better treatments, and improved ways to combat diseases, especially those that often disproportionately impact diverse communities. This awareness at the federal level, with ways to systematically address the issues, will only continue to help improve it.
• Make clinical trials more accessible - As stated above, lack of access and proximity to clinical trials, as well as language and cultural differences, are a big deterrent for people participating in clinical trials. Innovative industry partnerships are helping to address this by bringing clinical trials to the people - so to speak. As one example, retail pharmacies have started offering clinical trials aimed at redefining the patient experience and addressing access and diversity challenges in healthcare. With a large majority of the U.S. population located in close proximity, initiatives like this make clinical trials much more accessible than ever before. Having them in local communities also ensures more diversity in the trial staff and providers, eliminating potential issues like language barriers and mistrust. Inlightened often partners on such initiatives to source site PIs and sub-Is to oversee the trials.

PE: How do such partnerships come to be?
Pavone: It’s often an introduction to someone overseeing the clinical trials, simply to get to know one another and exchange ideas on healthcare innovation, including new ways to foster diversity in healthcare. Inlightened’s mission of connecting healthcare experts with innovators is often synonymous with site sponsors’ and CROs’ to increase diversity among their trial participants. We typically spend a few months engaging with the team and exploring how our organizations may collaborate effectively. The next step is typically a formal partnership, aligning our strengths to support diversity in clinical trials and advance healthcare innovation.

PE: How will these partnerships work to improve diversity in clinical trials?
Pavone: Improving diversity in clinical trials begins with ensuring diversity within the clinical trial leadership, including Principal Investigators (PIs), Sub-Investigators (Sub-Is), and other staff. Minority communities often harbor distrust of clinical trials, a sentiment that can be mitigated when trial leadership reflects and understands the lived experiences and unique perspectives of those communities.

Through our partnership with clinical trial providers, Inlightened aims to leverage its diverse network of healthcare professionals to place more PIs and Sub-Is from racial and ethnic minority backgrounds into clinical trial leadership. By prioritizing diversity within trial leadership, we can help build trust with historically underrepresented populations, fostering greater engagement and participation in clinical trials. These collaborative efforts not only align with clinical trial providers’ mission but also addresses a critical barrier to achieving equitable representation in clinical research. Ultimately, we believe that increasing diversity among trial staff will serve as a catalyst for more inclusive trials and, by extension, more impactful and broadly applicable healthcare solutions.