In a polarized political climate, the case for diversity in clinical trials remains urgent. Tegan Mead of Javara explains how inclusive protocols, community trust, and the business case for equity are helping ensure progress continues — despite the challenges.
David Alvaro (DA): Beyond the deliberate, proactive work of engaging overlooked populations, what other changes in clinical research are helping to improve diversity among trial participants?
Tegan Mead (TM): We’re starting to see trial protocols intentionally designed to prioritize diverse patient populations, which is an encouraging shift. There’s also a growing recognition of the role genetic differences play in health outcomes. Some studies now specifically seek participants with genetic markers linked to elevated risk — for instance, of cardiovascular disease — which helps ensure we’re studying the right populations for the right reasons.
Decentralized trial technologies have also made participation easier for some, but they’re not a complete solution. Many underserved communities still lack reliable internet access or smartphones, which limits the effectiveness of purely digital approaches. In those cases, we need to rely on more traditional methods: being physically present in the community, meeting people where they are. That kind of on-the-ground engagement is still essential.
DA: Are there groups you consider particularly underserved or hard to reach in clinical research?
TM: We’ve made significant strides in increasing participation among Hispanic and African American communities, but Indigenous peoples of the Americas remain severely underrepresented. In the U.S., the percentage of Indigenous Americans involved in clinical trials is extremely low; in many cases, they’re not even being approached for participation. There are deep historical reasons for this, including serious breaches of trust in the past, and rebuilding that trust requires a much deeper cultural understanding and sustained engagement.
Many Indigenous communities also rely heavily on traditional healing practices, and there are known genetic differences — like certain variants that affect how drugs like warfarin work — that make their inclusion in research particularly important. Without that representation, we’re missing critical insights.
Pregnant women are another group that continues to be left out. The hesitation is understandable. There’s inherent risk involved, and many expectant mothers are cautious. But without studying these populations, we won’t have the data we need to determine whether medications are safe and effective during pregnancy. Animal models can only tell us so much. In the future, we may be able to use AI-based simulations to help close that gap, but we’re not there yet.
DA: There has been a lot of national pushback against diversity, equity, and inclusion efforts. What impact is this having on the clinical research space and your work in particular?
TM: Honestly, I’m proud of where clinical research stands right now. As an industry, we’ve been moving in the right direction. We were finally getting some of those FDA guidances in line that were going to mandate changes that would get us in the place we should be, and while that is on pause, the momentum had already shifted. And despite the broader political climate, I’ve been encouraged to see sponsors staying the course. Many are still dedicating resources to inclusive protocols and community engagement.
Of course, you can’t satisfy everyone. Large organizations, in particular, have to navigate these waters carefully. But ultimately, actions matter more than messaging. As long as the commitment to inclusion continues, regardless of how it’s labeled, we’re making progress where it counts.
DA: Do you believe there’s a need for industry stakeholders to collectively advocate to policymakers about the importance of inclusion in drug development? And is there a realistic path to making that happen in the near term?
TM: Absolutely, especially when the research community acts collectively. Industrial pharma, with its significant resources, has real influence when it chooses to speak with one voice. There’s definitely an opportunity to engage upstream with policymakers and shape how inclusion is prioritized.
The challenge lies in coordination. Not every pharmaceutical company has the same structure, funding model, or strategic priorities. The same goes for the financial stakeholders behind them. Aligning all of those interests — especially around how much each contributes — is complex. So, while the potential is there, it requires careful, collaborative effort to move forward effectively.
DA: With that in mind, how would you articulate the business case for maximizing diversity and trying to achieve health equity in clinical trials?
TM: At a foundational level, clinical trials continue to face major recruitment challenges. There is simply no justifiable reason to ever exclude entire segments of our population. Broadening participation helps meet enrollment targets more efficiently, but equally important is the potential for improved health outcomes.
Beyond recruitment, there is also a critical safety and efficacy issue. If we don’t test investigational drugs across the full spectrum of the intended patient population, we risk missing how they’ll perform — or underperform — in real-world use. Inclusion isn’t just the right thing to do ethically; it’s essential for generating comprehensive, reliable data that drives sound regulatory decisions and commercial success.
DA: Turning specifically to Javara, how are you leveraging partnerships to ensure diverse patient inclusion, especially when accelerated development timelines and other pressures can make that goal more difficult?
TM: Most stakeholders across the research ecosystem are headed in the right direction, but what truly makes the difference is intentionality. At Javara, we’re very deliberate about how we engage our healthcare partners — and which partners we choose to work with.
We prioritize partnerships with organizations that not only serve diverse patient populations but are also deeply embedded at the local level. When our partners are already doing meaningful work to engage and support their communities, it creates a strong foundation for inclusive research. That kind of alignment is key to achieving both equity and efficiency, especially under tight timelines or other external pressures.
DA: Who do you see as ideal partners for Javara or alternatively, who stands to benefit most from a partnership?
TM: We believe the right partner can take many forms. While multi-specialty groups are a natural fit — given their broad patient reach and infrastructure — we’re open to working with any organization that shares our commitment to inclusion and community engagement. What matters most is alignment in values and a mutual interest in transforming access to clinical research.
We offer flexible service models to meet partners wherever they are — whether they’re already conducting research, new to the process, or looking to reboot after past challenges. Every new partnership brings opportunities to expand into new therapeutic areas. For example, while we’re not currently conducting oncology trials, we’re preparing to add that capability soon.
Looking ahead, we’re particularly excited about new partnerships developing in southern North Carolina and exploratory opportunities in the Midwest. Our Healthcare Alliance continues to grow, and we’re energized by the potential to bring clinical research to more communities nationwide.
DA: Finally, with the new headwinds facing health equity efforts, how do you stay personally motivated?
TM: That’s easy — the patients. I regularly spend time in clinics, engaging with people participating in clinical research. Hearing their stories and learning about their experiences reminds me why this work matters. Most are genuinely grateful for the care they receive and for being seen and heard — often for the first time in a long while.
No matter how challenging the external environment gets, those patient interactions ground me. They’re a powerful reminder that clinical research can truly improve lives. That’s what drives me to keep pushing — to make sure every person, in every community, has the chance to learn about clinical trials and participate if they choose, without having to leave their community to do it.