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Such a scenario is far from rare — and has historically been more pronounced. Despite growing support and regulatory guidance, recent data from the Tufts Center for the Study of Drug Development (CSDD) shows that Black or African American participants represent just 7.3% of clinical trial enrollees, even with decentralized clinical trial (DCT) approaches in place. For context, Black or African American people (including those who identify as Black alone or in combination with other races) represent 14.9% of the total U.S. population according to 2023 Census Bureau data.
Ken Getz
Yet emerging research shows that a more strategic implementation of DCT can meaningfully shift diversity metrics. An analysis by the PACT Consortium, covering 69 clinical trials, reveals that DCTs achieved notably higher participation rates across multiple demographic groups. For instance, 20.9% of participants identified as Asian in DCT‐enabled trials—compared to only 14.2% in more traditional trials—and enrollment of American Indian or Alaska Native participants was nearly quadruple (1.9% versus 0.5%).
Boosting diversity requires a multifaceted approach rather than a monolithic one. “In our research, we’ve seen that certain decentralized elements—like local labs—can dramatically boost enrollment among Black participants,” says Ken Getz, executive director of Tufts. “But you have to be intentional in applying those solutions. It’s not one‐size‐fits‐all.”
The data confirms a need for nuance
While DCT‐enabled trials demonstrated broader overall representation—female participation, for instance, rose to 55.7% compared to 49.0% in traditional trials—the impact varied significantly across demographic groups. This variability supports Getz’s observation that “virtual visits appeal to certain demographics but not others. We have to be more custom and intentional in the way we apply solutions.”
Dr. Pamela Tenaerts
Dr. Pamela Tenaerts, chief scientific officer at Medable, highlights the fundamental shift in trial design needed to sustain these gains: “We realized if you only offer one path to participation—like solely on‐site visits—you end up suppressing some groups. It’s why decentralized, flexible options are essential.”
Such flexibility is especially relevant given new data demonstrating that underrepresented groups enroll at higher rates when multiple engagement pathways—like telehealth, mobile clinics, or local labs—are readily available. A one‐size‐fits‐all model, in other words, can leave behind the very populations most at risk.
Getz underscores how different DCT elements may resonate differently across demographics: “Certain DCT elements improved enrollment among Asian participants but weren’t as appealing for Black participants—and vice versa. For instance, virtual visits really helped some populations, while local labs near a patient’s home proved to be a major draw for others.”
A mounting regulatory push—and robust industry backing
A growing regulatory push further underscores why PACT’s findings carry weight. In the U.S., recent FDA draft guidance on Diversity Action Plans demands that sponsors systematically address enrollment of historically underrepresented groups. Globally, the World Health Organization (WHO) has been advocating for more inclusive trials, especially in low‐ and middle‐income countries.
The COVID‐19 pandemic and George Floyd’s death brought simmering disparities into sharp relief. Initial clinical trial protocols for COVID vaccines faced scrutiny for underrepresenting Black, Hispanic, and older adult populations, while the global push for racial justice accelerated calls for equitable health research. “Companies realized during COVID they had to pilot new approaches,” Getz explains. “Now, the FDA’s guidance puts an even brighter spotlight on adopting DCT practices effectively.” By transforming Diversity Action Plans from a recommendation into a legal requirement, the Food and Drug Omnibus Reform Act of 2022 (FDORA) compels sponsors to systematically improve enrollment among historically underrepresented groups.
“It has shifted significantly,” says Getz. “Diversity is now front and center. We also see more focus on rural and underserved communities, where DCT can help improve access.”
According to Getz, many companies remain in “pilot mode” even now, applying telehealth or local labs in select studies while they assess feasibility. But with heightened regulatory pressures, the industry is moving beyond pilots toward more scalable, evidence‐based models. “Companies said they’re doubling down on diversity. They’re not backing off—it’s becoming a cornerstone of their approach.” Tenaerts said.
PACT’s ‘rising‐tide’ approach
The PACT Consortium—managed by Tufts CSDD and backed by over 30 top‐tier pharmaceutical organizations—offers a data‐driven blueprint for action. AbbVie, Amgen, Gilead, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, GSK, Janssen, Novartis, Pfizer, Roche Genentech, and Sanofi contribute financial resources and frontline clinical insights, while the NIH, FDA, and National Cancer Institute provide additional oversight and expertise.
“It’s very much a learning community,” Getz said. “Year One focused on creating consensus definitions and gathering as many trials as possible. We got nearly 70, and some companies are still going. We hope to more than double that next year, and we plan to create a data repository with readouts and visualizations.”
“We had an annual update recently, and members already want to add more variables. Like peeling an onion—every time you pull back a layer, you find new dimensions to explore,” Tenaerts said. “Yes, no paywalls—it’s open. Many participating companies want the entire industry and patients to benefit.”
Expanding the evidence base
As PACT advances, its member companies are fine‐tuning how decentralized elements integrate into study protocols. Rather than layering telehealth or mobile clinics onto conventional structures, consortium participants are redesigning enrollment pathways with underrepresented communities in mind. Tenaerts offers a few operational insights from the consortium’s data:
“Companies think about one‐third of procedures, and over 40% of visits, could be done remotely. Interestingly, many budget extra time for DCT elements, yet some DCT trials actually beat those planned timelines.”
The next phase involves doubling the current trial dataset, enabling more nuanced analyses of how factors like geography, age, and socioeconomic status intersect with decentralized strategies. Tenaerts explains that “Only about 20% of the trials in this dataset are completed, so we don’t have full enrollment data yet.”
Some sponsors also weigh potential returns on investment: Tenaerts points to an earlier analysis indicating up to a 13x ROI for incorporating DCT elements in Phase 2, and around 5x in Phase 3. That initial insight, however, lacked granular data on which specific DCT measures had the most impact—leading to the formation of PACT to dig deeper into these results.
With these findings, PACT members plan to publish practical guidelines, offering sponsors a clearer roadmap for engaging local labs, remote monitoring, and community‐based research facilities. With the support of wide‐ranging partnerships, PACT is fostering an active learning community that shares both data and best practices. Sponsors consult real‐world case studies to see, for instance, how culturally tailored education materials can drastically improve trial interest in Latino communities, or how after‐hours telemedicine visits can accommodate participants working multiple jobs.
Toward a more equitable future
Building on momentum from regulatory agencies and global health authorities, PACT’s core mission aligns with a shifting paradigm: trial sponsors no longer treat demographic diversity as an afterthought. Instead, they are integrating it as a fundamental design principle. Program leaders foresee a future where clinical research extends beyond traditional geographic hubs, tapping into digital tools to engage participants wherever they live. That vision—a future in which every patient can access potentially lifesaving research—may no longer be a distant ideal, but an achievable next step in the evolution of clinical trials.
By striving for more equitable representation, the industry benefits alongside patients. When each subgroup can see data relevant to them—like our hypothetical patient seeking answers on how a breakthrough therapy works in Black women—overall trust and participation improve. It’s a rising tide that lifts all boats, creating a stronger foundation for better outcomes for everyone. “This shouldn’t just be a data‐gathering exercise—it’ll become a learning community where we improve how we implement DCT for the right reasons,” Tenaerts concluded.
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development
