Despite major policy rollbacks on diversity, equity, and inclusion (DEI) at the US federal level, clinical research leaders have made it clear: inclusive research remains a top priority.
Just days into his presidency, Donald Trump signed an executive order aimed at dismantling DEI initiatives across the US government, with implications for private sector programs as well. However, the commitment to equitable clinical trial enrollment continues to evolve across the research sector.
Go deeper with GlobalData
At the Outsourcing in Clinical Trials East Coast 2025 conference in King of Prussia, Pennsylvania, panelists were asked how trial sponsors and researchers can sustain momentum for inclusive enrollment amid the scaling back of formal DEI mandates.
For Kathleen Cohen, Vice President of Clinical Development Operations at Avalo Therapeutics, the answer lies in adapting without abandoning the mission. “The spirit of what you want to do can still be represented in the organisation you have,” said Cohen. “You can stay on course without using the same dialogue.”
This means continuing to build trust with underrepresented populations and designing studies that reflect the realities of the communities they aim to serve—even if the language around DEI changes.
Practical strategies
Panelists shared a range of strategies being used to support diversity in trial participation, with an emphasis on accessibility, and grassroots engagement. “Find champions and trusted people in the community you want to reach,” advised Lucas Goren, a senior project manager at the Center for Information & Study on Clinical Research Participation (CISCRP).
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalData“Find out who are the pillars of that community and engage with them—they can drive participation and engender trust.” A central tenant of community collaboration is true partnership through reciprocal, enduring relationships, rather than drop-in, ad hoc enrollment farming.
Lay-friendly materials were also highlighted as a vital tool. Goren stressed the need to work with subject matter experts – especially community members – to continuously update and simplify clinical trial language for patients, using plain language definitions and clearly explained study concepts.
Translation was recommended as a key focus and using not just experts, but also members of the target community to review translated content. “You need a second, third, even fourth pair of eyes,” said Goren, underscoring the need for cultural nuance and local context.
Cohen added that materials should be customised to the population a study aims to reach—not only in text but also in visuals.
“Make sure the patient population you are targeting is represented in the text and images of the website,” she said. “Patients feel a connection when they see something that resonates.”
Beyond materials, sourcing new sites in underserved communities is also crucial. Cohen emphasised identifying and partnering with investigators in areas that have historically been overlooked, helping to bring trials closer to those most often excluded.
In concluding remarks, Ram Raju, former SVP of Northwell Health said the spirit of DEI will continue and a shift in attitude is just as important as practical changes.
“These people are not clinical trial subjects—they are your partners,” said Raju. “Change your mindset and focus on trust and transparency. If they believe you, they will stay with you.”
The 16th Annual Outsourcing in Clinical Trials East Coast 2025 (OCT East Coast) is taking place on May 20–21, 2025, at the Valley Forge Casino Resort in King of Prussia, Pennsylvania.
