Clinical Trial Inclusivity, Diversity, and Equity in Action

n 2022, FDA’s Draft Guidance on Diversity Plans and passage of the Food and Drug Omnibus Reform Act (FDORA) significantly changed the landscape for diversity and inclusion in clinical trials. In the below interview, Curavit President and Co-Founder Dave Hanaman and Clinical Research Business Development Manager Natalia Husby discuss Curavit’s new Inclusivity, Diversity, and Equity in Action (IDEA) service offering with DIA Scientific Programs Associate Director Tamei Elliott.

“Everyone in industry is on board, in this industry and others, with diversity initiatives across the board. The challenge is: How do you make them real, how do you make them practical, and how do you see the results?” Hanaman explained. “Virtual clinical trials, decentralized clinical trials, at their core, provide significant benefits in pursuing diversity. The statistic often used is that 97% of the people who could participate in a clinical trial are never even exposed to it, and that disproportionately affects people who are socioeconomically, culturally, geographically removed from where trials are typically conducted or recruited.”

“When a sponsor comes to us with a study and they want to understand which populations might be affected, when it comes to the therapeutic area or when it comes to selecting sites whether virtual or hybrid, we look at census data to identify potential locations if they want to focus on a specific group that might be underrepresented in that field of study,” continued Husby. “We’ve been getting to know different community partners and diverse specialized organizations that focus on different groups of people, whether they’re rural communities, or ethnic or racially diverse communities. We recommend them to sponsors so they can better learn how to engage with these communities.”

Watch the interview below.