The Clinical Trials Transformation Initiative (CTTI) held a two-day multi-stakeholder expert meeting on Oct. 12 & 21 to discuss the systemic changes needed to ensure that U.S. clinical trials better meet the needs of diverse populations, including racial minorities, ethnic minorities, and women. At the meeting, leaders and key stakeholders from across the clinical trials ecosystem participated in an engaging forum, informative discussions, and lively breakout sessions that shed more light on new solutions for sharing information and ensuring sufficient resource allocation to diversity, equity, and inclusion initiatives.

Meeting attendees also identified some important themes and identified opportunities to increase diversity in clinical trials:

• The benefits are indisputable. Including a diverse population in clinical trials improves the quality of science, enhances patient trust, increases patient recruitment and retention, and improves clinical care for all patients.
• A culture shift is needed. Organizations need to ingrain diversity, equity, and inclusion initiatives into their portfolio-level strategy and within their overall mission. They should foster bi-directional community partnerships and directly engage patients in the design and planning of clinical trials and diversity efforts from the very beginning.
• This is a full group effort. Increasing diversity in clinical trials is a multi-stakeholder effort that will take all groups working together to achieve goals of clinical trial populations representing the populations who are affected by disease.
• There is important work ahead of us. Meeting attendees provided feedback on CTTI’s draft maturity model, helping to create a better public resource. Suggested additions included a focus on values and guidelines that are generalizable to a wide variety of stakeholders, not just industry stakeholders, and more guidance on how organizations can measure their progress through the maturity model.

CTTI is now using these findings – along with other research results and multi-stakeholder discussions – to develop recommendations and resources for release in early 2022. The project team may host additional webinars focusing on case studies and implementation of resources.