Leading The Way

Sparking Action in Trials Diversity

Despite decades of work and recent progress, there remains a need for collective action across sectors and organizations to align on goals for system-wide, sustainable change. To that end, CTTI, FasterCures, a center of the Milken Institute, the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital (MRCT Center), and the National Academies Forum on Drug Discovery, Development, and Translation coordinated a series of convenings in 2023-2024 to align on common goals for improving representation and equitable access in clinical trials that, if effectively addressed, would promote system-level change in the clinical trials enterprise.

In May 2024, we released a roadmap titled Toward a National Action Plan for Achieving Diversity in Clinical Trials, outlining eight domains for future work. Subsequent steps are already underway, including creation of mechanisms by which all organizations can publicly commit to supporting activities.

Image of the Eight Domains, public awareness, community engagement, site enablement, accountability,workforce diversity, comprehensive data, funding, trial participation

In addition to this enterprise-wise agenda, CTTI continues to develop tactical tools for designing and conducting trials. In December 2024, under the leadership of senior project manager Sabrena Mervin-Blake, we kicked off a project to facilitate the successful implementation of diversity action plans. We explored the creation of transparency and visibility across contract research organizations (CROs), site staff, sponsors, and trialists, the ownership of population goals, and the coordination of efforts for impact. This was one of the fastest project teams we've assembled, reflecting the high level of interest in this topic. The project builds on our recommendations and associated maturity model published in 2023 to help organizations create clinical trial research infrastructure that is more responsive to the needs of historically underrepresented populations.

Building Clarity Around AI In Clinical Development

Artificial intelligence (AI) is an important enabler in drug development. While machine learning is not new in this space, over the past few years, with advancing computing abilities and rapid deployment of large language models, we are seeing how AI can touch every part of the lifecycle from discovery to post-market surveillance.

In collaboration with the FDA, we held a hybrid public workshop in August 2024. This workshop was designed to elicit input into the state of the field and included four panel sessions: 1) Optimizing Model Design through Multidisciplinary Expertise, 2) Using the Data We Have, Creating the Data We Need, 3) Model Performance, Explainability and Transparency, and 4) Identifying Gaps, Addressing Challenges and Charting the Path Forward.

Fostering Coordination Across Federal Clinical Trials Investments

In 2024, recognizing the large investment and importance of government entities in funding and shaping clinical research, CTTI co-hosted Imperatives for U.S. Clinical Research Leadership and Coordination with FasterCures, a center of the Milken Institute, the Foundation for the NIH (FNIH), and the Reagan-Udall Foundation. Senior leaders from across the U.S. government, as well as selected key leaders from other sectors, came together to share the myriad initiatives that are underway across the government to build and coordinate clinical research infrastructure and capacity. Meeting attendees articulated priorities for the near term, while laying the groundwork for years to come.

"With the level of investment in trials from industry and from the U.S. government, it's critical to work together to understand where we are succeeding and where we are falling short. Through its leadership on hard problems like representativeness in trials and staying coordinated across agencies, CTTI has never been more relevant."

Esther Krofah, FasterCures