Senior Leadership Panel: Solving for the US Patient Enrollment Crisis

Session details:

U.S. patient enrollment is rapidly becoming a policy driven challenge, shaped by evolving FDA expectations, administration priorities, and increasing scrutiny of U.S. representation in global clinical trials. This panel will examine how evolving FDA expectations, site infrastructure, and operating models are reshaping U.S. patient enrollment—and what it will take to build scalable, sustainable enrollment approaches across therapeutic areas.

• How are FDA expectations around U.S. patient representation reshaping clinical trials across all therapeutic areas?
• Where is current clinical research policy enabling greater flexibility (e.g., decentralized elements, protocol pragmatism), and where are outdated assumptions still limiting enrollment
• What are some new models that are successful in other regions: coalitions, flexibility in protocol approaches, etc. 
• How could industry collectively grow the U.S. site footprint?
• How can industry create a shared approach to move beyond fragmented solutions toward scalable, sustainable U.S. enrollment