U.S. Policy Is Reshaping Clinical Trials. Are Operations Teams Ready?

Session details:

U.S. policy is rapidly moving from background noise to a core driver of clinical trial execution. Fueled by national security concerns, competition with China, and FDA priorities around U.S. representation, policymakers are pushing for more—and earlier—clinical development to happen domestically. But these ambitions collide with real operational constraints: limited site capacity, high costs, patient access barriers, and growing protocol complexity. In this session, a policy leader embedded within clinical development and clinical trial operations will translate evolving federal and regulatory activity into what it means for clinical operations teams today, and how leaders can proactively shape, not just react to, what comes next. 

Key Takeaways: 

• Policy push to onshore early-phase and first-in-human trials in the U.S.
• Capacity constraints (sites, patients, cost) threaten feasibility
• Increasing FDA focus on U.S. patient representation in trials
• Clinical trial efficiency challenges now a policy priority
• Growing attention to patient access and financial barriers
• U.S.–China dynamics influencing global trial strategy
• Emerging regulatory reforms targeting early development timelines