Each year in October, the Innovation Network Gathering brings together clinical research senior leaders, innovators, and decision-makers focused on how to anticipate, shape, and operationalize the future of clinical trials.
This year, ACRO’s former executive director, Doug Peddicord, moderated the Navigating the Rapidly Evolving Regulatory Landscape panel with former FDA Acting Commissioner Janet Woodcock, ACRO board member Catherine Gregor of Florence Healthcare, and Former FDA Acting Associate Commissioner for Minority Health and Deputy Office Director, Christine Lee Flemming. The panel focused on the systemic challenges slowing clinical trials in the U.S. and the need for greater expertise, coordination, and investment across the ecosystem.
Challenges included:
- Government and FDA operations: Bureaucracy, hiring challenges, and limited expertise are hindering effectiveness. Restoring stability, reliability, and predictability at the FDA is critical.
- Fragmentation: A disconnect between the healthcare system and clinical research contributes to screening and enrollment challenges, limited trial awareness, and inadequate representation.
- Policy and incentives: Policymakers and regulators need a stronger understanding of the full clinical trial ecosystem and the real-world impact of policy decisions.
- Infrastructure and expertise: Sustainable improvements require long-term investment in U.S. clinical research infrastructure and greater involvement from experienced clinical trialists.
However, panelists left room for optimism, remarking that industry resilience and innovation, with initiatives such as CTTI, as well as advances in science, are providing opportunities to address root causes and build a stronger clinical trial ecosystem.
Overall takeaway: Meaningful progress will require experienced voices at the table, stronger cross-sector coordination, sustained infrastructure investment, and a renewed focus on restoring confidence in the FDA and the broader clinical research system.