CTTI 2025 Annual Report:
Bridging Vision & Impact
As we reflect on another dynamic year, we are fortunate to be part of CTTI. From our distinct vantage points, we see several factors shaping the clinical trials enterprise:
- Accelerations in federal activities to achieve valuable clinical interventions, fair pricing and affordability, and direct consumer access
- Deceleration of federal investment in scientific and clinical research, economic headwinds, and the offshoring of research investments
- Regulatory focus on transparency, faster development and review, and common-sense flexibility in evidentiary standards
Seizing a transformation of this scale takes collaboration and bold leadership, and throughout the year you, our members, and the broader community brought candor, experience, and creativity to understanding the impacts and opportunities ahead. This report highlights the 2025 conversations you shaped with us and accomplishments you made possible. It also encourages you to think boldly about 2026: What assumptions should we challenge, and what change can we spark together?
With appreciation,
John, Khair, Mark
CTTI Executive Committee Co-chairs
CTTI Leading
Advancing Innovative Solutions
This year, CTTI’s project teams addressed critical quality and efficiency challenges, from streamlining trial design to improving coordination and readiness across clinical trial sectors. With a common-sense ‘totality of evidence’ approach, CTTI is co-creating a research ecosystem that delivers better, faster, and more accessible evidence to improve health for all.
CTTI Community
Convening For Impact
In 2025, CTTI focused on bringing together leaders, patients, and partners for a series of high-impact convenings, including the inaugural State of Clinical Trials meeting, two salon dinners, the fall Steering Committee meeting, and a second AI convening with the FDA. Across these forums, participants tackled urgent challenges and opportunities in clinical research, from real-world data and decentralized models to AI integration, safety reporting, and regulatory modernization. Given evolving national priorities and rapidly advancing technological capabilities, we focused on creating connections across organizations and disciplines to spark new ideas and enhance collective learning.
CTTI Directions
Looking Ahead
In the year ahead, CTTI’s work will be guided by key questions that define the future of evidence generation: How will AI/ML reshape clinical development? How can every involved party accelerate uptake of common-sense regulatory flexibilities? How do we design studies that satisfy country-level enrollment expectations, maintain sufficient generalizability, and still go fast? By confronting these critical and urgent questions together, CTTI members and the broader enterprise are charting the path to a modern evidence generation system.
Driving Change Across Clinical Trials
Since 2007, CTTI has transformed the clinical trials landscape. Through comprehensive recommendations, practical tools, insightful case studies, and impactful publications and presentations, we continue to drive innovation and improve accessibility across the clinical research enterprise.