About CTTI

About CTTI

Modernizing Trials Together

The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership co-founded by Duke University and the U.S. Food and Drug Administration. Since 2007, we’ve been transforming the clinical trials enterprise by developing and driving adoption of high-impact practices that increase the quality, efficiency, and patient-centeredness of clinical research.

CTTI unites more than 500 organizations and a cross-sector member base—including academic researchers, clinical investigators, industry leaders, patient advocates, and regulators—to build a better future for clinical trials.

Our Mission

To develop and drive adoption of practices that increase the quality and efficiency of clinical trials.

Our Vision

A high-quality clinical trial system that is patient-centered and efficient, enabling reliable and timely access to evidence-based prevention and treatment options.

What We Do

CTTI provides a trusted space where partners across the clinical trials enterprise collaborate to:

  • Share best practices
  • Challenge assumptions
  • Co-create actionable, evidence-based solutions
  • Modernize how clinical trials are designed, conducted, and experienced

CTTI Snapshot

  • Founded: 2007
  • Co-founders: Duke University & U.S. FDA
  • Members: 70+ organizations
  • Partners: 500+ across the clinical trials enterprise
  • Focus: Quality, efficiency, and patient-centered research
  • Core Activities: Recommendations, tools, case studies, events, and publications

We Turn Insight into Action by Offering:

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Our Impact

Our work helps streamline research, accelerate innovation, and improve outcomes across the clinical trials enterprise. CTTI’s recommendations and tools have been widely adopted and cited by leading organizations, including the FDA, EMA, and NIH. Real-world success stories are captured in our Building Better Trials: A Case Study Exchange, showcasing the value of CTTI's resources across institutions and trial settings.

Our Values

Actionable Innovation

We focus on practical, forward-thinking solutions that enable progress in trial design, conduct, and oversight.

Collaboration

We create an inclusive forum for open dialogue and co-creation—bringing together research partners and contributors from across the clinical trials community as equals.

Rigor

We apply robust, evidence-based methods to ensure that our work is credible, impactful, and ready for implementation.

CTTI Work

CTTI Projects

The need for better clinical trials has never been clearer. CTTI unites experts across the clinical trials enterprise to identify challenges, exchange ideas, and develop actionable solutions. Through a collaborative, research-driven approach, CTTI creates evidence-based recommendations and tools that enhance trial quality and efficiency today while advancing a bold vision for the future: Transforming Trials 2030.

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CTTI Vision

A Bold Vision for 2030

CTTI is driving a future where clinical trials are more efficient, inclusive, and impactful. As we head toward 2030, we’re setting the course for transformation—championing forward-thinking practices, fostering collaboration, and shaping a research ecosystem that delivers better, faster, and more accessible evidence to improve health for all. 

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