# Increasing the Quality and Efficiency of Clinical Trials (U18)

> **NIH FDA U18** · DUKE UNIVERSITY · 2024 · $3,000,000

## Abstract

Despite myriad innovations in design, conduct, and supporting technologies, clinical trials are becoming
more complex, keeping them prohibitively expensive and slow. As a result, the clinical trials ecosystem is not
producing evidence about medical interventions fast enough to keep pace with science and improve population
health. There is a continued need for a dedicated convener who understands the entire trials enterprise and
can create the alignment and infrastructure necessary to help all invested parties make vital improvements.
 The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership, co-founded by Duke
University and the US Food and Drug Administration, with a mission to develop and drive the adoption of
practices that will increase the quality and efficiency of clinical trials. For over 15 years, CTTI has successfully
spurred change in the clinical trials enterprise, convening thousands of individuals from over 700 organizations
as thought partners, co-developers, and co-implementers to produce a significant body of work. CTTI has
created and disseminated over 30 sets of evidence-supported, consensus-driven recommendations
addressing critical trial quality and efficiency, alongside more than 80 implementation tools to support
stakeholders in putting best practices into action. CTTI resources have been cited in FDA and global guidance
documents and have inspired smarter, more efficient trial design choices across countless sponsors. CTTI has
also emerged as a north star for the enterprise in the five pillars of its Transforming Trials 2030 vision, which
stipulates that by 2030 trials will be patient-centric and accessible, integrated into healthcare settings, designed
with a quality approach, leveraging all available data, and improving population health.
 CTTI has succeeded in creating a truly inclusive, participatory culture in which the views and interests
of constituents are fairly represented and valued. No one organization can enact systemic change; therefore,
no one organization controls any CTTI activity. By engaging passionate, committed people, project execution is
enhanced, collective ownership of solutions is established, and recommendations are implemented.
 For the 2024-2029 period, CTTI will continue to build on this progress through the following specific
aims: maintain an administrative and scientific infrastructure to implement all related activities under this
collaborative effort; provide leadership in the establishment of goals, coordination across efforts, measurement
of progress, adaptability and resilience to promote the strength and impact of the clinical trials enterprise;
create evidence-based recommendations, implementation resources, and shared knowledge to help interested
parties across the clinical trials enterprise realize the Transforming Trials 2030 vision; and drive innovation
through strategic communication and engagement efforts that support CTTI recommendations, thought
lea...

## Key facts

- **NIH application ID:** 11130563
- **Project number:** 2U18FD005292-11
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** John H Alexander
- **Activity code:** U18 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2024
- **Award amount:** $3,000,000
- **Award type:** 2
- **Project period:** 2014-09-01 → 2029-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11130563

## Citation

> US National Institutes of Health, RePORTER application 11130563, Increasing the Quality and Efficiency of Clinical Trials (U18) (2U18FD005292-11). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11130563. Licensed CC0.

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