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

> **NIH FDA U18** · DUKE UNIVERSITY · 2020 · $3,107,000

## Abstract

Clinical trials have become prohibitively expensive, slow to finish, and have not taken full advantage of
evolving technology, resulting in major gaps in the availability of and knowledge about medical products. The
Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded and hosted by Duke
University and the U.S. Food and Drug Administration (FDA), develops and drives adoption of practices that
will increase the quality and efficiency of clinical trials. For more than ten years, CTTI has informed and
facilitated changes in clinical trial policies and practices.
Duke will continue to support CTTI’s mission through the following specific aims:
(1) Maintain an administrative and scientific infrastructure to implement all related activities under this
collaborative effort.
(2) Identify issues, develop plans, conduct research and activities, and produce recommendations and
resources to improve clinical trials.
(3) Encourage the adoption of recommendations through broad communication activities.
(4) Identify and implement organizational activities to support system change.
To accomplish these aims, CTTI will continue to work with its member organizations and a broader cross-
section of clinical trial stakeholders to develop evidence-based recommendations and resources and support
their adoption. CTTI’s recently refined areas of focus align with the FDA’s priorities and emphasize the
importance of 1) clinical trial quality, 2) patients as equal partners, 3) investigator and site success, 4)
appropriate use of mobile technologies, 5) novel clinical trial designs, and 6) trials that are safe and ethical.
With a focus on these areas, CTTI will advance its vision for a high-quality clinical trial system that is patient-
centered and efficient, enabling reliable and timely access to evidence-based therapeutic prevention and
treatment options.

## Key facts

- **NIH application ID:** 9999499
- **Project number:** 5U18FD005292-07
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** John H Alexander
- **Activity code:** U18 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $3,107,000
- **Award type:** 5
- **Project period:** 2014-09-01 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9999499

## Citation

> US National Institutes of Health, RePORTER application 9999499, Increasing the Quality and Efficiency of Clinical Trials (U18) (5U18FD005292-07). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/9999499. Licensed CC0.

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