# Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)

> **NIH NIH U24** · DUKE UNIVERSITY · 2022 · $2,553,706

## Abstract

ABSTRACT
The conduct of clinical trials, particularly in infants and children, is complex, time consuming and expensive.
Much of this inefficiency stems from slow and ineffective trial start-up and conduct. Duke University and
Vanderbilt University propose to develop the Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)
to improve trial efficiencies, reduce the costs of multi-site clinical trials, optimize study quality, and in doing so,
advance health in our country. Duke and Vanderbilt Universities are uniquely poised to establish the Trial
Innovation Center (TIC) infrastructure in response to this CTSA funding opportunity. Duke will leverage the
capacity, track record, and the pediatrics clinical trials program of the world’s largest Academic Research
Organization, Duke Clinical Research Institute (DCRI), with Vanderbilt’s renowned biomedical informatics
enterprise to meld high quality multi-center trial management with sophisticated informatics solutions
supporting trial processes. Duke will capitalize on the world’s largest NIH-sponsored multicenter pediatric
clinical trials program to support research in this underserved population. TRIDENT will not only transform trial
quality and efficiency at CTSA sites, but will leverage TRIDENT infrastructure and resources to reach well
beyond the CTSAs, given DCRI’s established site network throughout the world. To achieve this vision, we will
establish three cores that will develop and implement innovative strategies across the design and conduct of
trials. The Study Design core will use innovative methods and work directly with the CTSA Recruitment
Innovation Centers and study investigators to develop robust protocols and feasible study budgets. The Study
Start-up Core will engage interoperable IT systems, employ standardized study documents, assess site
capabilities, establish Master Clinical Trial Agreements, facilitate e-consent, and oversee a central IRB thereby
improving time to first participant enrolled. The Study Conduct core will then track study progress and quality,
provide regulatory support, and develop materials to maximize public health impact. We will expand RedCap
capabilities to facilitate collection of study documents via a web based portal, and collect, measure and act
upon trial metrics. From the initial design of the trial until dissemination of the results, investigators will be
partnered with operational and research methods experts. This partnership facilitates ongoing innovation via
self-learning and frequent assessment. Key goals of this effort will be to implement a novel multi-site clinical
trials platform combined with state of the art clinical trial operations to increase multi-site trial quality and
efficiency across the CTSA.

## Key facts

- **NIH application ID:** 10440418
- **Project number:** 5U24TR001608-07
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** DANIEL K. BENJAMIN
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $2,553,706
- **Award type:** 5
- **Project period:** 2016-07-01 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10440418

## Citation

> US National Institutes of Health, RePORTER application 10440418, Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT) (5U24TR001608-07). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10440418. Licensed CC0.

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