# Global Pediatric Clinical Trials Network

> **NIH FDA U18** · DUKE UNIVERSITY · 2020 · $500,000

## Abstract

Failure to label devices and therapeutics for children threatens public health. Performing adequate studies for
pediatric labeling, however, poses many challenges. These include a limited number of eligible participants
with the disease; study design and operational inefficiencies; ineffective stakeholder engagement; and lack of a
robust, pediatric-specific global infrastructure for enrollment. To address this critical unmet need, we will
develop the Global Pediatric Clinical Trials Network (G-PCTN), which will support the infrastructure to plan and
execute pediatric clinical trials through collaboration with academia, industry, parent/patient advocacy groups,
and government agencies. G-PCTN will serve as the coordinating resource for pediatric product development
to improve the public health of children. We will utilize the partnership of a fully functioning pediatric clinical
trials network and a collaboration of FDA, academic medical centers, industry, patient and family advocacy
groups, professional societies and other stakeholders. Under the leadership of Principal Investigators (PIs)
Drs. Daniel K. Benjamin, Jr. and Michael Cohen-Wolkowiez, we will establish 3 cores (Network Operations,
Patient Engagement, and Scientific Oversight) and 5 clinical study groups that will focus on design, dosing,
regulatory/pharmacy, network partnerships, and rare diseases. Both PIs bring complementary skills to lead the
network including vision, clinical trial expertise, chairing of large clinical trials networks (National Institute of
Child Health and Human Development Pediatric Trials Network, Clinical and Translational Science Awards
Trial Innovation Center), industry, and government therapeutics development experience, regulatory strategy,
and PK/PD modeling. Together, we will leverage our experience, capacity, regulatory knowledge, and track-
record to establish the scientific, operational, and stakeholder engagement infrastructure to plan and complete
pediatric clinical studies. We will focus on operational efficiencies and network sustainability with early,
systematic, and integrative approaches to pediatric trials. G-PCTN will solidify and expand our established
global research site network, employing its infrastructure and resources to support investigators, sponsors,
patients, and trainees to conduct clinical trials in children. We will focus on the following specific aims 1)
provide strategy and content expertise to increase the success of pediatric product development; 2) provide
education and training on best practices, design, and execution of pediatric trials; and 3) establish and manage
a sustainable network of sites to execute clinical trials in children. As a result of the efforts of our collaborative
G-PCTN, we will establish the required infrastructure to efficiently conduct scientifically sound global pediatric
clinical trials. This new infrastructure will be leveraged by different sponsors to generate regulatory-grade
quality data and im...

## Key facts

- **NIH application ID:** 10264335
- **Project number:** 3U18FD006298-04S1
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** DANIEL K. BENJAMIN
- **Activity code:** U18 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $500,000
- **Award type:** 3
- **Project period:** 2017-09-25 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10264335

## Citation

> US National Institutes of Health, RePORTER application 10264335, Global Pediatric Clinical Trials Network (3U18FD006298-04S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10264335. Licensed CC0.

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