# I-ACT for Children, Global Pediatric Clinical Trials Network

> **NIH FDA U18** · INSTITUTE FOR ADVANCED CLINICAL TRIALS FOR CHILDREN, INC. · 2020 · $1,000,000

## Abstract

PROJECT SUMMARY
The pediatric clinical trials enterprise is too slow and expensive and too disconnected from the needs of children.
Nearly 60% of drugs used in children and 90% used in newborns are prescribed off-label. These problems persist
despite a strong regulatory framework for advancing evidence on innovative medical products. Transformation
of the system requires collaboration among public and private stakeholders and innovative reengineering of the
pediatric trials system, including methods to integrate/catalyze existing expertise, resources, and infrastructure.
The Institute for Advanced Clinical Trials for Children (I-ACT), an independent 501(c)3 non-profit, was
launched as the instantiation of the Advisory Report from Critical Path Institute’s Pediatric Trials Consortium.
I-ACT’s mission/vision are fully aligned with the goals of RFA-FD-17-014 and focus on creating an integrated
resource for pediatric product development, with sustainable global infrastructure to support all phases of
pediatric clinical trials. To address the FDA’s call for a Global Pediatric Clinical Trials Network (GPCTN), our
specific aims are: Aim 1 (Strategy & Planning): Provide a multi-stakeholder forum for addressing existing and
future challenges and opportunities in advancing pediatric clinical trials of innovative medicines and devices.
Aim 2 (Tools, Best Practices & Education): Develop, curate, and disseminate tools, knowledge, and best
practices and produce educational materials and programs that advance pediatric clinical trials on innovative
medicines and devices. Aim 3 (Infrastructure & Trials Execution): Create and continuously improve a
sustainable global infrastructure dedicated to rapid and successful execution of pediatric clinical trials of
innovative medicines and devices. These aims subsume the 13 core functions for the GPCTN in the Advisory
Report. I-ACT will lead the Administrative and Strategic Core of the GPCTN, ensuring successful execution
of all network activities. PEDSnet will be the Data and Learning Core. PEDSnet is composed of the nation’s
leading children’s research hospitals and condition-specific networks and provides hundreds of clinical sites and
a resource (5.3M children) for data-driven feasibility and observational studies. Critical Path Institute, will lead
the Regulatory Science Core and projects in key populations (e.g. newborns, rare diseases) and drug
development tools. The National Capital Consortium for Pediatric Device Innovation, funded by FDA, is one
of the strongest and successful pediatric device research networks in the world, and will lead the Device Core.
I-ACT includes numerous global stakeholders whose commitment and expertise are essential GPCTN
resources. The GPCTN will have the capacity to meet the demands of 50% of pediatric trials of innovative
medicines/devices. Our approach will ensure that pediatric plans/protocols are created and conducted to enable
timelier pediatric labeling, with a focus on outcome...

## Key facts

- **NIH application ID:** 9980852
- **Project number:** 5U18FD006297-04
- **Recipient organization:** INSTITUTE FOR ADVANCED CLINICAL TRIALS FOR CHILDREN, INC.
- **Principal Investigator:** CHRISTOPHER B FORREST
- **Activity code:** U18 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $1,000,000
- **Award type:** 5
- **Project period:** 2017-09-25 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9980852

## Citation

> US National Institutes of Health, RePORTER application 9980852, I-ACT for Children, Global Pediatric Clinical Trials Network (5U18FD006297-04). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/9980852. Licensed CC0.

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