# PEP-CTN EHR to RAVE supplement

> **NIH NIH UM1** · PUBLIC HEALTH INSTITUTE · 2021 · $638,499

## Abstract

PEP-CTN Project Summary/Abstract:
The mission of the Pediatric Early Phase Clinical Trials Network (PEP-CTN) is to identify and
develop effective new agents for children and adolescents with cancer, through rational and
efficient clinical and laboratory research. PEP-CTN clinical trials will incorporate correlative
genomics, biology, pharmacology, and imaging studies to further the understanding of the
disposition and action of new agents introduced into the treatment of children with cancer.
Annually, the PEP-CTN will enroll approximately 120 children and adolescents with cancer onto
clinical trials of novel anticancer agents at the 21 core-member sites and 21 non-core member
sites throughout the US, Canada, and Australia. The network institutions are selected through a
peer review process, and serve as a national and international model for new agent development
in pediatric oncology. The PEP-CTN leverages the database infrastructure and resources of the
parent Children’s Oncology Group while maintaining its own administrative and operational
infrastructure to ensure rapid development, implementation, and reporting of specialized and
complex early phase clinical trials. The PEP-CTN has expertise and resources for the conduct of
translational biology, pharmacokinetic, and pharmacogenetic studies, and utilizes state-of-the-art
informatics systems to facilitate the transfer of response and correlative imaging studies for
central review and analyses.
The PEP-CTN's primary specific aims are: 1) To safely and efficiently introduce novel anticancer
agents into the pediatric setting through the conduct of early phase clinical trials; 2) To
expeditiously obtain preliminary efficacy signals through use of phase 2 expansion cohorts and
pilot studies in order to inform tumor specific trials that will be conducted across COG sites; 3) To
perform genomic analyses, including single gene studies or gene panels, to identify appropriate
patients for early phase studies of targeted agents; 4) To identify associations of tumor
characteristics with response to new agents using genomic analyses such as whole exome
sequencing and RNA sequencing; 5) To incorporate pharmacologic and biologic endpoints,
including circulating tumor DNA, other translational laboratory studies, and imaging modalities,
into early phase studies, in order to enhance our understanding of the new agents and their effect
on tumors.. Development of targeted therapy for childhood cancer is a high priority as it offers the
prospect of more efficacious and less toxic therapeutics.

## Key facts

- **NIH application ID:** 10440223
- **Project number:** 3UM1CA228823-04S1
- **Recipient organization:** PUBLIC HEALTH INSTITUTE
- **Principal Investigator:** Brenda J. Weigel
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $638,499
- **Award type:** 3
- **Project period:** 2018-09-20 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10440223

## Citation

> US National Institutes of Health, RePORTER application 10440223, PEP-CTN EHR to RAVE supplement (3UM1CA228823-04S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10440223. Licensed CC0.

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