Pediatric Early Phase Clinical Trials Networks

Clinical researcher shows a tablet to a happy parent and child

About the Pediatric Early Phase Clinical Trials Network (PEP-CTN)

The Pediatric Early Phase Clinical Trials Network (PEP-CTN) was established in 2019 to continue the work of the Children's Oncology Group (COG) phase 1 Consortium. Its primary mission is to identify and develop effective new agents for children and adolescents with cancer, through rational and efficient clinical and laboratory research. The PEP-CTN designs and conducts pediatric early phase trials, including phase 1 trials (often with phase 2 expansion cohorts) and pilot studies of novel agents or regimens to determine their tolerability. These early-phase studies enable promising agents to proceed to definitive phase 3 clinical trials.

PEP-CTN's consortium infrastructure supports early-phase trials, pilot tolerability trials, and pharmacokinetic and biomarker studies for the development of new pediatric anti-cancer agents. COG sites were selected through a peer-review process to participate in PEP-CTN. 21 core sites in the U.S. participate in all PEP-CTN trials; 21 non-core sites in the U.S., Canada, and Australia participate in selected trials. The PEP-CTN Operations and Data/Statistics Center (ODSC) is embedded within the COG ODSC.

The PEP-CTN is supported by NCI cooperative agreement award UM1-CA228823.

Find a PEP-CTN site on the COG PEP-CTN Website.

Logos of 21 member institutions of the PEP-CTN consortium.

Important characteristics of the PEP-CTN include:

Recognition of the need for seamless transitions from phase 1 to phase 2 testing, reflected by the PEP-CTN name, emphasizing "early phase" clinical trials;
Establishment of the Pediatric Early Phase Agent Prioritization Committee (APC) to prioritize agents for evaluation by the PEP-CTN and to expedite the pace at which novel investigational agents enter clinical testing in children with cancer;
Addition of central monitoring for all PEP-CTN clinical trials; and
Incorporation of relevant biological/genomic evaluations to establish eligibility for PEP-CTN clinical trials and/or to facilitate factors determining the activity of agents studied by the PEP-CTN.

About the Pediatric Brain Tumor Consortium (PBTC)

The Pediatric Brain Tumor Consortium (PBTC) is composed of 15 academic centers and children's hospitals located across the United States and Canada which are competitively selected based on their scientific excellence and clinical expertise in pediatric brain tumors. The PBTC's primary objective is to rapidly conduct novel phase I and II clinical evaluations of new therapeutic agents, treatment delivery technologies and radiation treatment strategies in children from infancy to 21 years of age with primary central nervous system (CNS) tumors.