Leaving No Stone Unturned: Nationwide Children’s Joins Children’s Oncology Group Pediatric Early Phase Clinical Trial Network

Leaving No Stone Unturned: Nationwide Children’s Joins Children’s Oncology Group Pediatric Early Phase Clinical Trial Network 1024 683 Natalie Wilson

The Children’s Oncology Group (COG), the world’s largest and most recognized pediatric cancer research collaborative, recently selected Nationwide Children’s Hospital to join its Pediatric Early Phase Clinical Trial Network (PEP-CTN) through a peer review process.

The COG PEP-CTN is a re-iteration of the COG Phase 1/Pilot Consortium and is comprised of 21 core member sites across the United States. While Hematology, Oncology & BMT at Nationwide Children’s has maintained active membership in COG for decades, through the leadership of Myeshia Harmon, MHA, CCRP, director of Clinical Research Operations for the division, Timothy Cripe, MD, PhD, FAAP, chief of the division, and Maryam Fouladi, MD, recently-appointed co-executive director of the Pediatric Neuro-Oncology Program, the hospital has now been added to a select list of additional sites that will join the current PEP-CTN membership in conducting early phase trials and pilot studies.

“COG has been the main source for most of our cancer clinical research trials,” says Mark Ranalli, MD, an attending physician in Hematology, Oncology & BMT at Nationwide Children’s and the Nationwide Children’s site principal investigator for COG. “Our involvement with the PEP-CTN provides us with an exciting opportunity for another layer of collaboration with COG. It will increase our exposure to and interactions with industry sponsors. Most importantly, it will expand our ability to provide state-of-the-art therapy and earlier access to novel agents and combinations to our patients at their home hospital.”

The Division of Hematology, Oncology & BMT at Nationwide Children’s, a National Institute of Health (NIH) designated Comprehensive Cancer Center, is the largest facility of its kind in Ohio and one of the largest in the United States. With inpatient admissions and outpatient visits exceeding 13,000 annually and 74% of eligible oncology patients involved in trials for innovative treatments, it’s also among COG’s leading cancer centers for clinical trial enrollment.

“As one of the larger pediatric cancer programs in the country, we have the  patient volume and operational capacity — physical resources, staff and equipment — necessary for these trials,” says Harmon. “This marks another collaboration that will allow our patients to have access to early phase clinical trials that focus on new therapeutic agents, treatment delivery technologies and radiation treatment strategies.”

The first PEP-CTN studies and trials at Nationwide Children’s are beginning now and over the coming months, with Dr. Ranalli and Harmon overseeing their operations.

In addition to facilitating specialized and complex early phase trials on individual patients, by collaborating with COG disease committees, COG leadership, National Cancer Institute leadership and the pharmaceutical industry, the PEP-CTN can accelerate the development of novel drugs for the treatment of childhood cancer.

“Being involved with the PEP-CTN gives us access to very new agents that most centers will not have access to,” says Harmon. “It gives us greater access to the pharmaceutical industry and what’s coming down the pipeline, as well as opportunities to develop our own in-house therapies and trials.”

Affiliation with this group complements existing collaborative relationships between Nationwide Children’s and other top cancer research consortia:

  • Beat Childhood Cancer
  • CONNECT (COllaborative Network for NEuro-oncology Clinical Trials)
  • GAIN (Genomic Assessment Improves Novel Therapy)
  • NANT (New Approaches to Neuroblastoma Therapy)
  • NEXT (National Experimental Therapeutics)
  • PBMTC (Pediatric Blood and Marrow Transplant Consortium)
  • PBTC (Pediatric Brain Tumor Consortium)
  • PIDTC (Primary Immune Deficiency Treatment Consortium)
  • PNOC (Pacific Pediatric Neuro-Oncology Consortium)
  • Sunshine Project
  • TACL (Therapeutic Advances in Childhood Leukemia & Lymphoma)

“By joining other consortia and implementing other early phase trials, we’ve grown and demonstrated our expertise in clinical research,” says Harmon.

“Nationwide Children’s is committed to providing the latest state of the art therapy without turning patients away to other facilities,” says Dr. Ranalli. “Pediatric cancer is very rare with roughly 15,000 new diagnoses in children each year in the United States. This means that to treat childhood cancer successfully, you have to be collaborative and innovative.”

“At Nationwide Children’s, the standard of care is clinical trials,” he adds. “Our cure rate is excellent because we leave no stone unturned.”

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