The Pediatric Neuro-Oncology Program is strongly supported by two of Johns Hopkins All Children's Hospital's four institutes–the Cancer & Blood Disorders Institute and the Institute for Brain Protection Sciences. Weekly multidisciplinary neuro-oncology tumor boards are held to discuss patient care and clinical trial status.
All faculty in the Pediatric Neuro-Oncology Program are board-certified in their specialties, have grant funding track records, and prior experience as investigators in clinical trials and cohort studies. Dr. Stacie Stapleton has been principal investigator (PI) on 10 investigator-initiated studies and has more than $500,000 total grant funding. The Pediatric Neuro-Oncology Program benefits from being the only pediatric affiliate of the H. Lee Moffitt Cancer Center & Research Institute, the only National Cancer Institute-designated Comprehensive Cancer Center in Florida.
Johns Hopkins All Children's Hospital is a member of the Children’s Oncology Group and participates in studies pertaining to patients with central nervous system tumors. In addition, Johns Hopkins All Children’s has worked with several other multi-institutional consortiums by opening early-phase studies at our institution including:
- Sunshine Project clinical trials and initiatives (full member institution)
- Pediatric Oncology Experimental Therapeutic Investigator Consortium
- Neuroblastoma and Medulloblastoma Translational Research Consortium
- Headstart Studies
Dr. Stapleton has experience as overall study PI with phase 1 multi-institutional studies, including phase 1 studies with additional sites in the state of Florida. When phase 1 studies have not been available, Johns Hopkins All Children’s has used its extensive experience in working with the Food and Drug Administration (FDA) toward opening compassionate use (i.e., single-use) investigational new drug applications.
- The Research Operations Unit (ROU) within the Johns Hopkins All Children’s Clinical and Translational Research Organization (CTRO) provides services for the design and implementation of research studies, including research coordinator and research nurse support.
- The CTRO’s Investigational Drug Services Unit provides investigational drug study set-up, storage, dispensing, and chain-of-custody drug accountability. The Regulatory Affairs/Quality Assurance Unit is responsible for conducting internal monitoring visits on research studies at Johns Hopkins All Children’s, ensures each study is in accordance with Institutional Review Board-approved protocol, established policies/procedures of the hospital, and all state/federal laws/regulations.
- The Clinical Research Unit (CRU), which opened in June 2017, is a four-bed outpatient research unit, designed to optimize the execution of early-phase clinical trials and the conduct of other research-intensive visits (PKs or investigational drug infusions).
- The Johns Hopkins All Children’s neuroimaging department has been active in the design and execution of several investigator-initiated neuroimaging studies. Our neuroradiology team has expertise in the development and application of innovative neuroimaging techniques, many of which are applied in research studies.
- The hospital’s Institutional Review Board (IRB) is responsible for the oversight of all research involving human subjects that is conducted by staff and employees. The IRB reviews and approves all research activities involving human subjects to ensure that the rights, safety and welfare of the participants are protected. The hospital participates in the National Cancer Institute’s Pediatric Central IRB Independent model (CIRB).