The Federal government mandates that all clinical trials collect and report adverse events to ensure patient safety and to provide data to sponsors, regulators, payers, patients, caregivers, and clinicians about treatment effects. The standard practice in oncology trials is for clinicians to grade all adverse events using the NCI’s Common Terminology Criteria for Adverse Events (CTCAE). For symptomatic AEs (e.g., pain, fatigue, anxiety), there is concern that the clinicians’ adverse events grades may not reflect the children’s experiences while undergoing cancer treatment. This presentation will discuss the development of the patient-reported and caregiver-reported versions of the Pediatric PRO-CTCAE measurement system and findings from a longitudinal study that looked at the level of concordance among children, their caregivers, and treating clinicians for reporting symptomatic adverse events.
Dr. Bryce Reeve is a Professor of Population Health Sciences and Professor of Pediatrics at Duke University School of Medicine. He also serves as Director of the Center for Health Measurement since 2017. Trained in psychometric methods, Dr. Reeve’s work focuses on assessing the impact of disease and treatments on the lives of patients and their caregivers.