Historically, children have been excluded from clinical trials for the sole purpose of protecting them. As a result, pediatric-specific labeling information was missing in several FDA-approved medical products, leaving doctors with no choice but to recommend treatment that had not been reviewed for safety and effectiveness in children. It was clear that children needed to be included in clinical trials, but their safety had to be ensured first.
In this regard, the USFDA has released a draft guidance, “ Ethical Considerations for Clinical Investigations of Medical Products Involving Children ,” explaining the ethical fundamentals that need to be considered by industry, sponsors, and institutional review boards (IRBs) while including children in clinical trials. It includes: The scientific necessity of conducting a clinical trial on children Risk categories for procedures or interventions…
