FDA promotes children clinical trials for drugs, biological products and medical devices. FDA perspective on the ethical considerations for including and protecting children in clinical trials.
And for that purpose, the draft guidance for children who participate in clinical trials is released which intends to assist industry, sponsors and institutional review boards (IRBs).
Historically, children were not included in clinical trials because of a misperception that excluding them from research was in fact protecting them. This resulted in many FDA-approved, licensed, cleared or authorized drugs, biological products, and medical devices lacking pediatric-specific labeling information.
If the medical product was the best available treatment option for the child, doctors were left with no choice but to use a product that had not been reviewed by the FDA for safety and effectiveness in children. It became clear that children can be better protected by including them in clinical research.
The draft guidance describes the ethical framework for protecting children in clinical research, which includes risk and benefit considerations. The draft guidance outlines and explains fundamental concepts for the ethical framework that IRBs, sponsors and industry should consider when reviewing or conducting clinical trials involving children, including scientific necessity of conducting a clinical investigation in children and risk categories for interventions or procedures that do not offer a prospect of direct benefit to the child.
The public can provide comments on the draft guidance. Any comments should be submitted within 90 days to ensure that the agency considers them when finalizing the draft guidance. The FDA remains committed to protecting children in clinical trials and assuring the safety and effectiveness of medical products for children.
