FDA has published draft guidance to clarify its perspective on including children in clinical trials.
The agency notes that it wrote the draft guidance to help industry, sponsors and institutional review boards (IRBs) protect children in clinical studies testing drugs, biological products and medical devices.
The draft guidance is titled “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.”
It includes an ethical framework to safeguard children in clinical research. It provides recommendations for ethical frameworks for IRBs, sponsors and industry. In particular, the document includes information on evaluating whether an investigational therapy is likely to offer a prospect of direct benefit to a child. It also provides an assessment of risk for interventions with the potential of direct benefit and protocols for obtaining permission from a parent or guardian and consent from a child.
FDA’s Office of Pediatri…