USA – New FDA guidance offers ethical roadmap for including children in clinical trials

The US Food and Drug Administration (FDA) has issued draft guidance outlining a series of ethical considerations for conducting clinical trials that involve children.

The guidance, published on 26 September 2022, is aimed at assisting industry, sponsors and institutional review boards (IRBs) when conducting or reviewing clinical investigations of drugs, biological products, and medical devices that involve children. It was developed by FDA’s Office of Pediatric Therapeutics with contributions from the agency’s drug, biologics and device centers.

The issue of including children in clinical trials has been challenging for industry as sponsors seek to balance of the need to provide evidence-based information on how medical products impact children with protecting them from potential harm in research studies. (RELATED: Bioethics Council Calls for Reforms for Clinical Trials Involving Children, Regulatory Focus 27 May 2015)…