The US Food and Drug Administration (FDA) has released a new draft guidance which is aimed at protecting children who take part in clinical trials.
Developed by the FDA’s Office of Pediatric Therapeutics, the guidance named ‘Ethical Considerations for Clinical Investigations of Medical Products Involving Children’, will also provide the perspective of the agency on the ethical considerations to include children in trials, once finalised.
Industry, sponsors, and institutional review boards (IRBs) will be assisted by this draft guidance while they consider enrolling children in clinical investigations of biological products, drugs, and medical devices.
The Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health contributed to the guidance development.
FDA Office of Pediatric Therapeutics director Dionna Green said: “Children need access to safe and effective medical products and health care professionals need data to make evidence-based decisions when treating children.
“The best way to provide children with safe and effective treatment options is by including them in clinical research and providing these additional safeguards to protect them during clinical trials.”
The guidance also describes the framework to protect children in clinical research, which includes benefit considerations and risk.
IRBs, sponsors, and industry are required to consider fundamental concepts for the ethical framework at the time of reviewing or carrying out clinical trials in children.
These concepts are outlined in the FDA’s latest draft guidance.
Scientific necessity of performing a clinical trial in children needs to be considered, along with risk categories for procedures that do not offer a prospect of direct benefit to the child.
IRBs, sponsors, and industry should also assess the benefits offered by an intervention or procedure to the child and evaluate the risk of interventions or procedures.
Other concepts that need to be considered include component risk analysis of these interventions or procedures, and permission from parents or guardians.
In April this year, the FDA issued new draft guidance on the development of plans to enrol more subjects from underrepresented racial and ethnic populations in the country into clinical trials.