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New FDA draft guidelines aim to protect children participating in clinical trials

For immediate release:

Today, the U.S. Food and Drug Administration released draft guidelines that, when finalized, will provide the agency’s perspective on ethical considerations for including and protecting children in clinical trials. The draft guidelines are intended to assist industry, sponsors and Institutional Review Boards (IRBs) when considering the enrollment of children for clinical investigations of drugs, biologics and medical devices.

“Children need access to safe and effective medical products and healthcare professionals need data to make evidence-based decisions when treating children. However, children are a vulnerable population who cannot provide consent for themselves and who benefit from additional safeguards when participating in a clinical investigation,” said Dionna Green, MD, director of the Office of Pediatric Therapeutics at the FDA. “The best way to provide children with safe and effective treatment options is to include them in clinical research and provide those additional safeguards to protect them during clinical trials.”

Historically, children were not included in clinical trials due to a misperception that excluding them from research actually protected them. This resulted in many FDA-approved, licensed, licensed, or cleared drugs, biologics, and medical devices lacking pediatric-specific labeling information. If the medical product was the best available treatment option for the child, doctors had no choice but to use a product whose safety and effectiveness in children had not been reviewed by the FDA. . It has become clear that children can be better protected by including them in clinical research.

The draft guidelines, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children,” describe the ethical framework for protecting children in clinical research, which includes risk and benefit considerations. The draft guidelines describe and explain fundamental concepts of the ethical framework that IRBs, sponsors and industry should consider when reviewing or conducting clinical trials involving children, including:

  • Scientific need to conduct a clinical investigation in children
  • Risk categories for interventions or procedures that do not offer the prospect of direct benefit to the child
  • How to assess whether an intervention or procedure offers the prospect of direct benefit to the child
  • Risk assessment for interventions or procedures with a perspective of direct benefit
  • Component analysis of the risks of interventions or procedures
  • Possibility of review, under a regulatory provision, of research that is not otherwise approvable by an IRB
  • Parental or guardian authorization and child’s consent

The public can provide comments on draft guidance. All comments should be submitted within 90 days to ensure the agency considers them when finalizing the draft guidelines. The FDA remains committed to protecting children in clinical trials and to ensuring the safety and effectiveness of medical products intended for children.

The guidelines were developed by the FDA’s Office of Pediatric Therapeutics with input from the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health.

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The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.


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