FDA Issues Draft Guidance on Including and Protecting Children in Clinical Trials

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In an effort to ensure the safety and well-being of children involved in clinical trials, the U.S. Food and Drug Administration (FDA) recently issued draft guidance that provides the agency’s perspective on the ethical considerations for including and protecting children in clinical investigations. The draft guidance is intended to assist industry, sponsors and institutional review boards (IRBs) when considering the enrollment of children in clinical investigations of drugs, biological products and medical devices.

Children have historically been excluded from clinical trials for a variety of reasons. In some cases, it was simply because researchers assumed that children would not be able to provide accurate and reliable information. In other cases, exclusion was based on the belief that children were too vulnerable to participate in research, or that their bodies were too different from adults to make research applicable. However, exclusion from research can actually put children at greater risk. If a medical product is approved for use in adults but has not been reviewed by the FDA for safety and effectiveness in children, doctors may have no choice but to use it anyway. Including children in clinical research can help to ensure that medical products are safe and effective for all patients.

The draft guidance, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children,” describes the ethical framework for protecting children in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 The draft guidance outlines and explains fundamental concepts for the ethical framework that IRBs, sponsors and industry should consider when reviewing or conducting clinical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
  • Risk categories for interventions or procedures that do not offer a prospect of direct benefit to the child
  • How to evaluate whether an intervention or procedure offers a prospect of direct benefit to the child
  • Assessment of risk for interventions or procedures with a prospect of direct benefit
  • Component analysis of the risks of interventions or procedures
  • Potential for review, under a regulatory provision, of research that is not otherwise approvable by an IRB
  • Parental or guardian permission and child assent
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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.

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

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