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Children in Clinical Trials: FDA’s Proposed Rules of Participation

FDA issued draft guide on ethical considerations and special guarantees for children to participate in clinical trials.

The new statement addresses how to protect children in clinical research for drugs, biologicals, and medical devices. Some of the key concepts that the new guidance included for consideration by industry, sponsors, and institutional review boards (IRBs) were:

  • Scientific need to conduct clinical research in children
  • Risk categories for interventions or procedures that do not offer a 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 intervention procedures with perspective of direct benefit
  • Analysis of components of the risks of the intervention or procedures
  • Potential for review, under regulatory review of research that is not otherwise approved by an IRB
  • Permission of parents or guardians and assent of the child

“Children need access to safe and effective medical products and health professionals need data to make evidence-based decisions when treating children. However, children are a vulnerable population who cannot consent for themselves and extra assurances are given to them when they participate in clinical research,” Dionna Green, MD, director of the FDA’s Office of Pediatric Therapeutics, said in a Press release.

The FDA acknowledged that children had been excluded from trials in the past in the mistaken belief that this would protect them. This has led to many drugs, biologics, and medical devices being put on the market without pediatric-specific labeling, forcing these patients to rely on products believed to be the best available treatment option without the support of a review FDA’s rigorous safety and efficacy test. .

In 2017, the American Academy of Pediatrics considered the unauthorized use of medical devices “often appropriate” in pediatric populations, but urged the generation of more data for pediatric device labeling, especially when it comes to high-risk devices. As candidates for cardiac devices, for example, children may find Size difficulties and anatomical problems..

“The best way to provide children with safe and effective treatment options is to include them in clinical research and provide these extra safeguards to protect them during clinical trials,” Green said.

The FDA’s draft guidance was developed by the agency’s Office of Pediatric Therapeutics with contributions from the Center for Drug Evaluation and Research, the Center for Biological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

The FDA is accepting public comments on the draft for the next 90 days.

  • James Lopilato is a staff writer for Medpage Today. He covers a variety of topics that are being explored in current medical scientific research.

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