Pediatricians, researchers and others can weigh in on new draft guidance from the Food and Drug Administration (FDA) that aims to protect children in clinical trials.
The draft guidance, "Ethical Considerations for Clinical Investigations of Medical Products Involving Children," is geared toward industry, sponsors and institutional review boards conducting trials of drugs, biological products and medical devices.
The guidance details considerations around risks and benefits of including children in trials depending on the nature of the trial. The recommendations also cover parent/guardian permission, child assent, design considerations and study procedures.
In the past, many drugs and medical devices were not studied in children due to concerns about the potential harms of including them in clinical research. As a result, many treatment options were not reviewed by the FDA for safety and effectiveness in 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,” FDA Office of Pediatric Therapeutics Director Dionna Green, M.D., said in a press release.
The draft document will be published in the Federal Register on Sept. 26. The public can comment for up to 90 days. Electronic comments can be submitted to https://www.regulations.gov.
