There is no blanket prohibition against doing clinical studies in children of any age. Whether it is safe and ethical depends on many things, such as the indication, the amount of data available in adults, and the availability of supporting toxicology. For example, if the indication is a pediatric disease that does not occur in adults to a significant extent and adequate Phase 1 safety in adults has been established, it is perfectly reasonable to begin clinical studies in children, with the appropriate precautions.
If you are pursuing an indication in children, with or without an adult indication, I think it would be good to obtain scientific advice from FDA and EMA and the file a pediatric study plan (FDA) and/or pediatric investigational plan (EMA) for advice on how to proceed. I know that many competent authorities and ECs/IRBs want to see regulatory concurrence when starting pediatric trials prior to marketing approval.
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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
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Original Message:
Sent: 04-Nov-2019 14:59
From: David Lucking
Subject: Pediatric Studies
Dear Colleagues,
Can a Sponsor conduct a Phase 1/2a clinical study for a topical drug at 3% in children (2+ years old) if there is clinical data in adults at 1%? Can the pediatric study be done in parallel with the adult study or would results at 3% in adults be necessary first?
Thank you.
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David Lucking
FL
United States
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