Pediatric clinical trials typically follow the same phases as adult trials, but with added safety precautions:
- Phase I: Evaluates safety and dosage in a small group of participants. - Phase II: Assesses efficacy and side effects in a larger group. - Phase III: Confirms efficacy, monitors side effects, and compares the treatment to standard or placebo treatments. - Phase IV: Conducted after FDA approval, focusing on long-term safety and effectiveness.
