1. Ethical Concerns: Conducting clinical trials in children raises ethical issues, particularly around informed consent and the potential risks versus benefits. 2. Recruitment and Participation: Enrolling pediatric patients in clinical trials can be difficult due to parental concerns, the need for specialized pediatric research centers, and the smaller pool of eligible participants. 3. Age-Appropriate Formulations: Developing drug formulations that are suitable for children of different ages, from neonates to adolescents, adds complexity to the research process.