pediatric research equity act

What Are the Key Challenges?

Implementing PREA poses several challenges:
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.

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