Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

What might be included in the development plan for pediatric trials?

1. Adult safety data only

2. Only pharmacokinetic studies

3. Experience with use in children

4. Phase IV data exclusively

The correct answer is: Experience with use in children

The correct answer, experience with use in children, is vital in the development plan for pediatric trials. When designing trials for pediatric populations, it is essential to incorporate data and insights gained from previous experiences with the medication in children. This could include information on efficacy, dosing adjustments, safety profiles, and how the drug performs specifically in younger individuals, which often differs from adult responses. Understanding the nuances of pediatric patients ensures that the clinical development process is tailored to their unique physiological and developmental needs, ultimately leading to better-informed decision-making regarding treatment options for children. Considering the other options, adult safety data alone would not be sufficient since the pediatric population may respond differently to medication than adults do. Including only pharmacokinetic studies would fail to provide a comprehensive view of how the medication is utilized and assessed in children, missing vital safety and efficacy analyses. Focusing exclusively on Phase IV data would limit the development plan to post-marketing experiences, which do not provide the necessary foundational research that should occur in earlier-stage trials specifically focused on the pediatric population.