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

Which of the following is not a required component of pediatric clinical trial study design?

1. Clear endpoints

2. Appropriate comparators

3. Adequate # of subjects

4. Adult participant inclusion

The correct answer is: Adult participant inclusion

In pediatric clinical trial study design, certain components are essential to ensure the study is well-structured, ethical, and scientifically sound. Clear endpoints are critical because they define what the study aims to measure, thus guiding the study's design and analysis. Appropriate comparators are necessary to determine the efficacy or safety of the treatment being studied compared to existing therapies or placebos. Having an adequate number of subjects ensures that the study has enough power to detect meaningful differences and is representative of the pediatric population. Including adult participants is not a required component in pediatric trials since the primary focus is on pediatric populations. While adult data might inform certain aspects of the pediatric population's understanding, it is not a mandatory requirement for the study design aimed specifically at children. The distinct physiological, developmental, and ethical considerations surrounding pediatric patients mean that studies are typically designed around the children who are the intended recipients of the treatments. Thus, adult participant inclusion does not align with the primary objectives and requirements of pediatric clinical trials.