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

What is crucial when assessing drug efficacy in pediatric studies?

1. Sample size calculation

2. Social media impact

3. Randomization techniques

4. Minimizing healthcare costs

The correct answer is: Sample size calculation

When assessing drug efficacy in pediatric studies, the calculation of sample size is crucial because it directly impacts the reliability and validity of the study's results. A well-calculated sample size ensures that the study has enough statistical power to detect a real effect if one exists, which is particularly important when working with pediatric populations that may have unique responses to medications compared to adults. In pediatric research, recruitment can be challenging due to ethical considerations and the need for parental consent, so careful sample size calculations help in planning and justifying the study design. Without an adequate sample size, the study may either fail to show a drug's efficacy due to insufficient data or expose children to unnecessary risks if the study is unreasonably large and prolonged. While other considerations such as randomization techniques can improve the robustness of a study, and the impact of social media and minimizing healthcare costs are relevant in broader contexts, they do not take precedence over the fundamental need for a properly calculated sample size in ensuring the effectiveness and safety of drug evaluations in the pediatric population.