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

Which factor does NOT influence the timing of pediatric studies in clinical development?

1. Medicinal product

2. Type of disease being treated

3. Size of the subject population

4. Efficacy and safety of alternative treatments

The correct answer is: Size of the subject population

The correct choice highlights that the size of the subject population does not directly influence the timing of pediatric studies in clinical development. Timing is generally more affected by factors such as the medicinal product being tested, the type of disease being treated, and the availability of alternative treatments that can provide context to the urgency of developing a new treatment. For instance, the characteristics of the medicinal product and its anticipated interaction with pediatric physiology can significantly dictate when the studies should begin. The type of disease being treated is also critical; certain conditions may necessitate earlier pediatric evaluation due to their prevalence or severity in children. Furthermore, if there are already effective treatments available, this could affect the timing due to considerations surrounding the necessity for a new intervention. While the size of the subject population is important for statistical power and the generalizability of findings, it does not inherently dictate when to commence pediatric studies. Instead, it may guide considerations for recruitment efforts and logistics once the timing has been established based on the other influencing factors.