What is the focus of the clinical investigation of medicinal products in the pediatric population?

The focus of the clinical investigation of medicinal products in the pediatric population centers on ensuring the safe, efficient, and ethical study of products specifically designed for children. This area of research recognizes the unique physiological and developmental differences between children and adults, which can significantly influence how medications work in younger patients. Therefore, studies must adhere to strict ethical guidelines to protect child participants and ensure that they receive medications that are both safe and effective for their age group.

By prioritizing safety, efficiency, and ethics, this focus also encompasses the necessity of obtaining informed consent from parents or guardians while respecting the patient's assent when appropriate. The aim is to fill knowledge gaps in pediatric medicine, as many medications are often used off-label in children due to lack of tailored research, reinforcing the importance of dedicated clinical trials in this vulnerable population.