Abstract
ABSTRACT Pediatric drug development has many unique challenges, one of which is the evaluation of growth and development changes in children that are expected and are not due to the study intervention. Children grow and mature at different pace. The potential impact of the drug could vary with the developmental age of the participants receiving the treatment. For example, sexual maturation is a critical consideration in children of age 10 and above, but not in younger age groups. How the investigational drug impacts children is ultimately a risk-benefit consideration. In this paper, practical considerations and recommendations are provided on how to assess growth and development based on data collected from clinical trials in pediatric patients. The endpoints and measures related to growth, sexual maturation and neurocognitive development are discussed. Basic analysis approaches are recommended.
Published Version
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