Special Challenges in Pediatric Drug Development: First of Three Sets of Expanded Proceedings from the ISCTM Autumn Conference on Pediatric Drug Development.

This paper expands upon a session, entitled, "Special Challenges in Pediatric Drug Development," that was presented as part of a two-day meeting on Pediatric Drug Development at the International Society for Central Nervous System (CNS) Clinical Trials and Methodology (ISCTM) Autumn Conference in Boston, Massachusetts, in October 2020. Drug development in this age group is particularly important because many illnesses have their onset in this age group, many other illnesses that are more common in adults also occur in this time period, and many rare conditions that require special consideration (i.e., orphan conditions) are commonly detected in childhood as well. The special challenges addressed by our speakers in this session were cognitive and functional capacity assessment, challenges of recruitment and assessment of children for research and development of appropriate biomarkers for use in child populations, and the special challenges in training raters to address symptoms in pediatric populations. The speakers have written summaries of their talks. The session's lead chair was Philip D. Harvey, PhD, who wrote introductory and closing comments. This paper should serve as an expert-informed reference to those interested in and involved in addressing the special challenges facing those involved in CNS pediatric drug development.