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Pediatric patients should have access to medicines that have beenappropriately evaluated for safety and efficacy. Given this goal of revisedlabelling, the adequacy of the pediatric clinical development plan andresulting safety database must inform a favorable benefit-risk assessment forthe intended use of the medicinal product. While extrapolation from adults canbe used to support efficacy of drugs in children, there may be a reluctance touse the same approach in safety assessments, wiping out potential gains intrial efficiency through a reduction of sample size. To address thisreluctance, we explore safety review in pediatric trials, including factorsaffecting these data, specific types of safety assessments, and precision onthe estimation of event rates for specific adverse events (AEs) that can beachieved. In addition, we discuss the assessments which can provide a benchmarkfor the use of extrapolation of safety that focuses on on-target effects.Finally, we explore a unified approach for understanding precision usingBayesian approaches as the most appropriate methodology to describe/ascertainrisk in probabilistic terms for the estimate of the event rate of specific AEs.

Extent of Safety Database in Pediatric Drug Development: Types of  Assessment, Analytical Precision, and Pathway for Extrapolation through  On-Target Effects