Abstract
Despite an increasing incidence and prevalence of pediatric inflammatory bowel disease (pIBD),1 relatively few randomized controlled trials (RCTs) are performed in children compared with adults. pIBD trials typically occur several years after adult regulatory approval, leading to “off-label” medication use without knowledge of optimal dosing. In addition, the scope of the clinical development pathways in pediatric populations differs from adults. Typically, a dedicated pediatric dose-ranging study is required to determine pharmacokinetics and pharmacodynamics, safety, and tolerability, before a pediatric efficacy trial, which may or may not include placebo.
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