Pediatric Extrapolation Of Adult Efficacy to Children Is Critical for Efficient and Successful Drug Development

The Institute for Advancement of Clinical Trials in Children (i-ACT) held a single day meeting on November 17, 2021 in the context of a four session conference on pediatric inflammatory bowel disease (IBD) drug development, more broadly focused on challenges and opportunities in trial design in pediatrics. The unmet need of children with IBD necessitates the discussion and consideration of more broad application of a critical global regulatory concept of pediatric extrapolation. Drug development in pediatric IBD, leading to labeling and market authorization, should be based on extrapolation of adult efficacy data with PK exposure matching and similar PD (endoscopic endpoint) findings, as compared to adult exposure and efficacy assessments.

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