Steps Toward Harmonization for Clinical Development of Medicines in Pediatric Ulcerative Colitis - A Global Scientific Discussion, Part 2: Data Extrapolation, Trial Design, and Pharmacokinetics

Abstract

Consensus on the efficacy endpoints, disease activity indices, and outcome assessments is needed for globalization of pediatric US trials. The development of noninvasive biomarkers as reliable surrogate endpoints needs to be explored further.

Keywords

• Steps
• Toward
• Harmonization
• for
• Clinical
• Development
• Medicines
• Pediatric
• Ulcerative
• Colitis
• Global
• Scientific
• Discussion
• Part
• Data
• Extrapolation
• Trial
• Design
• Pharmacokinetics