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Clinical Trials in IBD: A Pediatric Perspective.

It has become increasingly evident that the selection of medical therapy in children and adolescents with chronic inflammatory bowel disease (IBD) has resulted either from studies conducted in adult patients (1,2) or experiential observations of pediatric gastroenterologists (3-5). As a result, physicians who wish to provide their pediatric patients with “standard of care” medications do so without the benefit of critical evaluation in this age group. The purpose of this discussion is to address the factors that have contributed to this dilemma and to suggest approaches for implementing age-appropriate objective therapeutic recommendations derived from well-designed clinical trials in children.