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A review of activity indices and end points for clinical trials in children with Crohn's disease.

Authors
  • Griffiths, Anne M
  • Otley, Anthony R
  • Hyams, Jeffrey
  • Quiros, Antonio R
  • Grand, Richard J
  • Bousvaros, Athos
  • Feagan, Brian G
  • Ferry, George R
Type
Published Article
Journal
Inflammatory bowel diseases
Publication Date
Feb 01, 2005
Volume
11
Issue
2
Pages
185–196
Identifiers
PMID: 15677913
Source
Medline
License
Unknown

Abstract

The necessity to include children and adolescents in clinical trials is increasingly recognized. Two recent workshops provided the impetus for pediatric gastroenterologists to develop evidence-based recommendations concerning end points and outcome assessment in cases of pediatric Crohn's disease. The overall goal was to facilitate clinical trial design by standardizing the methodology. This article critically reviews the available assessment tools and provides consensus recommendations for the evaluation of linear growth, disease activity, and health-related quality of life in clinical trials in pediatric Crohn's disease.

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