A review of activity indices and end points for clinical trials in children with Crohn's disease.
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.
Griffiths
Anne M
AM
Hospital for Sick Children, Toronto, Ontario, Canada. anne.griffiths@sickkids.ca
Otley
Anthony R
AR
Hyams
Jeffrey
J
Quiros
Antonio R
AR
Grand
Richard J
RJ
Bousvaros
Athos
A
Feagan
Brian G
BG
Ferry
George R
GR
D000293:Adolescent; D002648:Child; D002657:Child Development; D002669:Child Welfare; D002986:Clinical Trials as Topic; D003424:Crohn Disease / Q000628:therapy*; D023381:Endpoint Determination; D005260:Female; D005762:Gastroenterology / Q000639:trends; D006801:Humans; D008297:Male; D011788:Quality of Life; D012107:Research Design; D012720:Severity of Illness Index