The State of Clinical Trials in Pediatric Inflammatory Bowel Disease

Jeffrey S Hyams; Richard K Russell

doi:10.1016/j.gtc.2023.05.008

The State of Clinical Trials in Pediatric Inflammatory Bowel Disease

Gastroenterol Clin North Am. 2023 Sep;52(3):589-597. doi: 10.1016/j.gtc.2023.05.008. Epub 2023 Jun 20.

Authors

Jeffrey S Hyams¹, Richard K Russell²

Affiliations

¹ Division of Digestive Diseases, Hepatology, and Nutrition, Connecticut Children's Medical Center, 282 Washington Street, Hartford, CT 06106, USA; University of Connecticut School of Medicine, Farmington, CT, USA. Electronic address: jhyams@connecticutchildrens.org.
² Department of Paediatric Gastroenterology, Royal Hospital for Children and Young People, Clinical Staff Offices, 2nd Floor, 50 Little France Crescent, Edinburgh EH16 4TJ.

PMID: 37543402
DOI: 10.1016/j.gtc.2023.05.008

Abstract

The gap between available biologic and small molecule therapy for inflammatory bowel disease for children and adults remains large. At present only 2 anti-TNF agents are licensed for pediatric use compared with multiple other agents with different mechanisms of action being used in adults. The reasons are many but largely revolve around the inadequate acceptance of adult efficacy data to children, and the reluctance of industry to commit to early pediatric drug development for fear of inadequate return on investment. We suggest common sense steps that need to be taken to improve this situation.

Keywords: Children; Clinical trials; Crohn disease; Inflammatory bowel disease; Ulcerative colitis.

Publication types

Review

MeSH terms

Adult
Child
Colitis, Ulcerative* / drug therapy
Crohn Disease* / drug therapy
Humans
Inflammatory Bowel Diseases* / drug therapy
Tumor Necrosis Factor Inhibitors / therapeutic use

Substances

Tumor Necrosis Factor Inhibitors