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Use of Placebo in Pediatric Inflammatory Bowel Diseases
- Source :
- Journal of Pediatric Gastroenterology and Nutrition, 62(1), 183-187. Lippincott Williams and Wilkins, Journal of Pediatric Gastroenterology and Nutrition, 62(1), 183-187. Lippincott Williams & Wilkins
- Publication Year :
- 2016
- Publisher :
- Lippincott Williams and Wilkins, 2016.
-
Abstract
- Performing well-designed and ethical trials in pediatric inflammatory bowel diseases (IBD) is a priority to support optimal therapy and reduce the unacceptable long lag between adult and pediatric drug approval. Recently, clinical trials in children have been incorporating placebo arms into their protocols under conditions that created controversy. Therefore, 4 organizations (the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition; European Crohn's and Colitis Organization; the Canadian Children IBD Network; and the Global Pediatric IBD Network) jointly provide a statement on the role of placebo in pediatric IBD trials. Consensus was achieved by 94 of 100 (94%) voting committees' members that placebo should only be used if there is genuine equipoise between the active treatment and placebo; for example, this may be considered in trials of drugs with new mechanisms of action without existing adult data, especially when proven effective alternatives do not exist outside the trial. Placebo may also be used in situations where it is an add-on to an effective therapy or to evaluate exit-strategies of maintenance therapy after long-term deep remission. It has been, however, agreed that no child enrolled in a trial should receive a known inferior treatment both within and outside the trial. This also includes withholding therapy in children who show clinical response after a short induction therapy. Given the similarity between pediatric and adult IBD regarding pathophysiology and response to treatments, drugs generally cannot be considered being in genuine equipoise with placebo if it has proven efficacy in adults. Continued collaboration of all stakeholders is needed to facilitate drug development and evaluation in pediatric IBD.
- Subjects :
- Pathology
Placebos
0302 clinical medicine
Maintenance therapy
SEVERE CROHNS-DISEASE
European Medicines Agency
European Society for Pediatric Gastroenterology
EPISODIC TREATMENT
Child
Clinical Trials as Topic
Gastroenterology
European Crohn's and Colitis Organization
Ulcerative colitis
Europe
ULCERATIVE-COLITIS
Research Design
030220 oncology & carcinogenesis
Therapeutic Equipoise
030211 gastroenterology & hepatology
TRIAL
medicine.drug
medicine.medical_specialty
Canada
Consensus
pediatrics
Placebo
gastroenterology
perinatology and child health
03 medical and health sciences
Pediatric Inflammatory Bowel Diseases, Placebo
INFLIXIMAB
medicine
Adalimumab
Humans
Intensive care medicine
Pediatric gastroenterology
METAANALYSIS
and Nutrition
clinical trials
Hepatology
business.industry
Consensus Development Conference
Drugs, Investigational
medicine.disease
Inflammatory Bowel Diseases
CONSENSUS GUIDELINES
US Food and Drug Administration
Infliximab
Clinical trial
Human Experimentation
Pediatric Inflammatory Bowel Disease Network (PIBDnet)
MAINTENANCE
Pediatrics, Perinatology and Child Health
Position paper
MODERATE
business
ADALIMUMAB
Subjects
Details
- Language :
- English
- ISSN :
- 15364801 and 02772116
- Volume :
- 62
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Journal of Pediatric Gastroenterology and Nutrition
- Accession number :
- edsair.doi.dedup.....59958f8a87fe3ca4e043113428413bb8