Publications
Systematic Review and Meta-analysis: Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis
Citation
Jairath V, Zou G, Parker CE, Macdonald JK, Mosli MH, Khanna R, Shackelton LM, Vandervoort MK, AlAmeel T, Al Beshir M, AlMadi M, Al-Taweel T, Atkinson NS, Biswas S, Chapman TP, Dulai PS, Glaire MA, Hoekman D, Koutsoumpas A, Minas E, Samaan MA, Travis S, D'Haens G, Levesque BG, Sandborn WJ, Feagan BG. Systematic Review and Meta-analysis: Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis. J Crohns Colitis. 2016 May;10(5):607-18. doi: 10.1093/ecco-jcc/jjw004. Epub 2016 Jan 7. PMID: 26746169; PMCID: PMC4957452.
Abstract
Background and aims: Minimisation of the placebo responses in randomised controlled trials [RCTs] is essential for efficient evaluation of new interventions. Placebo rates have been high in ulcerative colitis [UC] clinical trials, and factors influencing this are poorly understood. We quantify placebo response and remission rates in UC RCTs and identify trial design factors influencing them.