Date: 2013-01-25
Reference number: OPUSeJ 201301251219IBD
Links: http://www.sciencedirect.com/science/article/pii/S001650851201387X
Title: Challenges to the Design, Execution, and Analysis of Randomized Controlled Trials for Inflammatory Bowel Disease
Authors: Geert D’Haens 1, Brian Feagan 2, Jean–Frédéric Colombel 3, William J. Sandborn 4, Walter Reinisch 5, Paul Rutgeerts 6, Frank Carbonnel 7, Jean–Yves Mary 8, Silvio Danese 9, Richard N. Fedorak 10, Steven Hanauer 11, Marc Lémann 12.
Abstract: Treatment of inflammatory bowel disease has greatly improved with the development of targeted, monoclonal antibody–based therapies. Tumor necrosis factor antagonists are frequently used to treat patients with Crohn’s disease or ulcerative colitis, but they have side effects and their efficacy often decreases with use. New, more effective drugs are therefore needed and in development. However, many agents that appeared to be promising in preclinical studies have failed to show efficacy in clinical trials. We discuss possible reasons for the failures of these reagents in trials, which include the high rate of response to placebo, an inadequate range of doses, inappropriate timing of end point measurements, the changing therapeutic environment, and the competitive trial system. We also review regulatory guidelines for end points and trial design and recommend ways to improve trials.
Author bio: N/A
Sponsor editor: N/A
Affiliations/disclaimers/funding/acknowledgements:
1 Academic Medical Center, Amsterdam, The Netherlands, and Robarts Europe
2 University of Western Ontario and Robarts Clinical Trials, London, Ontario, Canada
3 CHRU Lille, Lille, France
4 University of California, San Diego, San Diego, California, and Robarts West
5 University of Vienna, Vienna, Austria
6 Catholic University of Leuven, Leuven, Belgium
7 Hôpitaux Universitaires Paris-Sud, Paris, France
8 INSERM Unité 717, University Paris Diderot, France
9 IRCCS Istituto Clinico Humanitas, Milan, Italy
10 University of Alberta, Edmonton, Alberta, Canada
11 University of Chicago, Chicago, Illinois
12 Hôpital Saint Louis, Paris, France
Keywords: Inflammatory Bowel Disease, Crohn’s Disease , Ulcerative Colitis , Trial Design , Clinical Trials
Subject: Medicine/inflammatory bowel disease
Language: English
Bibliography: alphabetical N/A
Citation: D’Haen, G et al, 2012, “Challenges to the Design, Execution and Analysis of Randomized Controlled Trials for Inflammatory Bowel Disease”, Gastroenterology 143:6,1461–1469. http://www.sciencedirect.com/science/article/pii/S001650851201387X
References: see Forum http://www.opusej.org/library/challenges-to-the-design-execution-and-analysis-of-randomized-controlled-trials-for-inflammatory-bowel-disease-forum/