title: Ethical considerations for clinical trials in inflammatory bowel disease.
abstract: Although advancements in the field of inflammatory bowel disease (IBD) include effective therapies for many patients with Crohn's disease and ulcerative colitis, there remains a large unmet need, and there is a large number of investigational agents in the pipeline. Drug development through clinical trials is critical to understanding the safety and efficacy of new therapies in the affected human population, and the need for ethical trial design is of the utmost importance. This paper explores the ethical issues of clinical trials in IBD, focusing on placebo-controlled trials, vulnerable patients, exposure to monoclonal antibodies, globalization of trials, and surgical advances.
authors.affiliation: Dr Rubin is a professor of medicine, codirector of the Inflammatory Bowel Disease Center, and associate section chief for educational programs at the University of Chicago Medicine in Chicago, Illinois. Mr Becker is a student at the University of Chicago, where he is also a microbiology research specialist for the Schneewind/Missiakas Lab. Dr Siegler is the Lindy Bergman Distinguished Service Professor of Medicine and Surgery at the University of Chicago Medicine, founding director of the University of Chicago's MacLean Center for Clinical Medical Ethics, and executive director of its Bucksbaum Institute for Clinical Excellence.
authors.forename: David T
authors.initials: DT
authors.lastname: Rubin
authors.affiliation: Dr Rubin is a professor of medicine, codirector of the Inflammatory Bowel Disease Center, and associate section chief for educational programs at the University of Chicago Medicine in Chicago, Illinois. Mr Becker is a student at the University of Chicago, where he is also a microbiology research specialist for the Schneewind/Missiakas Lab. Dr Siegler is the Lindy Bergman Distinguished Service Professor of Medicine and Surgery at the University of Chicago Medicine, founding director of the University of Chicago's MacLean Center for Clinical Medical Ethics, and executive director of its Bucksbaum Institute for Clinical Excellence.
authors.forename: Samuel
authors.initials: S
authors.lastname: Becker
authors.affiliation: Dr Rubin is a professor of medicine, codirector of the Inflammatory Bowel Disease Center, and associate section chief for educational programs at the University of Chicago Medicine in Chicago, Illinois. Mr Becker is a student at the University of Chicago, where he is also a microbiology research specialist for the Schneewind/Missiakas Lab. Dr Siegler is the Lindy Bergman Distinguished Service Professor of Medicine and Surgery at the University of Chicago Medicine, founding director of the University of Chicago's MacLean Center for Clinical Medical Ethics, and executive director of its Bucksbaum Institute for Clinical Excellence.
authors.forename: Mark
authors.initials: M
authors.lastname: Siegler
keywords: Inflammatory bowel disease; clinical trials; ethics; surgical interventions