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.