Inflammatory bowel disease, including Crohn’s disease and ulcerative colitis, is one of the five most prevalent gastrointestinal disorders in the United States, affecting as many as 1.4 million patients. While some effective treatments are currently available, many patients don’t respond to these therapies, and researchers continue to work toward new, better treatments for Crohn’s and UC. This type of research requires clinical trials on human subjects, which raises a number of ethical issues for how the trials are designed and which patients are included.
In a recent review article for the journal Gastroenterology & Hepatology, David Rubin, MD, Section Chief of Gastroenterology, Hepatology and Nutrition at the University of Chicago Medicine, and Mark Siegler, MD, Director of the MacLean Center for Clinical Medical Ethics, looked at the ethical issues involved in designing clinical trials with patients suffering from IBD, specifically:
- When the use of placebos is appropriate
- Consideration of the vulnerability of patients who may be uninsured or lack access to any other means of treatment outside the research setting
- The exposure of subjects to treatments that could trigger an immune response that makes the treatment ineffective once it is finally approved
- Appropriate study recruitment and compensation in developing countries
- Standardization of experimental surgical techniques
“Although there is a clear need for additional therapies that offer more successful disease control and modification of outcomes,” the authors write, “such therapies must be developed through ethically sound clinical trials with appropriate involvement of the global patient population.”