Clinical Studies

Abstract

Medical and surgical therapy for complicated IBD patients is often unsatisfactory, and the disease burden remains high despite optimal therapy. To optimise medical therapy, clinical research is necessary in order to develop new therapeutic options as well as diagnostic procedures to understand how diseases begin, progress and can be treated. This is where clinical research becomes an essential aspect of IBD care looked at from a wider perspective. It can be performed either by observation or prospective clinical trials. Clinical trials generate data on safety and efficacy of new drugs or procedures. Understanding different trial approaches is important for IBD nurses; many of whom are directly involved in the care of these patients. Any such nurse is the essential link between patients, physicians and sponsor. Clinical knowledge in IBD is critical not only to detect and document adverse events but also to meet the given endpoints of a clinical study. Study knowledge is important to help patients and colleagues navigate increasingly complex study designs which must appropriately address a wide variety of research questions. While clinical knowledge is addressed elsewhere in this manuscript, this chapter will address key designs, trial terminology and the application of:

• The four phases of clinical trials

• Study designs and key aspect of these such as endpoints

• The practicalities of setting up a clinical trial

• Ethical principles practically applied throughout a study, particularly in discussion with participants

• How studies deal with adverse events

• Individual roles in the study team