Design of Clinical Trials in IBD

The concept of conducting a randomized controlled trial (RCT) to determine the efficacy and safety of new treatments has evolved since its conception. Since the first controlled trial of hydrocortisone therapy in ulcerative colitis in 1955, RCTs have become a global standard for approval of new drugs and devices. Using the examples of RCTs conducted in patients with inflammatory bowel disease (IBD), Prof Feagan discussed the methodologies of clinical trial design and implementation. He also outlined the challenges that clinicians and researchers may face when designing RCTs to address specific therapeutic questions.