Thank you to Johnson & Johnson for the support of this FAQ Video Module.

In this FAQ video module, Tedra Gray, a gastroenterology nurse practitioner at Sinai Chicago, breaks down the key differences between treat-through and randomized withdrawal clinical trial designs in inflammatory bowel disease (IBD). This educational overview explains how these two study designs impact the evaluation of new IBD therapies, including their role in assessing safety, efficacy, and long-term patient outcomes. Viewers will learn how treat-through trials randomize patients at baseline to receive either active treatment or placebo throughout the study, offering insights into real-world effectiveness from induction through maintenance. In contrast, randomized withdrawal designs focus on patients who initially respond to therapy, re-randomizing them to continue treatment or switch to placebo—allowing for more efficient study design, reduced placebo exposure, and a focus on maintenance of response.

This video also explores key considerations such as population selection, ethical implications, study objectives, and how these designs are applied in major Phase 3 IBD trials like ASTRO, GRAVITI, GALAXY, and QUASAR. Ideal for gastroenterology providers and advanced practice providers, this content provides practical insights into interpreting clinical trial data and optimizing treatment strategies in IBD.

For more expert-driven GI education, visit the GHAPP Digital Hub and GHAPP ACE app.