eCOA Best Practices For Crohn's And UC Trials

By Branden Kusanto, Greta Marie van Schoor, & Elias Ketiar

Crohn’s Disease (CD) and Ulcerative Colitis (UC) are chronic inflammatory bowel diseases that significantly impact patients worldwide. With approximately 200 clinical trials initiated annually since 2017, the pursuit of effective treatments for these conditions remains a critical focus. Clinical trials rely on composite scoring systems like the Crohn’s Disease Activity Index (CDAI) and Modified Mayo Score (MMS) to assess treatment success, with clinical remission as a primary endpoint.

Integrating these scoring systems into electronic clinical outcome assessment (eCOA) platforms requires careful planning. For CDAI in CD, key considerations include enabling accurate symptom tracking via electronic diaries (eDiaries), incorporating tools like the Bristol Stool Chart, and deciding on hematocrit data input from central labs. MMS for UC requires capturing patients’ baseline stool frequency to automate subscore calculations, addressing challenges in recall accuracy. Both CD and UC trials must navigate FDA recommendations, such as ensuring sufficient eDiary data for subscore calculations and excluding bowel preparation and endoscopy days from analysis. Signant Health’s expertise in eCOA systems for CD and UC trials ensures reliable solutions tailored to the unique complexities of these studies, fostering accurate data collection and trial success.