FDA Recommends Primary Endpoints, Assessment Tools for Ulcerative Colitis Therapies

The FDA wants drugmakers to use clinical remission as their primary endpoint when conducting trials for short-term ulcerative colitis therapies.

The agency is relegating other data points in ulcerative colitis cases — such as stool frequency, rectal bleeding and endoscopy subscore — to secondary endpoints in a draft guidance. The document focuses exclusively on efficacy endpoints and suggests both ideal and practical assessment tools.

To evaluate these endpoints, the FDA said patient-reported outcomes, observer-reported outcomes and clinician-reported outcomes represent “the three clinical outcome assessment types relevant to the measurement” of ulcerative colitis signs and symptoms.