Celiac.com 10/14/2015 - For the past few years, the FDA has held an annual public workshop to discuss the selection of end points and clinical outcome measures appropriate for drug development in GI diseases.

FDA logo. Image: Wikimedia Commons.This spring, for the first time, celiac disease made it onto the agenda of the Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT 3) meeting. At the meeting, experts discussed the challenges of identifying an appropriate target population for pharmacologic therapy, defining and measuring efficacy in clinical trials for celiac disease, and the timing of assessment end points.

GREAT 3 was held March 30 to 31, 2015, and was cosponsored by the American College of Gastroenterology; American Gastroenterological Association; Crohn's & Colitis Foundation of America; North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition; Pediatric IBD Foundation; and North American Society for the Study of Celiac Disease.

Among the topics covered at the first GREAT devoted to celiac disease and related issues, were discussions of the appropriate target population for pharmacological therapy in celiac disease, and the definition and measurement of efficacy in celiac disease clinical trials intended to support marketing approval, including the role and timing of assessment of specific endpoints.

There was also much discussion of the need for pharmacologic treatments to accelerate healing in patients with untreated celiac disease and reduce the risks for long-term consequences of ongoing inflammation, even when inflammation is symptomatic.

Read More at GREAT3.org.

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