> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Draft Guidance on Ulcerative Colitis Trial Endpoints
- URL: https://www.fdaweb.com/fda-draft-guidance-on-ulcerative-colitis-trial-endpoints/
- Published: 2016-08-08T12:00:00.000Z
- Updated: 2026-09-14T21:22:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136430

FDA has published a [draft guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM515143.pdf?ref=fdaweb.com) on “Ulcerative Colitis: Clinical Trial Endpoints” that is intended to assist sponsors in their clinical development of drugs for treating the condition in adult and pediatric patients. The document addresses FDA’s current thinking on efficacy endpoints for ulcerative colitis clinical trials. “This draft guidance is intended to serve as a focus for continued discussions among the Division of Gastroenterology and Inborn Errors Products (DGIEP), pharmaceutical sponsors, the academic community, and the public,” the agency says. It does not address the treatment or prevention of long-term complications associated with ulcerative colitis; for example, the guidance is not intended to discuss endpoints for prevention or reduction in colorectal cancer risks. It also does not contain discussions on general issues of statistical analysis or clinical trial design, it says. Those topics are addressed in *ICH guidances on E9 Statistical Principles for Clinical Trials* and *E10 Choice of Control Group and Related Issues in Clinical Trials*.