# IBS Trial Guidance Focuses on Endpoints and Design - FDA



## Jeffrey Roberts (Apr 15, 1987)

http://www.fdanews.com/ext/files/IBS.pdf*Guidance for Industry*Irritable Bowel Syndrome - Clinical Evaluation of Products for TreatmentDraft GuidanceThis guidance document is being distributed for comment purposes only.Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document contact Ruyi He at 301-796-0910 or Ann Marie Trentacosti at 770-716-9984. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) March 2010 Clinical/Medical This guidance is intended to assist the pharmaceutical industry and other investigators who are 21 conducting new product development for the treatment of irritable bowel syndrome (IBS). IBS 22 diagnosis and status depends mainly on an assessment of IBS signs and symptoms. However, 23 capturing all of the clinically important signs and symptoms associated with IBS for measuring 24 treatment benefit in clinical trials can be challenging. This guidance addresses three main topics 25 regarding IBS sign and symptom assessment: (1) the evolution of primary endpoints for IBS 26 clinical trials; (2) interim recommendations for IBS clinical trial design and endpoints; and (3) 27 the future development of patient-reported outcome (PRO) instruments for use in IBS clinical 28 trials. These interim recommendations are provided in this guidance until properly developed 29 and validated PRO instruments become available for incorporation in clinical trials. 30 31 This guidance applies to the IBS indications for IBS with diarrhea (IBS-D) and IBS with 32 constipation (IBS-C). Sponsors should contact the Division of Gastroenterology Products for 33 recommendations regarding trial design for other types of IBS populations not discussed in this 34 guidance (i.e., mixed irritable bowel syndrome, unsubtyped irritable bowel syndrome, and 35 alternating irritable bowel syndrome).


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