Past Trials Can Provide Score For Temporary Ulcerative Colitis Endpoint, FDA Told
This article was originally published in Pharmaceutical Approvals Monthly
Changes in how efficacy of ulcerative colitis drugs are measured are coming, but FDA GREAT2 workshop focused on criteria to use in the interim. An academic/industry consortium plans to submit proposed patient-reported outcome questionnaires for UC and Crohn’s disease to the agency Dec. 20.
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Agency favors assessments of signs/symptoms and endoscopy findings using well-defined and reliable patient- and clinician-reported outcomes instruments; since these don't exist, FDA will allow tweaking of existing assessment tools in the interim.
Panelists at an agency workshop discussed tweaks to the Mayo Clinic Score while patient-reported outcome instruments are being developed in an initiative to create an improved ulcerative colitis endpoint.
At least portions of patient-reported outcome instruments for ulcerative colitis and Crohn’s disease could be ready for use by the end of 2013.