FDA qualifies C-Path’s irritable bowel syndrome PRO tool

Written by Ilana Landau, Editor

The Patient-Reported Outcome (PRO) Consortium at the Critical Path Institute (C-Path; AZ, USA) has announced that its ‘Diary for Irritable Bowel Syndrome Symptoms – Constipation’ (DIBSS-C), a PRO tool designed to help facilitate collection of reliable symptom-related information in clinical trials of treatments for constipation-predominant irritable bowel syndrome in adults, has been qualified by the US FDA through its Clinical Outcome Assessment Qualification Program. Irritable bowel syndrome is a chronic, functional disorder affecting the digestive system; there are currently no consistent and reliable biomarkers for the diagnosis of such functional bowel disorders, meaning that diagnosis is based on symptom criteria....

To view this content, please register now for access

It's completely free