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

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....