Patient-Reported Outcomes as Primary End Points in Clinical Trials of Inflammatory Bowel Disease

Volume: 12, Issue: 8, Pages: 1246 - 1256
Published: Aug 1, 2014
Abstract
The Food and Drug Administration (FDA) is moving from the Crohn's Disease Activity Index to patient-reported outcomes (PROs) and objective measures of disease, such as findings from endoscopy. PROs will become an important aspect of assessing activity of inflammatory bowel disease (IBD) and for labeling specific drugs for this disease. PROs always have been considered in the management of patients with rheumatoid arthritis or multiple sclerosis,...
Paper Details
Title
Patient-Reported Outcomes as Primary End Points in Clinical Trials of Inflammatory Bowel Disease
Published Date
Aug 1, 2014
Volume
12
Issue
8
Pages
1246 - 1256
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