The Role of Biomarkers in Clinical Trials of Inflammatory Bowel Disease

Inflammatory Bowel Diseases
Reena KhannaBrian G Feagan

Abstract

Clinical trials require valid outcome measures to assess the therapeutic benefit of investigational agents. Recently, regulatory authorities have mandated the use of patient-reported outcomes in combination with an objective measure of disease activity as primary outcome measures in inflammatory bowel disease trials. Endoscopy has commonly fulfilled the latter role; however, due to the costs and complexity of these assessments, interest has emerged in the use of noninvasive biomarkers. The role of C-reactive protein, fecal calprotectin, and fecal lactoferrin in clinical research is discussed.

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Citations

Feb 19, 2019·Gastroenterology Research and Practice·Arash AssadsangabiAlan Lobo
Feb 18, 2020·Frontiers in Medicine·Jack S CornishJan Däbritz
Jan 29, 2019·Frontiers in Pediatrics·Lindsay M MoyeJon Marc Rhoads
Mar 31, 2021·Inflammatory Bowel Diseases·Juan HernandezBlandine Lieubeau

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