The Role of Biomarkers in Clinical Trials of Inflammatory Bowel Disease

Inflamm Bowel Dis. 2018 Jul 12;24(8):1619-1623. doi: 10.1093/ibd/izy195.

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.

Publication types

  • Editorial

MeSH terms

  • Algorithms
  • Biomarkers / analysis*
  • C-Reactive Protein / analysis
  • Feces / chemistry*
  • Humans
  • Inflammatory Bowel Diseases / blood
  • Inflammatory Bowel Diseases / diagnosis*
  • Lactoferrin / analysis
  • Leukocyte L1 Antigen Complex / analysis
  • Randomized Controlled Trials as Topic

Substances

  • Biomarkers
  • Leukocyte L1 Antigen Complex
  • C-Reactive Protein
  • Lactoferrin