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Challenges in IBD Research: Pragmatic Clinical Research.

Frank I Scott1, David T Rubin2, Subra Kugathasan3

  • 1Division of Gastroenterology and Hepatology, University of Colorado School of Medicine, Aurora, CO, USA.

Inflammatory Bowel Diseases
|May 17, 2019
PubMed
Summary

This research addresses critical gaps in inflammatory bowel diseases (IBD) research, focusing on pragmatic clinical studies to improve patient care. It emphasizes real-world evidence and diverse cohorts to optimize IBD treatment and management strategies.

Keywords:
Crohn’s diseaseclaims dataclustered randomizationepidemiologyobservational studiespragmatic clinical researchrandomized controlled trialreal-world evidenceregistriesulcerative colitis

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Area of Science:

  • Gastroenterology and Clinical Research
  • Inflammatory Bowel Diseases (IBD) Research

Background:

  • The Challenges in IBD research document identifies key research gaps and proposes actionable strategies.
  • Pragmatic clinical research is a crucial focus area for optimizing and standardizing IBD care.

Purpose of the Study:

  • To highlight critical gaps in pragmatic clinical research for inflammatory bowel diseases (IBD).
  • To propose actionable approaches for addressing these gaps and advancing IBD care.

Main Methods:

  • Leveraging emerging data sources and real-world evidence (RWE) for epidemiologic and therapeutic trend analysis.
  • Conducting epidemiological studies in diverse cohorts to assess IBD incidence, prevalence, and treatment outcomes.
  • Implementing novel clinical trial designs to evaluate medication positioning, therapeutic drug monitoring (TDM), and pain management.

Main Results:

  • Identified key research gaps: IBD incidence/prevalence, medication positioning, TDM utility, pain management, and healthcare economics.
  • Emphasized the need for RWE to understand epidemiologic and therapeutic trends in IBD.
  • Proposed diverse cohort studies and new clinical trial methodologies for improved IBD care.

Conclusions:

  • Addressing identified gaps requires a focus on pragmatic clinical research, RWE, and diverse populations.
  • Standardizing IBD care necessitates understanding incidence, prevalence, optimal treatments, and resource utilization.
  • Multidisciplinary approaches and innovative trial designs are essential for advancing IBD management and patient outcomes.