Challenges in IBD Research: Pragmatic Clinical Research

Frank I Scott¹, David T Rubin², Subra Kugathasan³, Athos Bousvaros⁴, Charles O Elson⁵, Rodney D Newberry⁶, Gil Y Melmed⁷, Joel Pekow⁸, James W Fleshman⁹, Brendan M Boyle¹⁰, Uma Mahadevan¹¹, Lisa Marie Cannon¹², Millie D Long¹³, Raymond K Cross¹⁴, Christina Y Ha⁷, Karen L Lasch¹⁵, Anne M Robinson¹⁶, Janice F Rafferty¹⁷, Jessica J Lee¹⁸, Karen D Cowden Dahl¹⁹, Alandra Weaver²⁰, Nataly Shtraizent²⁰, Gerard Honig²⁰, Andrés Hurtado-Lorenzo²⁰, Caren A Heller²⁰

Affiliations

¹ Division of Gastroenterology and Hepatology, University of Colorado School of Medicine, Aurora, CO, USA.
² University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL, USA.
³ Division of Pediatric Gastroenterology, Department of Pediatrics, Emory University School of Medicine & Children's Healthcare of Atlanta, Atlanta, GA, USA.
⁴ Division of Gastroenterology and Nutrition, Children's Hospital Boston, Boston, MA, USA.
⁵ Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
⁶ Department of Internal Medicine, Washington University School of Medicine, St. Louis, MO, USA.
⁷ Inflammatory Bowel Disease Center, Cedars-Sinai Medical Center, Los Angeles, Los Angeles, CA, USA.
⁸ University of Chicago, Chicago, IL, USA.
⁹ Department of Surgery Baylor University Medical Center, Dallas, TX, USA.
¹⁰ Nationwide Childrens Hospital, Washington, DC, USA.
¹¹ University of California San Francisco, San Francisco, CA, USA.
¹² University of Chicago Medicine, Chicago, IL, USA.
¹³ Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
¹⁴ University of Maryland School of Medicine, Baltimore, MD, USA.
¹⁵ Takeda Pharmaceuticals, Chicago, IL, USA.
¹⁶ AbbVie, Chicago, IL, USA.
¹⁷ Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
¹⁸ U.S. Food and Drug Administration, Silver Spring, MD, USA.
¹⁹ Indiana University School of Medicine, South Bend, IN, USA.
²⁰ Crohn's & Colitis Foundation, New York, NY, USA.

PMID: 31095704
DOI: 10.1093/ibd/izz085

Challenges in IBD Research: Pragmatic Clinical Research

Frank I Scott et al. Inflamm Bowel Dis. 2019.

. 2019 May 16;25(Suppl 2):S40-S47.

doi: 10.1093/ibd/izz085.

Authors

Affiliations

¹ Division of Gastroenterology and Hepatology, University of Colorado School of Medicine, Aurora, CO, USA.
² University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL, USA.
³ Division of Pediatric Gastroenterology, Department of Pediatrics, Emory University School of Medicine & Children's Healthcare of Atlanta, Atlanta, GA, USA.
⁴ Division of Gastroenterology and Nutrition, Children's Hospital Boston, Boston, MA, USA.
⁵ Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
⁶ Department of Internal Medicine, Washington University School of Medicine, St. Louis, MO, USA.
⁷ Inflammatory Bowel Disease Center, Cedars-Sinai Medical Center, Los Angeles, Los Angeles, CA, USA.
⁸ University of Chicago, Chicago, IL, USA.
⁹ Department of Surgery Baylor University Medical Center, Dallas, TX, USA.
¹⁰ Nationwide Childrens Hospital, Washington, DC, USA.
¹¹ University of California San Francisco, San Francisco, CA, USA.
¹² University of Chicago Medicine, Chicago, IL, USA.
¹³ Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
¹⁴ University of Maryland School of Medicine, Baltimore, MD, USA.
¹⁵ Takeda Pharmaceuticals, Chicago, IL, USA.
¹⁶ AbbVie, Chicago, IL, USA.
¹⁷ Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
¹⁸ U.S. Food and Drug Administration, Silver Spring, MD, USA.
¹⁹ Indiana University School of Medicine, South Bend, IN, USA.
²⁰ Crohn's & Colitis Foundation, New York, NY, USA.

PMID: 31095704
DOI: 10.1093/ibd/izz085

Abstract

Pragmatic clinical research is part of five focus areas of the Challenges in IBD research document, which also includes preclinical human IBD mechanisms, environmental triggers, novel technologies, and precision medicine. The Challenges in IBD research document provides a comprehensive overview of current gaps in inflammatory bowel diseases (IBD) research and delivers actionable approaches to address them. It is the result of multidisciplinary input from scientists, clinicians, patients, and funders, and represents a valuable resource for patient centric research prioritization. In particular, the pragmatic clinical research section is focused on highlighting gaps that need to be addressed in order to optimize and standardize IBD care. Identified gaps include: 1) understanding the incidence and prevalence of IBD; 2) evaluating medication positioning to increase therapeutic effectiveness; 3) understanding the utility of therapeutic drug monitoring (TDM); 4) studying pain management; and 5) understanding healthcare economics and resources utilization. To address these gaps, there is a need to emphasize the use of emerging data sources and real-world evidence to better understand epidemiologic and therapeutic trends in IBD, expanding on existing data to better understand how and where we should improve care. Proposed approaches include epidemiological studies in ethnically and geographically diverse cohorts to estimate incidence and prevalence of IBD and impact of diversity on treatment patterns and outcomes. The implementation of new clinical trial design and methodologies will be essential to evaluate optimal medication positioning, appropriate use of TDM in adults and children, and multidisciplinary approaches to IBD pain management and its impact on healthcare resources.

Keywords: Crohn’s disease; claims data; clustered randomization; epidemiology; observational studies; pragmatic clinical research; randomized controlled trial; real-world evidence; registries; ulcerative colitis.

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Challenges in IBD Research: Pragmatic Clinical Research

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Challenges in IBD Research: Pragmatic Clinical Research

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