Challenges in IBD Research: Pragmatic Clinical Research

Frank I. Scott, David T. Rubin, Subra Kugathasan, Athos Bousvaros, Charles O. Elson, Rodney D. Newberry, Gil Y. Melmed, Joel Pekow, James W. Fleshman, Brendan M. Boyle, Uma Mahadevan, Lisa Marie Cannon, Millie D. Long, Raymond K. Cross, Christina Y. Ha, Karen L. Lasch, Anne M. Robinson, Janice F. Rafferty, Jessica J. Lee, Karen Cowden DahlAlandra Weaver, Nataly Shtraizent, Gerard Honig, Andrés Hurtado-Lorenzo, Caren A. Heller

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)S40-S47
JournalInflammatory bowel diseases
Volume25
Issue number2
DOIs
StatePublished - May 16 2019

Fingerprint

Inflammatory Bowel Diseases
Research
Drug Monitoring
Pain Management
Delivery of Health Care
Precision Medicine
Information Storage and Retrieval
Incidence
Disease Management
Epidemiologic Studies
Economics
Clinical Trials
Technology
Therapeutics

Keywords

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

ASJC Scopus subject areas

  • Immunology and Allergy
  • Gastroenterology

Cite this

Scott, F. I., Rubin, D. T., Kugathasan, S., Bousvaros, A., Elson, C. O., Newberry, R. D., ... Heller, C. A. (2019). Challenges in IBD Research: Pragmatic Clinical Research. Inflammatory bowel diseases, 25(2), S40-S47. https://doi.org/10.1093/ibd/izz085

Challenges in IBD Research : Pragmatic Clinical Research. / Scott, Frank I.; Rubin, David T.; Kugathasan, Subra; Bousvaros, Athos; Elson, Charles O.; Newberry, Rodney D.; Melmed, Gil Y.; Pekow, Joel; Fleshman, James W.; Boyle, Brendan M.; Mahadevan, Uma; Cannon, Lisa Marie; Long, Millie D.; Cross, Raymond K.; Ha, Christina Y.; Lasch, Karen L.; Robinson, Anne M.; Rafferty, Janice F.; Lee, Jessica J.; Cowden Dahl, Karen; Weaver, Alandra; Shtraizent, Nataly; Honig, Gerard; Hurtado-Lorenzo, Andrés; Heller, Caren A.

In: Inflammatory bowel diseases, Vol. 25, No. 2, 16.05.2019, p. S40-S47.

Research output: Contribution to journalArticle

Scott, FI, Rubin, DT, Kugathasan, S, Bousvaros, A, Elson, CO, Newberry, RD, Melmed, GY, Pekow, J, Fleshman, JW, Boyle, BM, Mahadevan, U, Cannon, LM, Long, MD, Cross, RK, Ha, CY, Lasch, KL, Robinson, AM, Rafferty, JF, Lee, JJ, Cowden Dahl, K, Weaver, A, Shtraizent, N, Honig, G, Hurtado-Lorenzo, A & Heller, CA 2019, 'Challenges in IBD Research: Pragmatic Clinical Research', Inflammatory bowel diseases, vol. 25, no. 2, pp. S40-S47. https://doi.org/10.1093/ibd/izz085
Scott FI, Rubin DT, Kugathasan S, Bousvaros A, Elson CO, Newberry RD et al. Challenges in IBD Research: Pragmatic Clinical Research. Inflammatory bowel diseases. 2019 May 16;25(2):S40-S47. https://doi.org/10.1093/ibd/izz085
Scott, Frank I. ; Rubin, David T. ; Kugathasan, Subra ; Bousvaros, Athos ; Elson, Charles O. ; Newberry, Rodney D. ; Melmed, Gil Y. ; Pekow, Joel ; Fleshman, James W. ; Boyle, Brendan M. ; Mahadevan, Uma ; Cannon, Lisa Marie ; Long, Millie D. ; Cross, Raymond K. ; Ha, Christina Y. ; Lasch, Karen L. ; Robinson, Anne M. ; Rafferty, Janice F. ; Lee, Jessica J. ; Cowden Dahl, Karen ; Weaver, Alandra ; Shtraizent, Nataly ; Honig, Gerard ; Hurtado-Lorenzo, Andrés ; Heller, Caren A. / Challenges in IBD Research : Pragmatic Clinical Research. In: Inflammatory bowel diseases. 2019 ; Vol. 25, No. 2. pp. S40-S47.
@article{2e43cc129dd74131bc6b2dffc99fe5e7,
title = "Challenges in IBD Research: Pragmatic Clinical Research",
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 = "claims data, clustered randomization, Crohn’s disease, epidemiology, observational studies, pragmatic clinical research, randomized controlled trial, real-world evidence, registries, ulcerative colitis",
author = "Scott, {Frank I.} and Rubin, {David T.} and Subra Kugathasan and Athos Bousvaros and Elson, {Charles O.} and Newberry, {Rodney D.} and Melmed, {Gil Y.} and Joel Pekow and Fleshman, {James W.} and Boyle, {Brendan M.} and Uma Mahadevan and Cannon, {Lisa Marie} and Long, {Millie D.} and Cross, {Raymond K.} and Ha, {Christina Y.} and Lasch, {Karen L.} and Robinson, {Anne M.} and Rafferty, {Janice F.} and Lee, {Jessica J.} and {Cowden Dahl}, Karen and Alandra Weaver and Nataly Shtraizent and Gerard Honig and Andr{\'e}s Hurtado-Lorenzo and Heller, {Caren A.}",
year = "2019",
month = "5",
day = "16",
doi = "10.1093/ibd/izz085",
language = "English (US)",
volume = "25",
pages = "S40--S47",
journal = "Inflammatory Bowel Diseases",
issn = "1078-0998",
publisher = "John Wiley and Sons Inc.",
number = "2",

}

TY - JOUR

T1 - Challenges in IBD Research

T2 - Pragmatic Clinical Research

AU - Scott, Frank I.

AU - Rubin, David T.

AU - Kugathasan, Subra

AU - Bousvaros, Athos

AU - Elson, Charles O.

AU - Newberry, Rodney D.

AU - Melmed, Gil Y.

AU - Pekow, Joel

AU - Fleshman, James W.

AU - Boyle, Brendan M.

AU - Mahadevan, Uma

AU - Cannon, Lisa Marie

AU - Long, Millie D.

AU - Cross, Raymond K.

AU - Ha, Christina Y.

AU - Lasch, Karen L.

AU - Robinson, Anne M.

AU - Rafferty, Janice F.

AU - Lee, Jessica J.

AU - Cowden Dahl, Karen

AU - Weaver, Alandra

AU - Shtraizent, Nataly

AU - Honig, Gerard

AU - Hurtado-Lorenzo, Andrés

AU - Heller, Caren A.

PY - 2019/5/16

Y1 - 2019/5/16

N2 - 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.

AB - 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.

KW - claims data

KW - clustered randomization

KW - Crohn’s disease

KW - epidemiology

KW - observational studies

KW - pragmatic clinical research

KW - randomized controlled trial

KW - real-world evidence

KW - registries

KW - ulcerative colitis

UR - http://www.scopus.com/inward/record.url?scp=85066845279&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85066845279&partnerID=8YFLogxK

U2 - 10.1093/ibd/izz085

DO - 10.1093/ibd/izz085

M3 - Article

C2 - 31095704

AN - SCOPUS:85066845279

VL - 25

SP - S40-S47

JO - Inflammatory Bowel Diseases

JF - Inflammatory Bowel Diseases

SN - 1078-0998

IS - 2

ER -