Pragmatic Clinical Research
Pragmatic clinical research is part of the five focus areas, including preclinical human IBD mechanisms, environmental triggers, novel technologies, and precision medicine, described in the Challenges in IBD Research document.
Pragmatic clinical research should be focused on the implementation of new clinical research methods that use real-world patient populations and observations, to deliver actionable results applicable to clinical practice and aligned with patient care. In other words, the main goal of pragmatic clinical research is to generate data that is relevant for making decisions in real-world clinical settings in order to deliver standardized optimal IBD care.
Specifically, future studies should address the main research gaps in the following areas: 1) understanding the epidemiology of IBD, 2) accurate medication selection to increase treatment effectiveness 3) defining how clinicians are utilizing therapeutic drug monitoring, 4) study of pain management, and 5) understanding the health economics and healthcare resources utilization.
Read more about pragmatic clinical research in in Inflammatory Bowel Diseases.
Currently, The Foundation supports pragmatic clinical research through three initiatives, described below.
A collaboration of major medical centers and smaller practices working on clinical studies focused on standardization and optimization of management and treatment of IBD.
A patient-powered research network that connects patients and researchers, and allows IBD patients to ask questions, propose research ideas, and share their experiences.
Study designed to evaluate the impact of Diversity within the INcidence, Prevalence, Treatment, and OUTcomes in Patients with IBD. INPUT is a multi-institutional 5-year CDC-funded study that will use an innovative strategy to estimate IBD prevalence and incidence in the U.S including non-white minority populations.
The INPUT cohort will be created using the patient recruitment infrastructure from the Foundation’s IBD PLEXUS for adults and the Improve Care Now (ICN) registry for children.
The INPUT study will:
- Build an ethnically diverse registry of patients with diagnosis of Crohn’s disease and ulcerative colitis
- Determine whether race and IBD practice volume are associated with different patterns of care, including delayed diagnosis and adequate treatment in minority groups
- Estimate the incidence and prevalence of IBD at a national level using representative claims data that encompasses populations from all segments of the socioeconomic and geographic distribution of the U.S.