Patient and Public Involvement in Research: Lessons for Inflammatory Bowel Disease

Abstract

Participatory research, also referred to as patient and public involvement, is an approach that involves collaborating with patients affected by the focus of the research, on the design, development, and delivery of research to improve outcomes. There are two broad justifications for this; firstly, that it enhances the quality and relevance of research, and secondly, that it satisfies the ethical argument of patient inclusion for decisions about them. This synergistic and collaborative effort, which bridges the divide between researchers and participants with the lived condition, is now a mainstream activity and widely accepted as best practice. Although there has been a substantial increase in the literature over the past two decades, little has been published on how participatory research has been used in inflammatory bowel disease research and little guidance as to how researchers should go about this. With an increasing incidence and prevalence worldwide, combined with declining study enrolment in an era of perennial unmet need, there are a multitude of benefits of participatory research to IBD patients and investigators, including research output that is informed and relevant to the real world. A key example of participatory research in IBD is the I-CARE study, a large-scale, pan-European observational study assessing the safety of advanced therapies, which had significant patient involvement throughout the study. In this review, we provide a comprehensive overview of the benefits and challenges of participatory research and discuss opportunities of building strategic alliances between IBD patients, healthcare providers, and academics to strengthen research outcomes.

Review article: Externally derived control arms—An opportunity for clinical trials in inflammatory bowel disease?

“…2,3 It is widely accepted that a patient-centric approach should be adopted when designing, developing and delivering IBD research studies to improve outcomes. 2,5 A successful randomised controlled trial (RCT), which remains the gold standard for drug development, recruits and retains large numbers of patients to ensure it is adequately powered to draw robust conclusions to facilitate marketing authorisation applications. Regulatory guidance from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) insists on the inclusion of a placebo arm in pivotal trials, where ethical and feasible.…”