Advancing Equity and Patient Partnership in Clinical Trials for Inflammatory Bowel Disease: A Model for Inclusive Trial Design.

Purpose: Efficacy rates of advanced therapies for inflammatory bowel disease (IBD) may be improved by combination therapy approaches, which are being investigated in two ongoing phase 4 clinical trials. To ensure relevancy to wider patient populations, understanding and mitigating barriers to recruitment and enrollment early in study development are crucial. Here, we describe the findings of a unique approach in IBD research to proactively engage patients in study design and in the development of accessible patient-facing materials. Methods: EXPLORER 2.0 (NCT06045754) and ExiGem (NCT06095128) are phase 4, open-label trials evaluating the efficacy and safety of combination therapy with vedolizumab and either adalimumab or ustekinumab in patients with moderate to severe Crohn's disease (CD), and vedolizumab and tofacitinib in patients with moderate to severe ulcerative colitis (UC). During protocol development, 90-minute interviews were conducted with individuals with CD or UC to gain qualitative insights into patient perceptions on the study design and informed consent forms (ICFs). Interview participants were members of Inspire, a global online health community platform, and not aware of the study sponsor. Results: Overall, participants found the concept of achieving remission with combination therapy appealing, although they expressed concerns about its safety. Other concerns included the stringent eligibility criteria and the number of clinic visits and procedures involved in the trials. Participants were generally positive about the inclusion of patient-reported outcomes. Participants suggested the use of clearer language in patient materials, including ICFs, and the inclusion of a visual dosing timeline to clarify treatment schedules. Using the participants' feedback, the study protocols and ICFs have been amended. Conclusion: These interview findings directly informed patient-centric modifications to trial protocols and patient-facing materials for the EXPLORER 2.0 and ExiGem trials with the essential goal of improving patient diversity and recruitment, which have been suboptimal in IBD research.