Abstract Background Data regarding the experience and unmet needs of individuals enrolled to IBD clinical trials are limited, and challenges to participation are underexplored. To address this knowledge gap, a non-interventional study was conducted utilising qualitative interviews of individuals who participated or declined to participate in a phase 2/3 clinical trial of moderate-to-severe ulcerative colitis (UC) or Crohn’s disease (CD). Methods Semi-structured, 30- to 60- minute telephone interviews were conducted with individuals who were screened for or took part in a clinical trial up to two years prior. The primary objective was to capture the clinical trial experience of people living with IBD, identifying unmet needs and key challenges that impact trial participation. Topics covered motivations, expectations and experiences related to trial participation. Reasons for declining were discussed with those who did not participate in a clinical trial. Results From May to October 2023, 35 individuals were enrolled (n = 30 Poland; n = 4 Germany; n = 1 USA); 27 had completed a clinical trial, two had withdrawn and six declined to participate. Mean age was 37 years and 71% were female. The main concern prior to trial enrolment was potential side effects, as cited by 45% of trial participants and all those who declined to participate. Other concerns were potential lack of drug efficacy, time commitment, and the possibility of receiving placebo (Table). In total, 58% of trial participants identified restrictions around pregnancy as a potential barrier to participation; the most commonly perceived (≥15%) barriers to participation were side effects, travel considerations, frequency of assessments and study procedures. The most cited reasons for declining trial participation were side effects, opinions of family and/or friends, and time commitment (Table). Common suggestions (≥15%) from participants to improve trial experience included reducing study visit length, providing access to study results and permitting self-administration of medication at home. Further suggestions for improvement are described in the Table. Conclusion Our findings highlight the importance of early communication between clinicians, trial participants and their families regarding concerns such as potential side effects and restrictions around pregnancy. More convenient study visits and improving access to open-label extension programmes could make IBD trials more participant-inclusive, reduce trial burden and improve recruitment and retention. The results of this study have informed the trial design for four ongoing phase 3 clinical trials of afimkibart for people with UC (AMETRINE-1 NCT06589986, AMETRINE-2 NCT06588855) and CD (SIBERITE-1 NCT06819878 and SIBERITE-2 NCT06819891). Conflict of interest: Saldaña, Roberto: Logistic expenses coverage to attend scientific congresses from AbbVie. Atreya, Raja: Honoraria from AbbVie, Abivax, AlfaSigma, AstraZeneca, Boehringer, Bristol Myers Squibb, Celltrion Healthcare, Galapagos, InDex Pharmaceuticals, Johnson & Johnson, Lilly, MSD, Pfizer and Takeda consulting or advisory role/board from AbbVie, Abivax, AstraZeneca, Boehringer, Bristol Myers Squibb, Celltrion Healthcare, Galapagos, Johnson & Johnson, Lilly, MSD, Pfizer, F. Hoffmann-La Roche Ltd and Takeda speakers’ bureau from AbbVie, Abivax, AlfaSigma, AstraZeneca, Bristol Myers Squibb, Celltrion Healthcare, Galapagos, Johnson & Johnson, Lilly, MSD, Pfizer and Takeda research funding from AbbVie, Takeda, InDex Pharmaceuticals. Deepak, Parakkal: Parakkal Deepak has received research support under a sponsored research agreement unrelated to the data in the abstract from AbbVie, Johnson and Johnson, Sanofi, Merck, Teva, Direct Biologics, Tr1x, Boehringer Ingelheim, Bristol Myers Squibb, Pfizer, Prometheus Biosciences, Takeda Pharmaceuticals, Roche Genentech, Eli Lilly, AstraZeneca, Spyre and Agomab, has received consulting fees from Johnson and Johnson, Abbvie, Merck, Sobi, Celltrion, Fresenius Kabi, Asahi Kasei Pharma, Sandoz and CorEvitas, LLC and has served on the board of the Srategic Alliance for Intercultural Advocacy in GI. Low, Jason: Employment at Genentech, Inc. stock or other ownership interests from F. Hoffmann-La Roche Ltd. Mr. Eisner, Tomáš: Employment and stocks from F. Hoffmann-La Roche Ltd. Meyer, Ina: Employment and stock or other ownership interests from F. Hoffmann-La Roche AG. Philpott, Stephanie: Employment from IQVIA and conducted work as an employee of IQVIA for a project funded by F. Hoffmann-La Roche Ltd. Kierkuś, Jarosław: Speakers’ Bureau from Nestle, Ferring and Danone. Grant from Nestle.
Saldaña et al. (Thu,) studied this question.