Introduction
The success of clinical trials in coeliac disease (CeD) depends on adequate recruitment and retention, which may be affected by factors such as gluten challenge, monitoring procedures, repeated visits, placebo use and travel requirements. This study examined motivators, barriers, trial design preferences and willingness to participate in CeD research.
Methods
Adults with medically diagnosed CeD completed an online REDCap survey assessing demographics, clinical history, symptom burden, research experience, participation motivators and barriers, and willingness to undertake study procedures. A hypothetical industry-sponsored trial was included. The survey was distributed via social media and email databases, predominantly in Australia. Descriptive analyses summarised participant characteristics, barriers and preferences.
Results
A total of 473 adults with diagnosed CeD completed the survey (mean age 50 years, 84% female, median time since diagnosis 14 years; 62% had previously participated in CeD research). Motivation was high and driven mainly by altruism, trust and information-seeking. Contributing to research, helping others with CeD and receiving study results were important motivators for 92%, 92% and 93%, respectively, compared with financial compensation for 44%. Confidence-building factors included explanation of the science or drug being tested (90%) and participation through a respected institution (85%). Standard trial procedures were generally acceptable, with avoidance of blood, stool and urine sampling, questionnaires and phone follow-up important to only 10-16% of participants, while avoiding gastroscopy was important to 26%. Most participants would accept 1-10 clinic visits (81%) and 1-10 blood draws (70%) over six months. Gluten challenge concern increased from 43% for a single 8g dose to 69% for six weeks’ exposure.
Conclusion
Adults with CeD are highly motivated to participate when studies are meaningful, clearly explained and delivered through trusted pathways. Future trials should prioritise transparent rationale, return of results, reduced visit burden, flexible scheduling and minimised gluten exposure where possible.