Background: Celiac disease (CeD) affects ~1% of the global population and requires lifelong adherence to a gluten-free diet, yet many patients experience persistent symptoms and intestinal damage. The number of investigational agents targeting CeD has grown; however, clinical trial execution remains challenging. Strict dietary management may motivate reluctance to undergo gluten challenges, while variable provider awareness and site infrastructure may limit enrollment. Given repeated use of the Celiac Disease Foundation’s (CDF) iQualifyCeliac™ platform across several CeD trials, we assessed enrollment impact and site-level experiences. The study aimed to characterize barriers and strategies influencing recruitment and retention at U.S. CeD trial sites.
Methods: Semi-structured interviews were conducted with principal investigators (PIs) (n=10) and site coordinators (SCs) (n=10) from U.S. research sites with CeD trial and iQualifyCeliac™ experience. Quantitative and qualitative content analysis identified experiences related to recruitment strategies, participant engagement, and trial execution, informing development of a best-practices toolkit.
Results: Across diverse sites, the gluten challenge was the most frequently reported recruitment barrier, followed by restrictive eligibility criteria, logistical burdens, and delays obtaining outside records. PIs noted that added time with patients, CDF referrals, local business outreach, educational events, and word-of-mouth led to recruitment success. SCs emphasized that rapid (≤24–48 hours) and persistent (≥4 attempts) outreach improved referral conversion. Communication preferences differed by age group. Retention challenges were infrequent. Both PIs and SCs rated CDF referrals as highly valuable, citing greater awareness, increased trust, higher enrollment yield, and stronger completion rates. All 10 PIs indicated they would recommend CDF recruitment.
Conclusion: Targeted operational strategies, including rapid and diversified outreach, proactive expectation-setting, and collaboration with patient advocacy organizations enhance CeD trial recruitment and retention. The toolkit derived from these findings offers recommendations to accelerate therapeutic development in CeD. Future work should incorporate patient perspectives to refine recruitment and retention strategies.