Phase 2 · Celiac disease
WCR enrolled and randomized 8 participants against an original forecast of 6. All 8 completed the full Phase 2 trial, including diary requirements, a gluten challenge, and in-person visits.
Explore the study storyStudy outcome
100%study completion among all 8 randomized participantsInside the case
This Phase 2 celiac disease trial required diary completion, a gluten challenge, and in-person visits. Our team recognized that successful participation depended on a clear understanding of those demands before screening began.
Our team discussed the protocol requirements with candidates in advance, including their willingness and ability to sustain the diary, challenge, and visit commitments. These conversations helped participants make an informed decision and arrive at screening with realistic expectations.
WCR screened 12 participants and enrolled and randomized 8, exceeding the original forecast of 6 by 33.3%. Four participants were screen failures. The 33.3% screen-failure rate was aligned with the study’s screen-failure rate.
Our team built relationships with participants throughout the trial and maintained open communication to support retention and compliance. All 8 randomized participants completed the entire study, with high compliance despite the demanding participation requirements.
The challenge. Our response.
The gluten challenge, diary requirements, and in-person visits required candidates to understand the full protocol and remain engaged throughout the trial.
The protocol required a gluten challenge, a significant consideration for people deciding whether to participate in a celiac disease trial.
Our team discussed the challenge requirement before screening, gave candidates room for questions, and explored their willingness and ability to take on the study commitment.
Diary requirements added work between visits and required consistent participant attention.
We set expectations before screening and maintained open communication throughout the trial. Participants had an ongoing relationship with the team to discuss questions and difficulties as they arose.
Repeated in-person visits had to fit alongside participants’ daily responsibilities over the full trial.
We discussed practical readiness during pre-screening and continued building relationships throughout participation. Visit planning and open communication supported follow-through, with all 8 randomized participants completing the trial.
33.3% above forecast. Eight randomized. Eight completed the entire trial.
The participant experience
Diary completion, a gluten challenge, and in-person visits made sustained participation central to this study. WCR paired careful pre-screening with ongoing relationships and open communication. All 8 randomized participants completed the entire trial.
Before screening, we discussed diary completion, the gluten challenge, and the in-person visit schedule so candidates understood what participation would involve.
Pre-screening included conversations about willingness and ability to meet the protocol’s requirements. Candidates could ask questions and consider the commitment before moving forward.
Our team continued building relationships and keeping communication open throughout the trial to support retention and compliance. Every randomized participant completed the study.
Practical participant support
We provide transportation support when needed to help participants attend study visits. We also discuss scheduling concerns early and maintain open communication throughout participation, helping address the practical barriers that can make follow-through difficult.
The result
Phase 2 · Celiac disease · WCR case study
Your next study
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