Phase IIb Inflammatory Bowel Disease Trial

Challenge

In inflammatory bowel disease trials, endoscopic and cross-sectional assessments of disease activity are inherently interpretive. When scoring is performed at individual sites, that subjectivity translates directly into variability: the same endoscopic finding may be scored differently by different investigators, and eligibility decisions can diverge accordingly. The sponsor needed to remove this inconsistency from both the screening process and the SES-CD and Mayo Endoscopic Score assessments that anchored the trial's efficacy evaluations.

Our Solution

Intrinsic Imaging established a blinded dual-reader central review process encompassing both endoscopic video and MR enterography. Endoscopic recordings were anonymized and scored against standardized ulcer measurement conventions, while cross-sectional studies underwent quantitative review of bowel wall thickness and related parameters. Discordant scores were resolved through structured adjudication, and centralized eligibility review brought uniformity to screening decisions across all participating sites.

Results

• Inter-reader scoring discordance reduced by 42%
• Reduced incidence of inappropriate screening exclusions
• Consistent eligibility decisions across sites