The trial was struggling to secure sites, decline rates were high, and too few potentially eligible patients were making it through screening — prompting the need for a rescue plan.
CASE STUDY | APR 14, 2026
Trial Rescue & Reconnaissance
This project required multiple assessments. See how Citeline dug deep to uncover protocol constraints, develop country and site strategy, research competitive intensity, and identify real-world patient patterns.
FAQ
What problem was Biorasi trying to solve in this Phase III oncology trial?
What were the two hypotheses Citeline helped validate?
Citeline helped Biorasi assess whether (1) the sponsor was targeting the wrong sites, or (2) the protocol design was creating barriers for investigators and patients.
What outcomes did the analysis deliver?
The work confirmed the sponsor was generally on the right track with sites. Citeline identified 199 additional high-quality US sites and eight countries for potential expansion. Its analysis supported a protocol amendment projected to boost enrollment 15% to 20%.
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