CHALLENGE:
The sponsor of an early phase, industry landmark (KEYNOTE-21) NSCLC trial needed a data-led approach to optimize protocol design and identify highest enrolling countries and sites. Competition for patients was high.
SOLUTION:
Phesi’s Trial Accelerator™ platform, driven by the world’s largest trial database, was used to:
- Analyze and optimize key protocol design elements (ECOG performance status, disease stage, life expectancy and after steroid use).
- Assess the operational impact from key protocol design elements on enrollment cycle time, country and investigator site selection.
- Identify top enrolling investigator sites.
- Baseline analysis of 550 NSCLC trials showed that enrollment cycle time was 750 days for this complex, early phase trial.
- Through identification of highest performance sites using the Phesi platform ECT was forecast at 650 days.
- Patient enrollment completed in 670 days.
THE DATA:
IMPACT:
Phesi’s approach supported internal decision making on design, selection of highest enrolling countries and investigator sites and accurate forecast of enrollment cycle time in this landmark study.
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