Protocol Design, Country and Investigator Site Selection: NSCLC


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.


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. 



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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