CHALLENGE:

The sponsor of a Phase III Follicular Lymphoma trial needed a data-led approach to optimize protocol design and identify highest enrolling sites. Competition for patients was very 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
  • Assess the operational impact from key protocol design elements on enrollment cycle time, country and investigator site selection
  • Identify top enrolling investigator sites
  • Critically appraise investigator site recommendations from two leading CROs
  • Conduct a competitor trial analysis

Phesi also recommended that the study team:

  • Activate a total of 185 sites to enroll 528 patients in 31 months
  • Use a two-batch approach to achieve a target site activation performance of >64%
  • Activate 120 sites first and use recruitment modeling (including peak performance analysis) to establish when to activate new sites to deliver the shortest cycle time

THE DATA:

IMPACT:

Phesi’s approach supported internal decision making and was used to guide discussions on reducing patient and investigator site burden, cost and trial duration.

 

 

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