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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