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.
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
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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