At the time, this largest ALL trial ever for Inotuzumab Ozogamicin used to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia, had a target to enroll 292 patients in just 22 months.
Phesi’s Trial Accelerator™ platform, driven by the world’s largest trial database, was used to:
- Systematically analyze over 1,000 sponsored trials with a similar design, including much smaller ‘incomparable’ trials
- A Gross Site Enrollment Rate (GSER) of 0.067 patients per site per month, and a Site Effectiveness Index (a measure of site activation) of 60% was forecast
- Phesi recommended activating 120 sites and forecast a 36 month enrollment cycle time – more accurately predicting the required trial duration
The use of data-driven insight to select high performing sites resulted in an enrollment cycle time of 32 months and Inotuzumab ozogamicin, sold under the brand name Besponsa®, was approved by the FDA based on the results of this pivotal trial. Besponsa® was the first approved treatment for ALL.