To shorten enrollment cycle time and reduce costs with a data-led approach to optimize protocol design, reduce patient and site burden, and identify highest enrolling sites. The client also required competitor insights and a digital twin to support decision making.
- Generate a digital patient profile.
- 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 the CRO and 2 other industry data providers.
- Conduct a competitor trial analysis which revealed significant flaws in trial approach.
- Generate a digital twin which projected a 15% placebo effect.
- Predict that the trial needed 30-40% pain score reduction at Week 12 to demonstrate efficacy.
Phesi also recommended that the study team:
- Modify minimum age from 18 years to 40 years and BMI upper limit from 45 to 40.
- Activate sites in 8 or less countries; remove Russia/Ukraine from two pivotal trials.
- Run a Japanese bridge trial separately.
As a result of Phesi’s protocol design optimization and improved investigator site selection strategy, the sponsor reported that Phesi helped significantly reduce costs and accelerated development.
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