Protocol Design and Investigator Site Selection: Phase III Osteoarthritis Pain of the Knee Trial


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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