Outcomes
Innovaderm successfully transitioned this rescue study from another CRO and this resulted in:
- More than doubled patient enrollment in 1 month
- Started enrollment 1 month faster than initial projection
- All 5 newly added sites were actively recruiting
Study Characteristics
- Study Phase: IIa
- Study Type: Rescue study
- Patient Population: Generalized Pustular Psoriasis (GPP)
- IP Route of Administration: Systemic
- Original Sites at Rescue: 7 in 2 continents (4 North America, 3 Europe)
- Post Rescue Final Sites Distribution: 10 in 3 continents (7 Europe, 2 North America, 1 Asia)
Study Challenges
- GPP is the rarest form of psoriasis – Global prevalence of 1-9/1,000,000
- Patients had to be in flare in order to meet eligibility
- Most patients in North America and Central Europe well-managed on current SOC
- Only 2/7 legacy sites had recruited subjects – Only 30% of subjects enrolled when Innovaderm took over management
- Non-recruiting sites did not have target patient population in current clinical practice
- Global and regional Phase III trials competing for same population
Key Success Factors & Strategies
- Country and site selection
- PI Training
- Site engagement
- Regulatory Affairs
- Study Branding
Conclusion
- Extensive site and partner network: To identify the right sites in the right countries
- Years of experience with dermatology sites: To assess and rank sites based on recruitment & data quality and to focus on the sites most likely to make a difference in recruitment & assure data quality
Within a month of the new sites opening in Europe and Asia:
- Enrollment rates had more than doubled
- None of the legacy sites contributed to new enrollment
- Amid COVID, the Innovaderm team was able to activate two new countries in Europe and Asia, and complete enrollment faster than planned
