Palmoplantar Pustulosis (PPP) Rescue Case Study

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Outcomes

Innovaderm successfully transitioned this rescue study from another CRO and this resulted in:

Increase in enrollment of over 10x
Tripled site performance post transition
On-time patient recruitment

Study Characteristics

• Study Phase: II
• Study Status: Rescue study
• Patient Population: Palmoplantar pustulosis (PPP)
• IP Route of Administration: Systemic
• Original Sites at Rescue: 20 in 2 countries (USA, CAN)
• Post Rescue Final Sites Distribution: 40 in 4 countries (US, CAN, GER and POL)

Study Challenges

Only 3/20 legacy sites had recruited subjects over a period of almost one year

• • Only 8% of subjects enrolled when Innovaderm took over study in Dec 2019
  • Legacy sites did not have target patient population in current clinical practice
  • Low motivation at legacy sites when Innovaderm took over
  • COVID 19 restrictions impacting sites as of March 2020

Key Success Factors & Strategies

Country and site selection

PI training

Site activation

Site engagement

Study awareness

Recruitment Curve and Site Activation

Site Performance before and after transitioning to Innovaderm

Performance of sites from other CRO tripled after transitioning to Innovaderm

Innovaderm had the most performant sites

Our Key to Success

• 1. To identify the top sites in the right locations (i.e., country)
     
     
  2. Years of experience with dermatology sites
     • To focus on the sites most likely to make a difference in recruitment and assure quality data
       
       
  3. Site Engagement
     • Use the momentum of activation to quickly bring FPI to each site
     • CRAs in close contact with site throughout the study

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