Hidradenitis Suppurativa (HS) Case study

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Outcomes

Innovaderm successfully managed this HS study
and this resulted in:

Enrollment completed 3 months ahead of schedule


 

Study Characteristics

    • Study Phase: II
  • Patient Population: Hidradenitis Suppurativa
  • IP Route of Administration: Systemic - Subcutaneous
  • Site distribution: 25 in North America and 16 in Europe

 


 

Study Challenges and Solutions

 

Challenges

Solutions

 

Recruitment
Several screen failures (SF) due to late availability of lab results

    • Pro-active monitoring of lab results regarding patients’ eligibility by project team
    • Flagged alerts to individual sites and follow-up with central lab on unexpected delays

Outcome: Screenfailure rate reduced due to early identification of lab errors and lab patients’ tests adequately screened

Phone job interview

 

Shipments
Transportation fees (i.e., couriers) especially for lab samples from countries outside European Union

    • Thorough assessment of cost drivers for shipment frequencies (sample stability and required turn-around time to obtain results)
    • Regrouping of shipments and modification to the lab panel to respect budgeted fees

Outcome: Significant reduction in shipping costs

 

Academic sites
Delay in start-up activities due to large proportion of academic sites in the study

    • Frequent, tailored 1:1 calls with PIs prior to study initiation
    • Site-centricity (i.e., involvement from onset of study)

Outcome: Early-stage discussions with PIs helped streamlined recruitment and start-up timelines


 

Key Success Factors & Strategies

Phone interview icon Optimal site selection: experienced PIs in HS and experienced Innovaderm sites

Site engagement Implemented broad reach digital ad campaigns / assisted sites with the development of recruitment material

 


 

Recruitment Curve

 

Enrollment completed 3 months ahead of schedule

 

 

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