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
Challenge 1: Recruitment
Several screen failures (SF) due to late availability of lab results
Solutions
- 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
- Screen failure rate reduced due to early identification of lab errors and lab patients’ tests adequately screened
Challenge 2: Shipments
Transportation fees (i.e., couriers) especially for lab samples from countries outside European Union
Solutions
- 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
Challenge 3: Academic sites
Delay in start-up activities due to large proportion of academic sites in the study
Solutions
- 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
- Optimal site selection: experienced PIs in HS and experienced Innovaderm sites
- Implemented broad reach digital ad campaigns / assisted sites with the development of recruitment material
