Outcomes
- Innovaderm’s outstanding support on this alopecia areata study resulted in a rapid increase in enrollment rates and the successful management of this trial
Study Characteristics
- Study Phase: II
- Patient Population: Alopecia Areata
- IP Route of Administration: Systemic
- Sites distribution: 12 sites (CAD-USA)
- Complex study procedures: Ophthalmology and Pulmonary function tests
Study Challenges and Solutions
Challenge 1: Site Engagement
Withdrawal of sites prior to / during SIV due to the complexity of the study
Solutions
- More robust FQ and discussions during SQV ensured PI/sites had a clear understanding of the logistical needs to implement the study, as well as required resources
Outcome
- Decrease in withdrawal of sites
Challenge 2: Recruitment
- Recruitment rates are below expectations. Sites in need of better support
Solutions
- Conducted frequent 1:1 calls and follow-ups with sites to review recruitment plans
- Assisted with extensive tracking of referrals, follow through and outcomes
- Shared other sites’ practices on effective local recruitment initiatives
Outcome
- Renewed efforts in recruiting led to screening activity increased within 2 weeks of the 1:1 site calls
Challenge 3: Central Laboratory
- Over the holiday period, significant issues with samples were observed incl. shipping problems experienced by the Central Lab’s vendor
Solutions
- Re-trained sites on best practices for processing samples
- Increased sample stability
- PM engaged in frequent communications with lab to proactively discuss possible delays in shipping
Outcome
- >50% reduction in related issues regarding samples exceeding stability or being inadequate for processing
Key Success Factors & Strategies
- Bi-weekly calls between CRAs & sites to focus on recruitment
- Implemented 1:1 site booster calls to discuss specific challenges
