Alopecia Areata (AA) Case Study

Challenges

Solutions

Site engagement
Withdrawal of sites prior to / during SIV due to the complexity of the study

• • 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

Recruitment
Recruitment rates are below expectations. Sites in need of better support

• • 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

Central Laboratory
Over the holiday period, significant issues with samples were observed incl. shipping problems experienced by the Central Lab's vendor

• • 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