Alopecia Areata Case Study

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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

 

Challenges

Solutions

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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

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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

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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


 

Key Success Factors & Strategies

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