24 September 2017

Case Study: Knee Osteoarthritis

Smart countries selection and effective project management lead to 100% of recruitment on time.

Background

A clinical endpoint study to prove bioequivalence of a topical agent administered in adult patients suffering from Knee Osteoarthritis. The study involved a full scope of services, including Feasibility and Site Selection process, Sites Set-up and Contracting, Study Authorization, Clinical Monitoring, Medical Monitoring, as well as Data Management and Project Management.

 

Challenges

 

Solutions

  • 4 CEE countries selected for the project execution, with vast recruitment potential and relatively low GDP per capita: Poland, Hungary, Romania and Ukraine
  • Careful sites selection process, choosing motivated investigators with capacity to enroll large number of patients in parallel
  • Effective project management and set-up process, leading to no delays in sites activation
  • Investigators’ meeting for investigators from 4 countries and efficient trainings
  • Regular thorough clinical monitoring, ensuring proper quality of data
  • Implemented 24/7 operational execution management style
  • Close operation with Sponsor’s team from US

 

Results

  • 1434 pts screened/ 1217 pts randomized - 100 % recruitment goal met on time
  • 41 contracted and actively recruiting sites within 4 countries
  • Screen failure rate significantly lower than initially assumed
  • Contracted milestones achieved on time

 

Tools

KCR Trial Execution