Case Study

Global Experience In Complex Oncology Trials

Source: Kayentis
The Changing Oncology Landscape

eCOA challenges of oncology studies

  • Complex study design generates complex eCOA builds:
    • Numerous ePROs, eClinROs and eDiaries
    • Multi-modality therapy, multiple arms, multiple triggers
    • Numerous edit checks, large volume of data management activities
  • Frequent amendments •
    • Additional visits, inclusion/exclusion criteria modification, additional safety procedures
    • Implementation of amendments: 
      • Must happen remotely
      • Can vary significantly from one country to another (approval timelines)
  • Long study duration can affect patient engagement and site organization
    • Patient compliance can be affected by adverse events & perception of study burden over time
    • Sites progress in the study at a different pace, and site closures must happen in a staggered way
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