Global Experience In Complex Oncology Trials

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