Global Experience In Complex Oncology Trials
Source: Kayentis

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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