The Right EDC Solution For Oncology Trials

By Neil Vivian and Caterina Cammalleri, Anju Software

Oncology clinical trials are uniquely complex, logistically and ethically. Practically speaking, they often need mid-study changes and must adapt to subjects’ evolving health outcomes. Unfortunately, this can mean lengthy pauses during the study and excessive data cleaning on the back end. Meanwhile, these trials treat a particularly vulnerable population whose medical needs must be prioritized. Decentralized clinical trials (DCTs) are a humane approach that allows subjects to participate with minimal demands but requires complex data management. Selecting the right electronic data capture (EDC) system is crucial for managing oncology trials efficiently while providing compassionate care.

What Makes Oncology Trials Unique

Speed is of the essence in all clinical trials. Oncology trials, however, require expeditious turnaround times due to the severe nature of the diseases the subjects face. These studies’ data management needs are complex and can be slow to implement. Additionally, the study faces repeated delays if an EDC system does not build flexibility and adaptability in the design from the beginning.

For example, oncology trials frequently require repeating cycles in which a subject undergoes a cycle of therapy and is then evaluated as to whether they go through a repeat or a different cycle. Some EDCs require every cycle to be built out from the beginning, requiring mid-study changes if the subject needs a different cycle or dosage. Another hurdle with oncology studies is the need for unscheduled visits. A well-designed EDC system will accommodate these necessary unscheduled visits without needing mid-study changes.