publication date: Nov. 22, 2019
Conversation with The Cancer Letter
Friends’ Allen: Real-world endpoints can be used to fill evidence gaps about performance of medical products
President and CEO,
Friends of Cancer Research
If real-world endpoints are indeed accurate proxies for clinical trial endpoints, real-world endpoints should start to look increasingly similar to the clinical trial endpoints as more stringent criteria are applied, said Jeff Allen, president and CEO of Friends of Cancer Research.
Friends has published a set of common definitions for real-world endpoints, including overall survival, progression-free survival, and other non-traditional endpoints. The project focuses on patients with advanced non-small cell lung cancer who received immune checkpoint inhibitors.
“By running these analyses in parallel with 10 different partners, we’re able to identify different data characteristics, such as the histological distribution within each dataset, that can influence the outcomes measured,” Allen said.
“We have also been cognizant of how disease setting, practice patterns, and specific treatment regimens would impact the meaningfulness of the real-world endpoints that we used and tried to account for those possible differences in our framework.”
The pilot project is ongoing: the collaboration will focus on applying inclusion/exclusion criteria in order to isolate clinical trial “eligible” real-world patients and compare outcomes of both groups.
Allen spoke with Matthew Ong, associate editor of The Cancer Letter.