Using Novel Endpoints to Transform Oncology Clinical Trials

Posted by Malik Kaman on Jun 28, 2018 8:00:00 AM

Joshua Hattem and Matt Furlow co-authored this post with Malik Kaman.

To match the rapid changes occurring in cancer therapy development, oncology clinical trials are making a few changes of their own. As contemporary clinical trials break with tradition by infusing new, or different, outcome measures to better assess clinical efficacy, the results are encouraging: Single-arm phase I/II trials are gaining accelerated approvals using overall response rate (ORR) and duration of response (DoR) as proxies for survival and 72% of the oncology treatments reviewed by the FDA since 2006 gained approval based on response rate and progression-free survival endpoints.

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