New endpoints for early-stage cancer are gaining regulatory traction

Using the standard regulatory endpoints of overall survival (OS) and progression-free survival (PFS) may not be feasible in some early-stage cancer trials due to the time it would take to reach the number of patient deaths and disease progression events to demonstrate efficacy. Novel endpoints that can offer quicker insights into the short- or long-term clinical benefits of new cancer drugs are needed, especially for early-stage cancer and immediately before (neoadjuvant) and after (adjuvant) primary treatment. This article covers three promising new endpoints.


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