Takayoshi Kiba
It is important to investigate whether other clinical endpoints, such as response rate, disease stabilization rate, or progression free survival could replace overall survival as the primary endpoint for the patients with advanced or metastatic cancer. Before a surrogate end point can replace a so-called 'true' end point of interest, it must be formally validated, a process that has caused considerable controversy in the past two decades. The aim of this review manuscript is to discuss some of the limitations encountered when survival is used as the primary study end point for evaluating the efficacy or effectiveness in phase II or III trials for advanced or metastatic cancer tumors.
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