Clinical Trial Design

Clinical trials aim to identify effective drugs for further studies, while also allowing discontinuation of ineffective drugs in an ethical and efficient way. Traditional phase I/II/III clinical trials for cytotoxic agents assume that (1) the agent will reduce the size of the tumor in a dose-dependent manner;

(2) the agent will have toxicities that are dose dependent; and

(3) reduction in tumor size will lead to improved overall survival and/or improved quality of life. In contrast, newer targeted agents may not have an objective effect on tumor size other than tumor stabilization or metastasis prevention. There may not be a dose-dependent effect, and toxicities may only be modest.113 Consequently, there are limitations in testing target-based agents with conventional trials designed for cytotoxic drugs, and alternative endpoints/trial designs are required.

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