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Clinical trial 

Clinical trial
Chapter:
Clinical trial
Author(s):

Michael Gonzalez

, Khurum Khan

, and Bristi Basu

DOI:
10.1093/med/9780199664535.003.0028
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date: 20 August 2019

Before approval for clinical use, cancer drugs undergo rigorous evaluation through clinical trials. There are number of phases of clinical trials. In the preclinical stage, potential agents are screened and tested on animal models. Phase I studies are the first human application of a new drug or drug combination to determine the safety and tolerability. After the determination of the maximal tolerated dose, the new drug proceeds to phase II study to assess the efficacy. Phase III study is to establish the efficacy of new treatment compared with the existing standard treatment, observation or placebo.

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