Since more than 50% of patients with cancer could no be cured by present standard therapy, new effective anticancer agents are needed in clinical level. In the evaluation of new anti-cancer agents by phase I study, there are several important and specific issues from scientific, medical, statistical, and ethical view points. Clinical safety data management is critically important in phase I study. This paper shows major parts of a report entitled "Guideline for phase I study on new anticancer agents", already published in JPs Pharmacol Ther 26: 441-454, 1998, with minor modification in order to answer these issues.
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