[Guideline for phase I study on new anticancer agents].
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.
Shimoyama
M
M
Nagoya National Hospital, 4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan.
D000970:Antineoplastic Agents / Q000627:therapeutic use*; D017321:Clinical Trials, Phase I as Topic / Q000592:standards*; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy
D000970:Antineoplastic Agents