[Continual reassessment method (CRM)].
We discuss the basic concept of the continual reassessment method (CRM) and some modifications. The CRM has been proposed as alternatives of traditional cohort design for phase I trials in cancer. To focus on the dilemma between ethical concern and scientific purpose, we review the requirement for the phase I settings and the issues of the traditional cohort design. Then, CRM is introduced so that the essential feature is in the sequential (continual) selection of a dose level for next patients based on the dose-toxicity relationship and in updating the relationship based on patients' response date using Bayesian calculation. Finally we discuss both advantages and pitfalls in practice.
Ishizuka
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Division of Cancer Information & Epidemiology, National Cancer Center Research Institute.
D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D017321:Clinical Trials, Phase I as Topic / Q000379:methods / Q000592:standards* / Q000639:trends; D005544:Forecasting; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D012107:Research Design / Q000592:standards
D000970:Antineoplastic Agents