Ohashi Y
Dept. of Biostatistics and Epidemiology, School of Health Sciences and Nursing, University of Tokyo.
Gan To Kagaku Ryoho. 1994 Oct;21 Suppl 3:292-4.
Statistical designs for early stage cancer clinical trials, which include continual reassessment method for phase I and I-II studies, early stopping of phase II studies, randomized phase II and multi-stage phase II studies, are shortly reviewed. These recent proposals should be examined further as regards to their statistical characteristics as well as their ethical implication.
对早期癌症临床试验的统计设计进行了简要回顾,这些设计包括用于I期和I-II期研究的连续重新评估方法、II期研究的早期终止、随机II期和多阶段II期研究。这些最新提议应在统计特征及其伦理意义方面进行进一步审查。