婦人科悪性腫瘍とクリニカルトライアル

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Clinical trials have been developed tremendously in oncology because of its clear endpoints. In Japan, however, a concept of clinical trial has not been so accepted for long time. Recently, Minister of Health and Welfare anounced guide lines of clinical evaluation of anticancer drug and statistical analysis. Elements essential to design of clinical trials are following ; the first element is a clearly stated hypothesis. The hypothesis must be testable, that is, the investigator must have a clear idea of how these differences will be determined in this study subjects. The trial must have a well documented protocol and have a well defined primary endpoint by which the anticipated effect of the new treatment will be evaluated. Although one or two secondary endpoints may also be identified in the trial, the primary endpoint is the major focus of the trial and determines trial design, size, and early stopping rules. The clinical trial must be appropriately designed so that the hypothesis can be adequately tested and evaluated. The study may compare the new therapy to a standard treatment or assess the basic characteristics of the treatment. The clinical trial must be designed so that adequate sensitivity (significance level) and power to provide a high degree of confidence that results are not spurious. The next critical aspect to the performance of a successful clinical trial is the ability to acrue adequate numbers of patients within a reasonable period of time for the study to be compeleted. The next essential element to the design of a clinical trial is the prospective selection of statistical tool appropriate to the data to be collected. Prematuarity of Japanese clinical trial is not only due to the level of concern by physicians but also due to misunderstand about the concept of clinical trial. It is urgent to educate medical and paramedical staff, and to open training courses for biostatistician and data manager. It is also very important to establish a statistical center for clinical oncology in order to develop significant clinical trial in Japan.
社団法人日本産科婦人科学会の論文
1993-08-01

婦人科悪性腫瘍とクリニカルトライアル

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