著者

平川 晃弘 浅野 淳一 佐藤 宏征 手良向 聡

出版者

日本計量生物学会

雑誌

計量生物学 (ISSN:09184430)

巻号頁・発行日

vol.39, no.2, pp.85-101, 2019-01-31 (Released:2019-05-11)

参考文献数

62

被引用文献数

1 1

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In oncology, next generation sequencing and comprehensive genomic profiling have enabled detailed classification of tumors using molecular biology. It, however, may be unrealistic to conduct phase I-III trials according to each subpopulation based on the molecular subtypes. Common protocols that assess the combination of several molecular markers and their targeted therapies by means of multiple sub-trials are required. These protocols are called “master protocols,” and are drawing attention as a next-generation clinical trial design. In this review, we provide an overview of clinical trials based on master protocol including basket, umbrella, and platform trials along with their recent examples. We also discuss the statistical challenges encountered in their application.

著者

平川 晃弘 佐立 崚

出版者

日本小児血液・がん学会

雑誌

日本小児血液・がん学会雑誌 (ISSN:2187011X)

巻号頁・発行日

vol.56, no.5, pp.432-435, 2019 (Released:2020-02-07)

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ランダム化比較試験の主たる目的は,対象集団に対する治療効果の検証である.ランダム化比較試験では,治療効果を正しく評価するための統計的な工夫や方策がいくつかある.本稿では,ランダム化,盲検化,評価項目,サンプルサイズ,解析対象集団に焦点を当て,ランダム化比較試験における統計的要点について解説する.

著者

河津 優太 土田 潤 安藤 宗司 平川 晃弘 寒水 孝司

出版者

日本計量生物学会

雑誌

計量生物学 (ISSN:09184430)

巻号頁・発行日

vol.42, no.1, pp.55-64, 2021 (Released:2022-04-22)

参考文献数

11

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Phase I oncology clinical trials are designed to evaluate the safety of test drug/s and to determine the recommended dose for subsequent trials. However, the method to determine the required number of participants (sample size) has not been sufficiently developed for these dose-finding studies. The usual approach involves time-consuming calculations using numerical experiments to establish the required sample size that will allow the determination of accurate recommended dose of the test drug/s. In this study, we propose a time-saving method to determine the sample size. This method uses an alternative index of the proportion to accurately select the recommended dose. In the numerical experiments, we compared the performances (sample size, proportion of correctly selected recommended dose, and calculation time for the determination of sample size) of the proposed method with those of the conventional method. The sample size and the proportion of correctly selected recommended dose, determined by the proposed method, were slightly different from those calculated using the conventional method. The calculation time of the proposed method was consistently shorter than that of the conventional method. These results suggest that the proposed method can be used to roughly estimate the sample size of phase I oncology studies.