{"title":"基于处理差异中期估计的增加样本量的50%条件功率法的修正","authors":"K. Uemura, Y. Matsuyama, Y. Ohashi","doi":"10.5691/JJB.29.19","DOIUrl":null,"url":null,"abstract":"Recently, flexible approaches with updating of sample size during the course of clinical trials have been proposed; the weighted Z-statistic approach and the 50 %-conditional power approach. In this paper, we propose a modification of the 50 %-conditional power approach, which increases the sample size only when the conditional power based on the unblinded interim results is greater than 50 %. Our method can control the type I error rate due to the restriction on the minimum required sample size ratio under the decision of increasing sample size. Simulation studies showed that the proposed method increased power about 10 % compared with the fixed sample size design and attained higher power than the original 50 %-conditional power approach. Compared with the weighted Z-statistic approach, the proposed method had several promising operating characteristics; a substantial gain in conditional power given the decision of sample size adjustment, a low probability of reaching the maximum sample size, a substantial decrease in the conditional type II error rate given the maximum sample size, and a conservative property of not increasing sample size erroneously under no treatment effect.","PeriodicalId":365545,"journal":{"name":"Japanese journal of biometrics","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2008-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"2","resultStr":"{\"title\":\"A Modification of the 50 %-Conditional Power Approach for Increasing the Sample Size Based on an Interim Estimate of Treatment Difference\",\"authors\":\"K. Uemura, Y. Matsuyama, Y. Ohashi\",\"doi\":\"10.5691/JJB.29.19\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Recently, flexible approaches with updating of sample size during the course of clinical trials have been proposed; the weighted Z-statistic approach and the 50 %-conditional power approach. In this paper, we propose a modification of the 50 %-conditional power approach, which increases the sample size only when the conditional power based on the unblinded interim results is greater than 50 %. Our method can control the type I error rate due to the restriction on the minimum required sample size ratio under the decision of increasing sample size. Simulation studies showed that the proposed method increased power about 10 % compared with the fixed sample size design and attained higher power than the original 50 %-conditional power approach. Compared with the weighted Z-statistic approach, the proposed method had several promising operating characteristics; a substantial gain in conditional power given the decision of sample size adjustment, a low probability of reaching the maximum sample size, a substantial decrease in the conditional type II error rate given the maximum sample size, and a conservative property of not increasing sample size erroneously under no treatment effect.\",\"PeriodicalId\":365545,\"journal\":{\"name\":\"Japanese journal of biometrics\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2008-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Japanese journal of biometrics\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.5691/JJB.29.19\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Japanese journal of biometrics","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.5691/JJB.29.19","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
A Modification of the 50 %-Conditional Power Approach for Increasing the Sample Size Based on an Interim Estimate of Treatment Difference
Recently, flexible approaches with updating of sample size during the course of clinical trials have been proposed; the weighted Z-statistic approach and the 50 %-conditional power approach. In this paper, we propose a modification of the 50 %-conditional power approach, which increases the sample size only when the conditional power based on the unblinded interim results is greater than 50 %. Our method can control the type I error rate due to the restriction on the minimum required sample size ratio under the decision of increasing sample size. Simulation studies showed that the proposed method increased power about 10 % compared with the fixed sample size design and attained higher power than the original 50 %-conditional power approach. Compared with the weighted Z-statistic approach, the proposed method had several promising operating characteristics; a substantial gain in conditional power given the decision of sample size adjustment, a low probability of reaching the maximum sample size, a substantial decrease in the conditional type II error rate given the maximum sample size, and a conservative property of not increasing sample size erroneously under no treatment effect.