Use of interval estimations in design and evaluation of multiregional clinical trials with continuous outcomes
學年 106
學期 1
出版（發表）日期 2018-01-22
作品名稱 Use of interval estimations in design and evaluation of multiregional clinical trials with continuous outcomes
作品名稱（其他語言）
著者 Chieh Chiang; Chin-Fu Hsiao
單位
出版者
著錄名稱、卷期、頁數 Statistical methods in medical research 28(7), p.2179-2195
摘要 Multiregional clinical trials have been accepted in recent years as a useful means of accelerating the development of new drugs and abridging their approval time. The statistical properties of multiregional clinical trials are being widely discussed. In practice, variance of a continuous response may be different from region to region, but it leads to the assessment of the efficacy response falling into a Behrens–Fisher problem—there is no exact testing or interval estimator for mean difference with unequal variances. As a solution, this study applies interval estimations of the efficacy response based on Howe’s, Cochran–Cox’s, and Satterthwaite’s approximations, which have been shown to have well-controlled type I error rates. However, the traditional sample size determination cannot be applied to the interval estimators. The sample size determination to achieve a desired power based on these interval estimators is then presented. Moreover, the consistency criteria suggested by the Japanese Ministry of Health, Labour and Welfare guidance to decide whether the overall results from the multiregional clinical trial obtained via the proposed interval estimation were also applied. A real example is used to illustrate the proposed method. The results of simulation studies indicate that the proposed method can correctly determine the required sample size and evaluate the assurance probability of the consistency criteria.
關鍵字 Multiregional clinical trial; interval estimation; sample size determination; Behrens–Fisher problem; consistency
語言 zh_TW
ISSN 0962-2802
期刊性質 國外
收錄於 SCI
產學合作
通訊作者
審稿制度 否
國別 GBR
公開徵稿
出版型式 ,電子版
相關連結

機構典藏連結 ( http://tkuir.lib.tku.edu.tw:8080/dspace/handle/987654321/122705 )