Use of likelihood estimates for variances for the design and evaluation of multiregional clinical trials with heterogeneous variances
學年 110
學期 1
出版（發表）日期 2021-10-27
作品名稱 Use of likelihood estimates for variances for the design and evaluation of multiregional clinical trials with heterogeneous variances
作品名稱（其他語言）
著者 Yuh‐Jenn Wu; Yu‐Chieh Cheng; Chieh Chiang; Li‐Hsueh Cheng; Ching‐Ti Liu; Chin‐Fu Hsiao
單位
出版者
著錄名稱、卷期、頁數 Statistics in Medicine 41 (1), 87-107
摘要 Globalized drug development studies, such as multiregional clinical trials (MRCTs), have attracted much attention due to their ability to expedite drug development and shorten the time lag of drug release. While observing the overall effect of a new drug, the region-specific effects to support drug registration in constituent regions can also be evaluated. Several challenges arise in conducting MRCTs, such as the heterogeneity in the variability of the primary endpoint across regions. However, most of the existing statistical methods assume a common variability, which may not be valid in practice due to differences across regions (eg, diversities in ethnicity or disparities in medical culture/practice). We present a statistical method for the design and evaluation of MRCTs to consider the heterogeneous variability across regions. We assessed the overall sample size requirement and addressed the region-specific sample size determination to establish the consistency of treatment effects between the specific region and the entire group. We demonstrate the proposed approach with numerical examples.
關鍵字 consistent trend;heterogeneity;multiregional clinical trial
語言 en
ISSN 1097-0258
期刊性質 國外
收錄於 SCI
產學合作
通訊作者 Chin‐Fu Hsiao
審稿制度 否
國別 GBR
公開徵稿
出版型式 ,電子版,紙本
相關連結

機構典藏連結 ( http://tkuir.lib.tku.edu.tw:8080/dspace/handle/987654321/121823 )