教師資料查詢 | 類別: 期刊論文 | 教師: 姜 杰CHIANG, CHIEH (瀏覽個人網頁)

標題: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
語言英文
ISSN1097-0258
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
國別英國
公開徵稿
出版型式,電子版,紙本
相關連結
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