Some Multiplicity Adjustment Procedures for Clinical Trials with Sequential Design and Multiple Endpoints

被引：0

作者：

Luo, Xiaodong ^{[1
]}

Quan, Hui ^{[1
]}

机构：

[1] Sanofi US, Biostat & Programming, 55 Corp Dr, Bridgewater, NJ 08807 USA

来源：

STATISTICS IN BIOPHARMACEUTICAL RESEARCH | 2024年 / 16卷 / 01期

关键词：

Generalized Simes inequality; Group-sequential p-values; Multiplicity; q-values; early submission; alpha-propagation; BONFERRONI PROCEDURE; TESTS;

D O I：

10.1080/19466315.2023.2191989

中图分类号：

Q [生物科学];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

This article proposes some new multiplicity adjustment procedures for clinical trials with multiple endpoints and multiple interim analyses. The proposed sequential procedures, adapting the popular multiple comparison procedures for fixed time-point design and using a-spending for each endpoint, are shown to strongly control the family-wise Type-1 error rate and provide powerful yet versatile multiplicity adjustment solutions for monitoring multiple endpoints via interim analyses.

引用

页码：104 / 115

页数：12

共 50 条

[41] Multiplicity considerations in the design and analysis of clinical trials
Cook, RJ
Farewell, VT
JOURNAL OF THE ROYAL STATISTICAL SOCIETY SERIES A-STATISTICS IN SOCIETY, 1996, 159 : 93 - 110
[42] A testing procedure in clinical trials with multiple binary endpoints
Ishihara, Takuma
Yamamoto, Kouji
COMMUNICATIONS IN STATISTICS-THEORY AND METHODS, 2023, 52 (02) : 273 - 282
[43] Interpreting tests for efficacy in clinical trials with multiple endpoints
OBrien, PC
Geller, NL
CONTROLLED CLINICAL TRIALS, 1997, 18 (03): : 222 - 227
[44] P-value adjustment in sequential clinical trials
Cook, TD
BIOMETRICS, 2002, 58 (04) : 1005 - 1011
[45] Some comments on frequently used multiple endpoint adjustment methods in clinical trials
Sankoh, AJ
Huque, MF
Dubey, SD
STATISTICS IN MEDICINE, 1997, 16 (22) : 2529 - 2542
[46] On the power of some sequential multiple testing procedures
Chen, Shiyun
Arias-Castro, Ery
ANNALS OF THE INSTITUTE OF STATISTICAL MATHEMATICS, 2021, 73 (02) : 311 - 336
[47] On the power of some sequential multiple testing procedures
Shiyun Chen
Ery Arias-Castro
Annals of the Institute of Statistical Mathematics, 2021, 73 : 311 - 336
[48] Endpoints in the design of clinical trials for primary sclerosing cholangitis
Ponsioen, Cyriel Y.
BIOCHIMICA ET BIOPHYSICA ACTA-MOLECULAR BASIS OF DISEASE, 2018, 1864 (04): : 1410 - 1414
[49] Are better endpoints and better design of clinical trials needed?
Fransen, J
van Riel, PLCM
BEST PRACTICE & RESEARCH IN CLINICAL RHEUMATOLOGY, 2004, 18 (01): : 97 - 109
[50] Design and Endpoints for Clinical Trials in Primary Sclerosing Cholangitis
Ponsioen, Cyriel Y.
Lindor, Keith D.
Mehta, Ruby
Dimick-Santos, Lara
HEPATOLOGY, 2018, 68 (03) : 1174 - 1188

← 1 2 3 4 5 →