Optimizing Trial Design Sequential, Adaptive, and Enrichment Strategies

被引:76
作者
Mehta, Cyrus [1 ,6 ]
Gao, Ping [5 ]
Bhatt, Deepak L. [3 ,4 ]
Harrington, Robert A. [2 ]
Skerjanec, Simona [5 ]
Ware, James H. [6 ]
机构
[1] Cytel Stat Software & Serv, Cambridge, MA 02139 USA
[2] Duke Clin Res Inst, Durham, NC USA
[3] Brigham & Womens Hosp, Boston, MA 02115 USA
[4] Vet Affairs Boston Healthcare Syst, Boston, MA USA
[5] Med Co, Parsippany, NJ USA
[6] Harvard Univ, Sch Publ Hlth, Boston, MA 02115 USA
关键词
CLINICAL-TRIALS;
D O I
10.1161/CIRCULATIONAHA.108.809707
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
[No abstract available]
引用
收藏
页码:597 / U199
页数:18
相关论文
共 12 条
[1]  
*CYT STAT SOFTW SE, 2008, E SOFTW ADV CLIN TRI
[2]   Sample Size Re-Estimation for Adaptive Sequential Design in Clinical Trials [J].
Gao, Ping ;
Ware, James H. ;
Mehta, Cyrus .
JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 2008, 18 (06) :1184-1196
[3]   DISCRETE SEQUENTIAL BOUNDARIES FOR CLINICAL-TRIALS [J].
LAN, KKG ;
DEMETS, DL .
BIOMETRIKA, 1983, 70 (03) :659-663
[4]  
MARCUS R, 1976, BIOMETRIKA, V63, P655, DOI 10.2307/2335748
[5]   Clinical aspects of platelet inhibitors and thrombus formation [J].
Meadows, Telly A. ;
Bhatt, Deepak L. .
CIRCULATION RESEARCH, 2007, 100 (09) :1261-1275
[6]   Flexible sample size considerations using information-based interim monitoring [J].
Mehta, CR ;
Tsiatis, AA .
DRUG INFORMATION JOURNAL, 2001, 35 (04) :1095-1112
[7]   Adaptive group sequential designs for clinical trials:: Combining the advantages of adaptive and of classical group sequential approaches [J].
Müller, HH ;
Schäfer, H .
BIOMETRICS, 2001, 57 (03) :886-891
[8]   MULTIPLE TESTING PROCEDURE FOR CLINICAL-TRIALS [J].
OBRIEN, PC ;
FLEMING, TR .
BIOMETRICS, 1979, 35 (03) :549-556
[9]   GROUP SEQUENTIAL METHODS IN DESIGN AND ANALYSIS OF CLINICAL-TRIALS [J].
POCOCK, SJ .
BIOMETRIKA, 1977, 64 (02) :191-200
[10]   Survival methods [J].
Rao, Sowmya R. ;
Schoenfeld, David A. .
CIRCULATION, 2007, 115 (01) :109-113