Pharmacogenetics in randomized controlled trials: considerations for trial design

被引：0

作者：

van der Baan, Frederieke H. ^{[1
,2
]}

Klungel, Olaf H. ^{[1
,2
]}

Egberts, Antoine C. G. ^{[2
,3
]}

Leufkens, Hubert G. ^{[2
,4
]}

Grobbee, Diederick E. ^{[1
]}

Roes, Kit C. B. ^{[1
]}

Knol, Mirjam J. ^{[1
,2
]}

机构：

[1] Univ Med Ctr Utrecht, Julius Ctr Hlth Sci & Primary Care, NL-3508 GA Utrecht, Netherlands

[2] Univ Utrecht, Div Pharmacoepidemiol & Clin Pharmacol, Fac Sci, Utrecht Inst Pharmaceut Sci, Utrecht, Netherlands

[3] Univ Med Ctr Utrecht, Dept Clin Pharm, NL-3508 GA Utrecht, Netherlands

[4] Med Evaluat Board, The Hague, Netherlands

来源：

PHARMACOGENOMICS | 2011年 / 12卷 / 10期

关键词：

clinical trial; evidence; genotype; pharmacogenetics; pharmacogenomics; study design; CYTOCHROME-P450; 2D6; SUBGROUP ANALYSES; BREAST-CANCER; PHASE-III; GENOTYPE; CHEMOTHERAPY; DEPRESSION; BIOMARKERS; BENEFIT; READY;

D O I：

10.2217/PGS.11.95

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Pharmacogenetic analyses of clinical trials aim to either detect whether a subgroup of patients identified by genetic characteristics responds differently to the treatment or to verify whether a proposed genotype-guided treatment is beneficial over standard care. This article describes three different trial designs, differing in the timing of randomization and genotyping. Each design has its own advantages, and the objectives and conditions under which each one is most suited are discussed.

引用

页码：1485 / 1492

页数：8

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