Pharmacogenetics in randomized controlled trials: considerations for trial design

F.H. van der Baan; O.H. Klungel; A.C.G. Egberts; H.G.M. Leufkens; D.E. Grobbee; K.C.B. Roes; M.J. Knol

doi:10.2217/pgs.11.95

Pharmacogenetics in randomized controlled trials: considerations for trial design

F.H. van der Baan, O.H. Klungel, A.C.G. Egberts, H.G.M. Leufkens, D.E. Grobbee, K.C.B. Roes, M.J. Knol

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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.

Original language	English
Pages (from-to)	1485-92
Number of pages	8
Journal	Pharmacogenomics
Volume	12
Issue number	10
DOIs	https://doi.org/10.2217/pgs.11.95
Publication status	Published - 2011

Keywords

Genotype
Genotyping Techniques
Humans
Pharmacogenetics
Randomized Controlled Trials as Topic
Research Design
Translational Medical Research
Journal Article
Research Support, Non-U.S. Gov't

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10.2217/pgs.11.95

http://www.ncbi.nlm.nih.gov/pubmed/22008051

Cite this

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title = "Pharmacogenetics in randomized controlled trials: considerations for trial design",

abstract = "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.",

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year = "2011",

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T2 - considerations for trial design

AU - van der Baan, F.H.

AU - Klungel, O.H.

AU - Egberts, A.C.G.

AU - Leufkens, H.G.M.

AU - Grobbee, D.E.

AU - Roes, K.C.B.

AU - Knol, M.J.

PY - 2011

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AB - 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.

KW - Genotype

KW - Genotyping Techniques

KW - Humans

KW - Pharmacogenetics

KW - Randomized Controlled Trials as Topic

KW - Research Design

KW - Translational Medical Research

KW - Journal Article

KW - Research Support, Non-U.S. Gov't

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DO - 10.2217/pgs.11.95

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SP - 1485

EP - 1492

JO - Pharmacogenomics

JF - Pharmacogenomics

IS - 10

ER -

Pharmacogenetics in randomized controlled trials: considerations for trial design

Abstract

Keywords

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