Journal
PHARMACOGENOMICS
Volume 12, Issue 10, Pages 1485-1492Publisher
FUTURE MEDICINE LTD
DOI: 10.2217/PGS.11.95
Keywords
clinical trial; evidence; genotype; pharmacogenetics; pharmacogenomics; study design
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Funding
- Dutch Top Institute Pharma [T6-202]
- Division of Pharmacoepidemiology and Clinical Pharmacology
- GlaxoSmithKline
- Novo Nordisk
- Top Institute Pharma
- Dutch Medicines Evaluation Board
- Dutch Ministry of Health
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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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