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- W34458021 abstract "Pharmacogenetic and stratified medicine research investigates the causal role of genetic variability in the interindividual variability in response to treatment and adverse drug effects. Identifying patients who are probable non-responders to the standard dosing regimen and/or patients with an increased risk of adverse drug reactions has a major impact on the benefit–risk ratio of a drug at an individual level. However, identification of genetic markers associated with drug response does not always equate to clinically useful predictors of adverse outcomes, and independent replication of genotype-phenotype association is always required before pursuing clinical implementation. Pharmacogenomic or stratified medicine clinical trial seeks determine if the treatment effect of a drug varies between subjects with different genotypes and the cost:benefit ratio of genotype-guided treatment over standard care. In this chapter, the fundamentals of clinical trials are provided with specific focus on how pharmacogenomic or stratified medicine clinical trial require newer approaches in contrast to the established and common benchmark for interventional evidence in medicine—the randomised controlled trial." @default.
- W34458021 created "2016-06-24" @default.
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- W34458021 date "2014-01-01" @default.
- W34458021 modified "2023-09-23" @default.
- W34458021 title "Clinical Trials in Pharmacogenomics and Stratified Medicine" @default.
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- W34458021 doi "https://doi.org/10.1016/b978-0-12-386882-4.00015-3" @default.
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