Clinical trials in pharmacogenomics and stratified medicine

Padmanabhan, S. (2014) Clinical trials in pharmacogenomics and stratified medicine. In: Padmanabhan, S. (ed.) Handbook of Pharmacogenomics and Stratified Medicine. Academic Press: London, pp. 309-320. ISBN 9780123868831 (doi: 10.1016/B978-0-12-386882-4.00015-3)

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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.

Item Type:Book Sections
Glasgow Author(s) Enlighten ID:Padmanabhan, Professor Sandosh
Authors: Padmanabhan, S.
Subjects:R Medicine > RM Therapeutics. Pharmacology
College/School:College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
Publisher:Academic Press
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