title: Mobilizing pharmacogenomic analyses during clinical trials in drug development.
abstract: The utilization of pharmacogenomics (PGx) in drug development is increasing as pharmaceutical companies and regulatory agencies work to understand variation in response to medications. The implementation of PGx in clinical trials requires a number of considerations that begin early at the point of program development for a compound. This article will discuss the issues involved in mobilizing a PGx study during the conduct of a clinical trial, including the development of a PGx hypothesis, the identification of genetic markers for analysis, PGx platform selection and assay development, as well as challenges that arise in relation to global laws and regulations related to genetic research and logistical/timeline concerns in the execution of a PGx analysis.
authors.affiliation: Merck & Co., Inc., Clinical Pharmacogenomics & Clinical Specimen Management, 2015 Galloping Hill Road, K15-4045, Kenilworth, NJ 07033, USA. karina.bienfait@merck.com
authors.forename: Karina L
authors.initials: KL
authors.lastname: Bienfait
authors.forename: Peter M
authors.initials: PM
authors.lastname: Shaw
authors.forename: Gowri
authors.initials: G
authors.lastname: Murthy
authors.forename: Amelia Wall
authors.initials: AW
authors.lastname: Warner
mesh_terms: D002986:Clinical Trials as Topic; D055808:Drug Discovery; D005819:Genetic Markers; D006801:Humans; D010597:Pharmacogenetics / Q000379:methods*
chemical_list: D005819:Genetic Markers