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Clinical Trial Designs to Support Clinical Utility of Pharmacogenomic Testing
Author(s) -
Drozda Katarzyna,
Pacanowski Michael A.
Publication year - 2017
Publication title -
pharmacotherapy: the journal of human pharmacology and drug therapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.227
H-Index - 109
eISSN - 1875-9114
pISSN - 0277-0008
DOI - 10.1002/phar.1971
Subject(s) - clinical trial , pharmacogenomics , clinical study design , medicine , intensive care medicine , pharmacology
Advancing the use of biomarkers and pharmacogenomics has been a key priority area for the U.S. Food and Drug Administration ( FDA ). The FDA offers prescribing recommendations to manage ~100 gene‐drug interactions, and multiple institutions around the United States and abroad have incorporated genomic testing into patient care. However, the penetration of pharmacogenomic testing remains incomplete. In this perspective, we summarize the evidence streams to support the clinical utility of pharmacogenomic testing and its transition into clinical practice.