Enhancing clinical research with pharmacogenomics: a practical perspective

Pharmacogenomics (PGx) is transforming therapeutic development by providing insights into how genetic variations influence drug response, safety, and efficacy. This review provides a structured analysis of PGx in clinical research, beginning with an overview of key genes involved in drug metabolism, transport, and targets. Following this, it examines strategies for identifying PGx-relevant genes, including phenotype-driven, hypothesis-driven, population-focused, and clinical-driven approaches. Technical platforms such as PCR, MassARRAY, and next-generation sequencing are analyzed for their suitability in PGx studies. The discussion then shifts to assay validation processes, covering both analytical and clinical validation, to ensure data reliability in clinical trials. Finally, regulatory expectations for PGx in clinical trials are discussed, focusing on key requirements across all phases of drug development. This review aims to provide a clear and practical framework for integrating PGx into clinical research to enhance drug safety, efficacy, and personalized medicine.