Leveraging Human Genetics to Identify Safety Signals Prior to Drug Marketing Approval and Clinical Use.

ABSTRACT:

Introduction

When a new drug or biologic product enters the market, its full spectrum of side effects is not yet fully understood, as use in the real world often uncovers nuances not suggested within the relatively narrow confines of preapproval preclinical and trial work.

Objective

We describe a new, phenome-wide association study (PheWAS)- and evidence-based approach for detection of potential adverse drug effects.

Methods

We leveraged our established platform, which integrates human genetic data with associated phenotypes in electronic health records from 29,722 patients of European ancestry, to identify gene-phenotype associations that may represent known safety issues. We examined PheWAS data and the published literature for 16 genes, each of which encodes a prot

SUBMITTER: Jerome RN 

PROVIDER: S-EPMC7398579 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature