Europe's U-PGx Consortium Launches Landmark Multi-Gene Pharmacogenomics Implementation Trial
The Ubiquitous Pharmacogenomics Consortium designed PREPARE, a prospective block-randomized trial across seven European countries to evaluate whether pre-emptive panel-based pharmacogenomic testing reduces adverse drug reactions. Unlike previous single-gene studies, this is the first multi-center, multi-gene, multi-drug implementation study to assess the collective clinical utility and cost-effectiveness of guideline-based PGx testing in routine care. The program addresses a critical evidence gap that has stalled broader PGx adoption in Europe.
The original study
Implementing Pharmacogenomics in Europe: Design and Implementation Strategy of the Ubiquitous Pharmacogenomics Consortium.
- Authors
- van der Wouden CH, Cambon-Thomsen A, Cecchin E, Cheung KC, Dávila-Fajardo CL, Deneer VH, et al.
- Journal
- Clinical pharmacology and therapeutics
- Type
- Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
- PMID
- 28027596
Original abstract
Despite scientific and clinical advances in the field of pharmacogenomics (PGx), application into routine care remains limited. Opportunely, several implementation studies and programs have been initiated over recent years. This article presents an overview of these studies and identifies current research gaps. Importantly, one such gap is the undetermined collective clinical utility of implementing a panel of PGx-markers into routine care, because the evidence base is currently limited to specific, individual drug-gene pairs. The Ubiquitous Pharmacogenomics (U-PGx) Consortium, which has been funded by the European Commission's Horizon-2020 program, aims to address this unmet need. In a prospective, block-randomized, controlled clinical study (PREemptive Pharmacogenomic testing for prevention of Adverse drug REactions [PREPARE]), pre-emptive genotyping of a panel of clinically relevant PGx-markers, for which guidelines are available, will be implemented across healthcare institutions in seven European countries. The impact on patient outcomes and cost-effectiveness will be investigated. The program is unique in its multicenter, multigene, multidrug, multi-ethnic, and multihealthcare system approach.