Clinical Pharmacology & Therapeutics · 2016 · 292 citations · 60 references
MedicinePharmacoeconomicsPharmacologyClinical PharmacologyPharmacogeneticsPharmacogenomicsClinical Implementation Of PharmacogeneticsClinical Implementation Of PharmacogenomicsClinical TrialsPharmacogenomic BiomarkersPharmacogenomic TestingClinical Translation Of PharmacogenomicsClinical Utility AssessmentClinical Utility Of Pharmacogenomic TestingCollective UtilityHealthcare InstitutionsPreemptive Pharmacogenomic ScreeningPreemptive Pharmacogenomic TestingPreemptive Pharmacogenomics
Pharmacogenomics has advanced scientifically and clinically, yet its routine application remains limited by a lack of evidence for the collective utility of multi‑gene panels. The article reviews existing implementation studies, identifies gaps, and introduces the U‑PGx Consortium, funded by Horizon‑2020, to address the unmet need for evidence on multi‑gene PGx panel implementation. The U‑PGx Consortium will conduct a prospective, block‑randomized, controlled PREPARE study, pre‑emptively genotyping a guideline‑supported PGx panel across seven European countries, evaluating patient outcomes and cost‑effectiveness, and leveraging a unique multicenter, multigene, multidrug, multi‑ethnic, multi‑healthcare system design. Several implementation studies and programs have already been initiated in recent years.
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.
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