title: An evaluation of regulatory and commercial barriers to stratified medicine development and adoption.
abstract: Today, a range of products based on genomics, proteomics and metabolomics have facilitated the development of 'stratified' medicines and companion diagnostics. This investigation profiles a series of targeted medicines and corresponding diagnostics, and their role(s) in supporting evidence-based medicine. Despite their potential benefits we found that scientific, financial and regulatory barriers impede the development and adoption of companion diagnostics. Therefore, in order to realise improvements to the risk/benefit profiles of health-care interventions-notably reducing clinical uncertainty-conferred by the use of companion diagnostics, industry representatives, health-care providers and regulators will need a coordinated response to overcome these barriers.
authors.affiliation: Kinapse, Wimbledon, London, UK.
authors.forename: N A
authors.initials: NA
authors.lastname: Meadows
authors.affiliation: Amgen, Cambridge, UK.
authors.forename: A
authors.initials: A
authors.lastname: Morrison
authors.affiliation: 1] Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK [2] Harvard Stem Cell Institute, Holyoke Centre, Cambridge, MA, USA [3] UCL Centre for Behavioural Medicine, UCL School of Pharmacy, BMA House, London, UK [4] Oxford-UCL Centre for the Advancement of Sustainable Medical Innovation, University of Oxford, Oxford, UK and University College London, London, UK.
authors.forename: D A
authors.initials: DA
authors.lastname: Brindley
authors.affiliation: Oxford National Institute of Health Research (NIHR), Biomedical Research Centre (BRC), Molecular Diagnostic Centre (MDC), Oxford University Hospitals, Oxford, UK.
authors.forename: A
authors.initials: A
authors.lastname: Schuh
authors.affiliation: Oxford-UCL Centre for the Advancement of Sustainable Medical Innovation, University of Oxford, Oxford, UK and University College London, London, UK.
authors.forename: R W
authors.initials: RW
authors.lastname: Barker
mesh_terms: D017326:Clinical Trials, Phase III as Topic / Q000331:legislation & jurisprudence / Q000592:standards; D055808:Drug Discovery / Q000331:legislation & jurisprudence* / Q000592:standards*; D004345:Drug Industry / Q000331:legislation & jurisprudence* / Q000592:standards*; D006801:Humans; D057285:Precision Medicine / Q000592:standards