title: Designing and incorporating a real world data approach to international drug development and use: what the UK offers.
abstract: Assessments of the safety, efficacy and appropriate use of new medicines lie at the heart of treatment development and subsequent adoption in clinical practice. Highly controlled randomised clinical trials routinely inform decisions on the approval, coverage and use of a medicine. Researchers and decision makers have become increasingly aware that these experimental data alone are insufficient to address those decisions fully. Real world data recorded from routine healthcare delivery by healthcare professionals and patients help provide a more complete picture of care. The UK, with its connectivity and rich longitudinal patient records, accumulated research and informatics experience and National Health Service, provides an exemplar of how real world data address a wide range of challenges across drug development.
authors.affiliation: Epidemiology Group Lead, Analytics, Worldwide Safety, Pfizer, UK; Department of Clinical Pharmacology, New York University (NYU), USA. Electronic address: andrew.bate@pfizer.com.
authors.forename: Andrew
authors.initials: A
authors.lastname: Bate
authors.affiliation: Pharmonyze Limited, UK; West of England Academic Health Science Network, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Juniper
authors.affiliation: GlaxoSmithKline R&D Ltd, UK.
authors.forename: Andy M
authors.initials: AM
authors.lastname: Lawton
authors.affiliation: Takeda Development Centre Europe, UK.
authors.forename: Rob M A
authors.initials: RM
authors.lastname: Thwaites
mesh_terms: D003625:Data Collection; D055808:Drug Discovery; D006291:Health Policy; D006801:Humans; D009369:Neoplasms / Q000175:diagnosis; D011565:Psoriasis / Q000150:complications; D051436:Renal Insufficiency, Chronic / Q000150:complications; D012107:Research Design; D006113:United Kingdom