Designing and incorporating a real world data approach to international drug development and use: what the UK offers. Issue 3 (March 2016)

• Record Type: Journal Article
• Authors: Bate, Andrew; Juniper, Jane; Lawton, Andy M.; Thwaites, Rob M.A.
• Is Part Of: Drug discovery today. Volume 21:Issue 3(2016)
• Page Start: 400
• Page End: 405
• Publication Date: 2016-03
• Subjects: Drugs -- Design -- Periodicals; Drugs -- Research -- Periodicals; 615.1
• DOI: 10.1016/j.drudis.2015.12.002
• Languages: English
• ISSNs: 1359-6446

Abstract

Highlights: The RWD approach to problem solving uses routinely collected healthcare data as a cost-effective strategy for clinical research. The RWD approach is applicable across a wide range of clinical research topics. The UK healthcare system is suited to the RWD approach. 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.