title: Obtaining real-world evidence: the Salford Lung Study.
abstract: We need to assess clinical treatments in real-life settings outside of randomised controlled trials (RCTs). Pragmatic RCT (pRCT) data can supplement RCTs by providing effectiveness information to support healthcare decisions. Electronic health records can facilitate concurrent safety monitoring and data collection without direct patient contact for large randomised study populations in pRCTs. The Salford Lung Study is the world's first phase III pRCT in asthma and chronic obstructive pulmonary disease (COPD), which aims to randomise over 7000 patients. This paper describes the hurdles overcome and the enormous effort and resource required to establish this comparative effectiveness study of a prelicence intervention.
  HZC115151 ASTHMA STUDY CLINICALTRIALSGOV REGISTRATION: NCT01706198 COPD STUDY CLINICALTRIALSGOV REGISTRATION: NCT01551758.
authors.affiliation: Salford Royal NHS Foundation Trust, Salford, UK.
authors.forename: John P
authors.initials: JP
authors.lastname: New
authors.affiliation: Salford Royal NHS Foundation Trust, Salford, UK.
authors.forename: Nawar Diar
authors.initials: ND
authors.lastname: Bakerly
authors.affiliation: GlaxoSmithKline UK Ltd, Stockley Park West, Uxbridge, Middlesex, UK.
authors.forename: David
authors.initials: D
authors.lastname: Leather
authors.affiliation: Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.
authors.forename: Ashley
authors.initials: A
authors.lastname: Woodcock
mesh_terms: D000280:Administration, Inhalation; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D017326:Clinical Trials, Phase III as Topic / Q000379:methods; D004338:Drug Combinations; D019317:Evidence-Based Medicine / Q000379:methods; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design
chemical_list: D000318:Adrenergic beta-Agonists; D004338:Drug Combinations; D005938:Glucocorticoids
keywords: Asthma; COPD Exacerbations