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Audit, research and guideline update
Obtaining real-world evidence: the Salford Lung Study
  1. John P New1,
  2. Nawar Diar Bakerly1,
  3. David Leather2,
  4. Ashley Woodcock3
  1. 1Salford Royal NHS Foundation Trust, Salford, UK
  2. 2GlaxoSmithKline UK Ltd, Stockley Park West, Uxbridge, Middlesex, UK
  3. 3Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK
  1. Correspondence to Professor Ashley Woodcock, Institute of Inflammation and Repair, 2nd Floor Education and Research Centre, University Hospital of South Manchester NHS Foundation Trust, Southmoor Road, Manchester M23 9LT, UK; ashley.woodcock{at}manchester.ac.uk

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.

GlaxoSmithKline protocol HZC115151

Asthma study clinicaltrials.gov registration NCT01706198

COPD study clinicaltrials.gov registration NCT01551758

  • Asthma
  • COPD Exacerbations

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