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Harvey C, Woodcock A, Vestbo J, et al. Safety data in randomised real-world evidence studies: Salford Lung Study learnings. ERJ Open Res. 2021;7(2)doi: 10.1183/23120541.00966-2020.
Harvey, C., Woodcock, A., Vestbo, J., Crim, C., Frith, L., Bakerly, N. D., New, J. P., Williams, C., Elkhenini, H., Majeed, N., Cardwell, G., Collier, S., Jacques, L., & Fletcher, J. (2021). Safety data in randomised real-world evidence studies: Salford Lung Study learnings. ERJ open research, 7(2), . https://doi.org/10.1183/23120541.00966-2020
Harvey, Catherine, et al. "Safety data in randomised real-world evidence studies: Salford Lung Study learnings." ERJ open research vol. 7,2 (2021). doi: https://doi.org/10.1183/23120541.00966-2020
Harvey C, Woodcock A, Vestbo J, Crim C, Frith L, Bakerly ND, New JP, Williams C, Elkhenini H, Majeed N, Cardwell G, Collier S, Jacques L, Fletcher J. Safety data in randomised real-world evidence studies: Salford Lung Study learnings. ERJ Open Res. 2021 May 31;7(2). doi: 10.1183/23120541.00966-2020. eCollection 2021 Apr. PMID: 34084785; PMCID: PMC8165374.
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ERJ Open Res. 2021 May 31;7(2). doi: 10.1183/23120541.00966-2020. eCollection 2021 Apr.

Safety data in randomised real-world evidence studies: Salford Lung Study learnings.

ERJ open research

Catherine Harvey, Ashley Woodcock, Jørgen Vestbo, Courtney Crim, Lucy Frith, Nawar Diar Bakerly, John P New, Claire Williams, Hanaa Elkhenini, Nasir Majeed, Glenn Cardwell, Susan Collier, Loretta Jacques, Joanne Fletcher

Affiliations

  1. GlaxoSmithKline plc, Uxbridge, Middlesex, UK.
  2. Manchester Academic Health Sciences Centre, The University of Manchester, Manchester, UK.
  3. Manchester University NHS Foundation Trust, Manchester, UK.
  4. GlaxoSmithKline plc, Research Triangle Park, NC, USA.
  5. Salford Royal NHS Foundation Trust, Salford, UK.
  6. NorthWest EHealth, Manchester, UK.
  7. Pennine Acute Hospitals NHS Trust, Oldham, UK.

PMID: 34084785 PMCID: PMC8165374 DOI: 10.1183/23120541.00966-2020

Abstract

Evidence to support clinical decision making must be based on safety data that have been captured, analysed and interpreted in a robust and reliable way. Randomised real-world evidence (RRWE) studies provide the opportunity to evaluate the use of medicines in patients and settings representative of routine clinical practice. However, elements that underpin the design of RRWE studies can have a significant impact upon the analysis, interpretation and implications of safety data. In this narrative review, we use data from the Salford Lung Study; two prospective, 12-month, open-label, parallel-group, phase III randomised controlled trials conducted in primary care in the UK; to highlight the importance of capturing treatment modifications when attempting to evaluate safety events according to actual treatment exposure. We demonstrate that analysing safety data by actual treatment received (

Copyright ©The authors 2021.

Conflict of interest statement

Conflict of interest: C. Harvey reports this study was funded by GlaxoSmithKline and medical writing support by Ashfield MedComms was also funded by GlaxoSmithKline; and she is an employee of and hold

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