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Pragmatic randomised controlled trials in COPD and asthma: how to guide clinical practice

Lookup NU author(s): Professor Anthony De SoyzaORCiD

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Abstract

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. The use of real-world evidence (RWE) studies, including pragmatic randomised controlled trials (RCTs; randomised RWE studies), to aid the development of treatment guidelines, is gradually becoming a mainstay within clinical practice. RWE is an integral part of patient-driven decision-making and offers important value to add complimentary evidence to traditional RCTs; these provide a more well-rounded view of the benefits to patient-reported outcomes and improve the external validity of a given treatment versus findings from traditional RCTs alone. Discussions in recent scientific workshops explored the importance of pragmatic RCTs in optimising guideline development and patient care in chronic obstructive pulmonary disease (COPD) and asthma. The Salford Lung Study in patients with COPD (NCT01551758) and asthma (NCT01706198) were the world's first prelicence pragmatic RCTs that compared novel investigational treatments with existing COPD and asthma treatments and, more recently (2021), RWE studies have been used by the American Thoracic Society and the US Food and Drug Administration to support the approval of an immunosuppressant drug in patients receiving lung transplants. This highlights the importance of RWE data in supporting clinical guideline development and emphasises the advantages for the use of pragmatic RCTs in guiding clinical practice.

Publication metadata

Author(s): Bakerly ND, Nikitin K, Snowise NG, Cardwell G, Freeman D, Saggu R, De Soyza A

Publication type: Article

Publication status: Published

Journal: BMJ Open Respiratory Research

Year: 2022

Volume: 9

Issue: 1

Online publication date: 30/09/2022

Acceptance date: 27/08/2022

Date deposited: 26/10/2022

ISSN (electronic): 2052-4439

Publisher: BMJ Publishing Group Ltd

URL: https://doi.org/10.1136/bmjresp-2022-001303

DOI: 10.1136/bmjresp-2022-001303

PubMed id: 36180103

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