Extract
Properly designed and conducted randomised controlled trials (RCTs) represent the gold standard study type for conclusively evaluating any efficacy, effectiveness and/or safety of healthcare interventions. However, they are frequently associated with risks and burden to patients and require extensive resources [1]. These can only be considered acceptable if the RCTs fulfil their main objective, that is, to inform guidelines and clinical practice, and ultimately improve patients’ health. Regrettably, RCTs are often less informative than they could be, owing to deficiencies in their design, and this may sometimes contribute to “research waste” [2, 3]. This needs to be remedied by strengthening and harmonising trial methods, delivery and reporting. This has implications across the breadth of clinical medicine.
Abstract
#RCTs in #Respiratory medicine require harmonisation. A core outcome set #COS is an agreed minimum set of outcomes that are critical for decision-making and should be evaluated in all future clinical trials. https://bit.ly/3XQmbtH
Footnotes
Disclaimer: Content of this publication reflects only the author's view, and the Innovative Medicines Initiative 2 Joint Undertaking (JU) and the European Respiratory Society (ERS) are not responsible for any use that may be made of the information it contains. In particular, authors who hold office in the ERS are writing in their personal, not official, capacity.
Author contributions: Conception: A.G. Mathioudakis, E. Khaleva, M. Fally, G. Roberts and J. Vestbo. Drafting the manuscript: A.G. Mathioudakis, E. Khaleva and M. Fally. Critical revision of the manuscript: All authors.
Conflicts of interest: A.G. Mathioudakis, M. Fally, J-U. Jensen, T.W. Felton, A. Bush, J. Linnell, T. Welte and J. Vestbo report no conflicts of interest. E. Khaleva and C. Coleman report funding from the EU (3TR IMI) related to this work. C. Coleman is an employee of the European Lung Foundation. P.R. Williamson reports consulting fees from the European Respiratory Society for the development of the COS-AECOPD. C. Brightling reports funding from the EU (3TR IMI) related to this work; and also reports grants and consulting fees from AstraZeneca, GlaxoSmithKline, Roche, Genentech, Chiesi, Sanofi, Regeneron, Mologic, Novartis and 4Dpharma, not related to this work. T. Winders reports honoraria, support for attending meetings and participation on advisory boards for AstraZeneca, Amgen, ALK Abello, Sanofi, Regeneron, Novartis and Merck, not related to this work. V. Ramiconi reports grants from Novartis, Pfizer, AstraZeneca, Chiesi, GlaxoSmithKline, AbbVie, LeoPharma, Boehringer Ingelheim, Sanofi, Regeneron, OM Pharma, MSD, Roche and DBV Technologies, and support for attending meetings from Novartis, not related to this work. G. Roberts reports funding from the EU (3TR IMI) related to this work; and also reports a leadership role in the British Society of Allergy and Clinical Immunology (President), not related to this work.
Support statement: A.G. Mathioudakis, T.W. Felton and J. Vestbo are supported by the National Institute for Health and Care Research Manchester Biomedical Research Centre (NIHR Manchester BRC). A.G. Mathioudakis is supported by an NIHR Clinical Lectureship in Respiratory Medicine. The 3TR COMSA project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 831434 (3TR). The JU receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA. Funding information for this article has been deposited with the Crossref Funder Registry.
- Received November 1, 2022.
- Accepted January 16, 2023.
- Copyright ©The authors 2023. For reproduction rights and permissions contact permissions{at}ersnet.org