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Research Article
Alexandre Biasi Cavalcanti
Hospital do Coração
Corresponding Author
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Background: Acute respiratory distress syndrome (ARDS) is one of the most challenging clinical conditions of the critical care medicine. Previous studies estimate the economic impact and the public return of the clinical trials on public health.
Methods: The ART was conducted through a multicenter randomized trial at 120 intensive care units (ICUs) from 9 countries from November , 2011, through April, 2017, enrolling adults with moderate-to-severe ARDS, which investigated whether lung recruitment associated with PEEP titration according to the best respiratory-system compliance decreases 28-day mortality of patients compared with a conventional low-PEEP strategy. This paper identifies the economic impact of the clinical trial from the value of lives saved if the trial findings were implemented in the eligible patient populations for one year, and then computes the public return by subtracting the relevant clinical trial costs from the gross benefit. The economic impact was computed by subtracting the ART costs from its gross benefit.
Results: The net benefit of the ART is approximately 152 millions of dollars if the ART findings is implemented in 50% of the eligible patients in Brazil, under the baseline assumptions. Moreover, for every dollar spent in the clinical trial, a return of 114 dollars was achieved in Brazil alone. If the ART’s trial findings were implemented in all eligible patients, then a return of the trial would be 229.5 dollars for every one dollar invested, and net benefit would be around 304 millions of dollars.
Conclusions: These findings highlight the substantial economic benefit of clinical trials on ARDS treatments for the society. It also points out that the public return of clinical trials can be potentialized when the new trials’ findings are fully implemented on eligible patients. Efforts should be made to integrate clinical trials findings with the frontline health care delivery.
Keywords
acute respiratory distress syndrome (ARDS), PEEP-based Lung Recruitment Clinical Trial Programme, frontline health care delivery, Coronavirus, COVID-19
Competing interest reported. ABC: Grants from Bactiguard, Ionis Pharmaceuticals, Brazilian Ministry of Health (PROADI-SUS), Brazilian Ministry of Science and Technology, Bayer, Pfizer, Hillrom, Fisher & Paykel, Baxter; VCV: Grants from Aspen, Pfizer.
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A new preprint design is coming!
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This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Research Article
Alexandre Biasi Cavalcanti
Hospital do Coração
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
History
CURRENT STATUS: Posted
Version 1
Posted 24 Feb, 2021
No community comments so far
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Pulmonology
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Acute respiratory distress syndrome (ARDS) is one of the most challenging clinical conditions of the critical care medicine. Previous studies estimate the economic impact and the public return of the clinical trials on public health.
Methods: The ART was conducted through a multicenter randomized trial at 120 intensive care units (ICUs) from 9 countries from November , 2011, through April, 2017, enrolling adults with moderate-to-severe ARDS, which investigated whether lung recruitment associated with PEEP titration according to the best respiratory-system compliance decreases 28-day mortality of patients compared with a conventional low-PEEP strategy. This paper identifies the economic impact of the clinical trial from the value of lives saved if the trial findings were implemented in the eligible patient populations for one year, and then computes the public return by subtracting the relevant clinical trial costs from the gross benefit. The economic impact was computed by subtracting the ART costs from its gross benefit.
Results: The net benefit of the ART is approximately 152 millions of dollars if the ART findings is implemented in 50% of the eligible patients in Brazil, under the baseline assumptions. Moreover, for every dollar spent in the clinical trial, a return of 114 dollars was achieved in Brazil alone. If the ART’s trial findings were implemented in all eligible patients, then a return of the trial would be 229.5 dollars for every one dollar invested, and net benefit would be around 304 millions of dollars.
Conclusions: These findings highlight the substantial economic benefit of clinical trials on ARDS treatments for the society. It also points out that the public return of clinical trials can be potentialized when the new trials’ findings are fully implemented on eligible patients. Efforts should be made to integrate clinical trials findings with the frontline health care delivery.
Competing interest reported. ABC: Grants from Bactiguard, Ionis Pharmaceuticals, Brazilian Ministry of Health (PROADI-SUS), Brazilian Ministry of Science and Technology, Bayer, Pfizer, Hillrom, Fisher & Paykel, Baxter; VCV: Grants from Aspen, Pfizer.
This is a list of supplementary files associated with this preprint. Click to download.
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