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. 2024 Oct 12;25(1):673.
doi: 10.1186/s13063-024-08547-2.

Why were so few randomized trials of public health and social measures conducted during the COVID-19 pandemic? The Norwegian experience

Atle Fretheim  1 , Petter Elstrøm  2 , Cathinka Halle Julin  2 , Unni Gopinathan  2 , Ingeborg Hess Elgersma  2 , Runar Barstad Solberg  2 , Arnfinn Helleve  2   3
Affiliations

Why were so few randomized trials of public health and social measures conducted during the COVID-19 pandemic? The Norwegian experience

Atle Fretheim et al. Trials. .

Abstract

Background: Few randomized trials of public health and social measures were carried out during the COVID-19 pandemic. We report on the major barriers we faced when we tried to run such trials.

Methods: We reviewed all randomized trials proposed and initiated by the Centre for Epidemic Interventions Research in Norway during the COVID-19 pandemic.

Results: Of the 18 proposed trials, 11 trials were not implemented. One of the key legal and ethical barriers to conducting the trials was the Norwegian Health Research Act, which demands informed consent from all participants who are exposed to an intervention. A lack of sufficient political support was also a challenge, as was unpredictability, due to shifting disease incidence and changing recommendations from the authorities.

Conclusion: Strengthening the evidence base for public health and social measures in pandemics will require political and public understanding and support and a legal framework that allows for the conduct of such trials.

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Conflict of interest statement

All authors are involved in the planning and conduct of randomized trials of public health and social measures.

References

    1. Enria D, Feng Z, Fretheim A, Ihekweazu C, Ottersen T, Schuchat A, Ungchusak K, Briand S, Haldane V, Lamichhane J, et al. Strengthening the evidence base for decisions on public health and social measures. Bull World Health Organ. 2021;99(9):610-610A. 10.2471/BLT.21.287054. - DOI - PMC - PubMed
    1. Glasziou PP, Michie S, Fretheim A. Public health measures for covid-19. BMJ. 2021;375:n2729. 10.1136/bmj.n2729. - DOI - PubMed
    1. Glasziou P, Sanders S, Byambasuren O, Thomas R, Hoffmann T, Greenwood H, van der Merwe M, Clark J. Clinical trials and their impact on policy during COVID-19: a review. Wellcome Open Res. 2024;9:20. 10.12688/wellcomeopenres.19305.1. - DOI - PMC - PubMed
    1. Jefferson T, Dooley L, Ferroni E, Al-Ansary LA, van Driel ML, Bawazeer GA, Jones MA, Hoffmann TC, Clark J, Beller EM, et al. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2023;1(1):CD006207. 10.1002/14651858.CD006207.pub6. - DOI - PMC - PubMed
    1. Fretheim A, Elgersma IH, Kristiansen FA, Varmbo CR, Olsbo MKS, Glover IHS, Flato M. The effectiveness of free face mask distribution on use of face masks. A cluster randomised trial in Stovner District of Oslo, Norway. Int J Environ Res Public Health. 2021;18(17):8971. 10.3390/ijerph18178971. - DOI - PMC - PubMed

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