Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Dec 3;80(1):245.
doi: 10.1186/s13690-022-00999-9.

Implementing an outpatient clinical trial on COVID-19 treatment in an emergency epidemic context: a mixed methods study among operational and research stakeholders within the Coverage trial, Bordeaux (France)

Carine Grenier #  1   2   3 , Macha Loniewski #  1   2   3 , Mélanie Plazy  1   2   3 , Racha Onaisi  4 , Marie-Hélène Doucet  1   2   3 , Jean-Philippe Joseph  4 , Alexandre Duvignaud  1   2   3   5 , Denis Malvy  1   2   3   5 , Xavier Anglaret  1   2   3 , Joanna Orne-Gliemann  6   7   8 ; Coverage study group
Affiliations

Implementing an outpatient clinical trial on COVID-19 treatment in an emergency epidemic context: a mixed methods study among operational and research stakeholders within the Coverage trial, Bordeaux (France)

Carine Grenier et al. Arch Public Health. .

Abstract

Background: The emergency set-up and implementation of outpatient clinical trials on epidemic emerging infectious diseases such as COVID-19 raise many issues in terms of research structuration, regulations, and health systems organization. We aimed to describe the experience and points of view of different stakeholders involved in a French home-based outpatient trial on COVID-19 and to identify the early barriers and facilitators to the trial implementation.

Methods: We conducted a mixed-methods study in July 2020. A self-administered questionnaire was emailed to 213 clinical, operational and research stakeholders involved in the Coverage trial; individual semi-directed interviews were conducted among 14 stakeholders. Questionnaire data and written interview notes are presented together by key theme.

Results: One hundred fifty six stakeholders responded to the questionnaire. 53.4% did not have prior experience in clinical research. The motivation of most stakeholders to participate in the Coverage trial was to feel useful during the pandemic. 87.9% agreed that the trial had an unusual set-up timeframe, and many regretted a certain lack of regulatory flexibility. Mobile medical teams and specific professional skills were perceived as instrumental for outpatient research.

Conclusions: The implementation of a home-based outpatient clinical trial on COVID-19 was perceived as relevant and innovative although requiring important adaptations of usual professional responsibilities and standard research procedures. Lessons learned from the Coverage trial underline the need for improved networks between hospital and community medicine, and call for a dedicated and reactive outpatient research platform on emerging or threatening infectious diseases.

Keywords: Ambulatory; Covid; Implementation; Perceptions; Treatment.

PubMed Disclaimer

Conflict of interest statement

Not applicable.

Figures

Fig. 1
Fig. 1
Overall perception of the Coverage trial implementation. (n: number of respondents to the question, i.e. excludes missing responses). a Early perceptions of the trial. b Perceptions of the operational implementation of the trial
Fig. 2
Fig. 2
Perceptions of outpatient trials and of the Coverage trial contribution. a Perceptions of outpatient trials compared to hospital-based trials. b Perceptions on the contribution of the Coverage trial
See this image and copyright information in PMC

References

    1. Clinical Trials.gov. ClinicalTrials - Search. https://clinicaltrials.gov/ct2/home cited 2021 Nov 18
    1. Dillman A, Zoratti MJ, Park JJH, Hsu G, Dron L, Smith G, et al. The Landscape of Emerging Randomized Clinical Trial Evidence for COVID-19 Disease Stages: A Systematic Review of Global Trial Registries. Infect Drug Resist. 2020;22(13):4577–4587. doi: 10.2147/IDR.S288399. - DOI - PMC - PubMed
    1. Join the PRINCIPLE Trial — PRINCIPLE Trial. Available from: https://www.principletrial.org cited 2022 Feb 18
    1. Hajjar F, Saint-Lary O, Cadwallader J-S, Chauvin P, Boutet A, Steinecker M, et al. Development of Primary Care Research in North America, Europe, and Australia From 1974 to 2017. Ann Fam Med. 2019;17(1):49–51. doi: 10.1370/afm.2328. - DOI - PMC - PubMed
    1. Glanville J, Kendrick T, McNally R, Campbell J, Hobbs FDR. Research output on primary care in Australia, Canada, Germany, the Netherlands, the United Kingdom, and the United States: bibliometric analysis. BMJ. 2011;8(342):d1028. doi: 10.1136/bmj.d1028. - DOI - PMC - PubMed

LinkOut - more resources