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. 2022 Nov 8;23(1):927.
doi: 10.1186/s13063-022-06804-w.

Conducting a supportive oncology clinical trial during the COVID-19 pandemic: challenges and strategies

Jie Deng  1 , John N Lukens  2 , Joy C Cohn  2 , Erin McMenamin  2 , Barbara Murphy  3 , Bryan A Spinelli  4 , Niya Murphy  2 , Alicia K Steinmetz  2 , Megan A Landriau  2 , Alexander Lin  2
Affiliations

Conducting a supportive oncology clinical trial during the COVID-19 pandemic: challenges and strategies

Jie Deng et al. Trials. .

Abstract

The coronavirus disease 2019 (COVID-19) pandemic resulted in severe interruptions to clinical research worldwide. This global public health crisis required investigators and researchers to rapidly develop and implement new strategies and solutions to mitigate its negative impact on the progress of clinical trials. In this paper, we describe the challenges, strategies, and lessons learned regarding the continuation of a supportive oncology clinical trial during the pandemic. We hope to provide insight into the implementation of clinical trials during a public health emergency to be better prepared for future instances.Trial registration: ClinicalTrials.gov, a service of the US National Institute of Health (NCT03030859). Registered on 22 January 2017.

Keywords: COVID-19; Clinical trials; Fibrosis; Head and neck cancer; Lymphedema; Pandemic; Participant safety; Telehealth; Trial operation; Virtual visits.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Standard Protocol Items: Recommendation for Interventional Trials (SPIRIT) Figure
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