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. 2021 May 11;16(5):e0251410.
doi: 10.1371/journal.pone.0251410. eCollection 2021.

The impact of COVID-19 on the clinical trial

Zhimin Chen  1 , Liran Chen  2 , Huafang Chen  3
Affiliations

The impact of COVID-19 on the clinical trial

Zhimin Chen et al. PLoS One. .

Abstract

The objective of this study was to explore the impact of the coronavirus disease 2019 epidemic on ongoing and upcoming drug clinical trials. Qualitative semi-structured interviews were conducted with clinical trial staff and clinical trial subjects were surveyed by questionnaire in this study. The results of interviews and questionnaire showed that coronavirus disease 2019 pandemic has led to many changes in the implementation of drug clinical trials, including: a variety of meetings being held online webinars using various platforms, telemedicine and follow-up by video, A large number of deviations from protocol and losses of follow-up, delivery of clinical trial drugs by express, additional workload caused by screening for coronavirus, and anxiety of subjects. These results suggest that the coronavirus disease 2019 outbreak has hindered the progress and damaged the quality of clinical trials. The online meeting, remote follow-up, express delivery of drugs and remote monitoring in the epidemic environment can ensure the progress of clinical trials to a certain extent, but they cannot fully guarantee the quality as before.

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Conflict of interest statement

The authors have read the journal’s policy and have the following competing interests: IC is a paid employee of Tang Wealth Investment Management Co. Ltd. There are no patents, products in development or marketed products associated with this research to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

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