The impact of COVID-19 on the clinical trial

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

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.

MeSH terms

  • Adult
  • Antiviral Agents / therapeutic use
  • Anxiety / etiology
  • COVID-19 / epidemiology
  • COVID-19 / pathology*
  • COVID-19 / virology
  • COVID-19 Drug Treatment
  • Clinical Trials as Topic*
  • Humans
  • Interviews as Topic
  • Middle Aged
  • Pandemics
  • Patients / psychology
  • Research Personnel / psychology
  • SARS-CoV-2 / isolation & purification
  • Surveys and Questionnaires
  • Telemedicine
  • Young Adult

Substances

  • Antiviral Agents

Grants and funding

Tang Wealth Investment Management Co. Ltd provided support in the form of salaries for IC. The specific roles of these authors are articulated in the ‘author contributions’ section. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.