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The impact of COVID-19 on the clinical trial

Zhimin Chen1, Liran Chen2, Huafang Chen3

  • 1Ningbo Hospital of Traditional Chinese Medicine, Zhejiang, China.

Plos One
|May 11, 2021
PubMed

Insights

The coronavirus disease 2019 pandemic significantly disrupted drug clinical trials, causing protocol deviations and affecting participant follow-up. While remote methods aided trial progress, overall quality was compromised.

Area of Science:

  • Clinical Research
  • Epidemiology
  • Pharmaceutical Sciences

Background:

  • The coronavirus disease 2019 (COVID-19) pandemic presented unprecedented challenges to global healthcare systems.
  • Ongoing and upcoming drug clinical trials faced significant operational hurdles due to public health measures and resource reallocation.

Purpose of the Study:

  • To investigate the multifaceted impact of the COVID-19 pandemic on the execution of drug clinical trials.
  • To identify specific changes and challenges encountered in clinical trial implementation during the pandemic.

Main Methods:

  • Qualitative semi-structured interviews were conducted with clinical trial staff.
  • Clinical trial participants were surveyed using questionnaires to gather their experiences.

Main Results:

  • The pandemic necessitated a shift to online meetings and telemedicine for follow-ups.
  • Increased protocol deviations, participant loss to follow-up, and express drug delivery were observed.
  • Screening for COVID-19 added workload, and participants experienced heightened anxiety.

Conclusions:

  • The COVID-19 outbreak hindered clinical trial progress and diminished trial quality.
  • While remote strategies like online meetings and telemedicine partially mitigated delays, they could not fully preserve pre-pandemic quality standards.

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