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Accepted for/Published in: JMIR Perioperative Medicine

Date Submitted: Nov 12, 2021
Date Accepted: Mar 30, 2022
Date Submitted to PubMed: Mar 31, 2022

The final, peer-reviewed published version of this preprint can be found here:

Influence of the COVID-19 Pandemic on Clinical Trial Discontinuation in Anesthesiology: Cross-sectional Analysis

Traxler BD, Rucker BM, Greenough MC, Sajjadi NB, Hartwell M

Influence of the COVID-19 Pandemic on Clinical Trial Discontinuation in Anesthesiology: Cross-sectional Analysis

JMIR Perioper Med 2022;5(1):e34936

DOI: 10.2196/34936

PMID: 35358057

PMCID: 8985690

The Influence of COVID-19 on Clinical Trial Discontinuation in Anesthesiology: Cross-Sectional Analysis

  • Brett D Traxler; 
  • Brayden M Rucker; 
  • Mary C Greenough; 
  • Nicholas B Sajjadi; 
  • Micah Hartwell

ABSTRACT

Background:

The COVID-19 pandemic has significantly altered perioperative care due to lockdown policies, supply chain shortages, and resource reallocation. While the impact of the pandemic on Anesthesiology care has been studied, the extent of influence on registered anesthesiology clinical trials is unknown.

Objective:

The primary objective was to evaluate the extent of clinical trial disruption in the field of anesthesiology secondary to the COVID-19 pandemic.

Methods:

We generated a systematic search on October 2, 2021 using ClinicalTrials.gov to identify clinical trials related to the practice of anesthesiology. To receive all trials potentially affected by the COVID-19 pandemic, our date range was January 1, 2020 through October 1, 2021. Investigators screened for relevant studies and performed data extraction in duplicate. We calculated the rate of discontinuation explicitly due to COVID-19. We performed statistical tests to assess associations between trials discontinued due to COVID-19 and various trial parameters.

Results:

A total of 823 clinical trials met inclusion criteria, and 146 clinical trials were discontinued within the designated date range. Twenty-four (16.4%) of the 146 clinical trials were halted explicitly due to the COVID-19 pandemic. A significant association existed between trial enrollment numbers and the likelihood of discontinuation due to COVID-19, as larger trials were more likely to be disrupted ( z= -2.914, P=.0036).

Conclusions:

The COVID-19 pandemic has been a major cause of anesthesiology-related clinical trial discontinuation. With the uncertain course of the COVID-19 pandemic, we recommend that future trials examine alternative methods for trial protocols to help minimize social interaction and prevent premature trial disruption.


 Citation

Please cite as:

Traxler BD, Rucker BM, Greenough MC, Sajjadi NB, Hartwell M

Influence of the COVID-19 Pandemic on Clinical Trial Discontinuation in Anesthesiology: Cross-sectional Analysis

JMIR Perioper Med 2022;5(1):e34936

DOI: 10.2196/34936

PMID: 35358057

PMCID: 8985690

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