ABSTRACT
BACKGROUND: The COVID-19 pandemic drastically altered perioperative medical practice owing to safety concerns, postponing elective or nonemergent procedures, supply chain shortages, and reallocating perioperative staff to care for patients with COVID-19. However, the impact of the pandemic on the conduct on anesthesiology clinical research is unknown. OBJECTIVE: The primary objective was to quantify the magnitude of the COVID-19 pandemic's impact on anesthesiology clinical research. METHODS: We performed a systematic search using ClinicalTrials.gov to identify clinical trials related to the practice of anesthesiology. We screened trials with status updates from January 1, 2020, through October 1, 2021, to capture trials potentially affected by the COVID-19 pandemic by the time of our search. Investigators screened for relevant studies and extracted trial characteristics along with the reason for discontinuation reported on the clinical trial registry. RESULTS: A total of 823 clinical trials met inclusion criteria, and 146 clinical trials were discontinued within the designated date range. In total, 24 (16.4%) of the 146 clinical trials were halted explicitly owing to the COVID-19 pandemic. A significant association existed between trial enrollment numbers and the likelihood of discontinuation due to the COVID-19 pandemic, as larger trials were more likely to be disrupted (z=-2.914, P=.004). CONCLUSIONS: The COVID-19 pandemic is reportedly associated with the discontinuation of anesthesiology-related clinical trials. With the uncertain course of the COVID-19 pandemic, developing anesthesia trial protocols to help minimize social interaction and prevent premature trial disruption are imperative.
ABSTRACT
CONTEXT: The COVID-19 pandemic has reduced the capacity to conduct medical research due to recruitment difficulties, supply chain shortages, and funding deficits. The clinical practice of otolaryngology was especially impacted due to a reduction in elective procedures, such as facial plastic surgeries and vocal fold injections. OBJECTIVES: The primary objective was to examine the extent of clinical trial (CTs) disruption secondary to the COVID-19 pandemic in the field of otolaryngology. METHODS: On August 1, 2021, we conducted a systematic search utilizing ClinicalTrials.gov for CTs related to common otolaryngology disorders. We utilized the date range January 1, 2020 through August 1, 2021 to identify all trials potentially affected by the COVID-19 pandemic. Investigators performed screening and data extraction in a duplicate, masked fashion. Trials resulting from the search were extracted for trial status, condition treated, enrollment number, funding, study type, study design, last update posted date, and trial location. Trials that explicitly mentioned COVID-19 as a reason for discontinuation or suspension were coded as such. For trials that did not explicitly mention COVID-19, we coded the reason provided from ClinicalTrials.gov. The Oklahoma State University Center for Health Science Institutional Review Board determined that this project did not qualify as human subject research. RESULTS: A total of 1,777 CTs met the inclusion criteria, and 223 CTs were discontinued between January 1, 2020 and August 1, 2021. Thirty-three (14.8%) of the 223 CTs reported discontinuation explicitly due to the COVID-19 pandemic. The 33 studies had 1,715 participants enrolled in total. Among the primary interventions, 11 (33.3%) were devices, 10 (30.3%) were drugs, 5 (15.2%) were behavioral, 4 (12.1%) were diagnostic tests, 1 (3.0%) was dietary, and 2 (6.1%) were labeled as "other." Regarding the CT location, 20 (60.6%) were conducted in the United States, and 13 (39.4%) were conducted internationally. Of the 33 CTs, 19 (57.6%) were suspended, 9 (27.3%) were terminated, and 5 (15.2%) were withdrawn. The overall most common reason for trial disruption was recruitment difficulties (24.2%). Median enrollment for discontinued trials due to COVID-19 was 37 (interquartile range [IQR], 19-71) and for other reasons was 6 (IQR, 0-27), for which the Mann-Whitney test showed a statistically significant difference between the two (z=-3.913, p<0.001). There were no significant associations between trial location, funding source, randomization, or whether a study involved masked vs unmasked participants. CONCLUSIONS: The COVID-19 pandemic has incited an impact on clinical research in the field of otolaryngology. To preserve trial continuation amid future threats to participant interaction and communication, we recommend further exploration of remote monitoring practices and virtual procedures-those that will maintain the effectiveness and accuracy needed to establish novel therapeutics. We encourage future trials to gauge which remote assessments show the greatest validity, with the long-term goal of establishing innovative study designs resilient to future pandemics.