The Impact of COVID-19 on Otolaryngology Research: A Cross-Sectional Analysis of Discontinued Trials

Background: 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. The primary objective was to examine the extent of clinical trial disruption secondary to the COVID-19 pandemic in the field of otolaryngology.

Methods: On August 1, 2021, we conducted a systematic search using ClinicalTrials.gov for clinical trials related to common otolaryngology disorders. We used 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: 1,777 clinical trials met inclusion criteria, and 223 clinical trials were discontinued between January 1, 2020, and August 1, 2021. Thirty-three (14.8%) of the 223 clinical trials 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 Of the 33 clinical trials, 19 (57.6%) were suspended, 9 (27.3%) were terminated, and 5 (15.2%) were withdrawn.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 (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 < .001). There were no significant associations between trial location, funding source, randomization, or whether a study involved masked versus unmasked participants.

Conclusions: The COVID-19 pandemic has incited a profound impact on clinical research in the field of otolaryngology. To preserve trial continuation amidst future threats to participant interaction and communication, we recommend further exploration of remote monitoring practices and virtual procedures- those of which 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.