Document Type
Article
Publication Title
Journal of Osteopathic Medicine
Abstract
Context: The COVID-19 pandemic disrupted clinical research in many medical and surgical fields, resulting in research waste and loss of treatment for patients. Although other areas have been explored, the extent of the pandemic’s influence on osteoarthritis (OA) trials is currently unknown.
Objectives: This study aims to explore the reasons for termination of clinical trials investigating OA during the COVID-19 pandemic.
Methods: We searched ClinicalTrials.gov for OA trials and characterized their reason for discontinuation, noting where trialists directly cited the COVID-19 pandemic as the reason for trial discontinuation. We also coded other common reasons for trial discontinuation. Descriptive and inferential statistics were performed to determine the difference in enrollment, funding source, trial phase, allocation, and intervention type between the trials terminated early due to pandemic and nonpandemic reasons.
Results: Out of 135 clinical trials, 119 were included and 27 (22.7 %) of them reported the COVID-19 pandemic as a primary reason for discontinuation, which was the overall most common reason for OA trial discontinuation during the study period. We found statistically significant differences for trials discontinued due to pandemic vs. non–pandemicrelated reasons, with trials having sites outside the United States, randomized allocation, and drug or device intervention type being most affected. However, there was no statistically significant difference between groups regarding trial phase, funding source, or enrollment.
Conclusions: This study highlights the impact of the COVID-19 pandemic on the clinical trials related to OA. We found that many trials reported discontinuation directly due to the pandemic, which may lead to the loss or delay of novel treatments for OA. To avoid such discontinuation in the future, alternative methods for conducting OA-related clinical trials should be explored and implemented.
DOI
10.1515/jom-2023-0028
Publication Date
8-15-2023
Keywords
clinical trials, COVID-19, orthopedics, osteoarthritis
ISSN
2702-3648
Recommended Citation
Sajjadi NB, Anderson J, Hughes GK, Abraham C, Malik J, Hartwell M, Vassar M. Delayed Discovery: The COVID-19 Pandemic’s Influence on Osteoarthritis Clinical Trials. Journal of Osteopathic Medicine. 2023; . doi: 10.1515/jom-2023-0028.
