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Delayed discovery: the COVID-19 pandemic's influence on osteoarthritis clinical trials
Nicholas B Sajjadi1, Jon Michael Anderson2, Griffin K Hughes1,3
1Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
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-pandemic-related 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.
Insights
The COVID-19 pandemic significantly impacted osteoarthritis (OA) clinical trials, with 22.7% terminating due to the pandemic. This disruption may delay new OA treatments, necessitating alternative trial strategies.
Area of Science:
- Clinical research
- Rheumatology
- Epidemiology
Background:
- The COVID-19 pandemic disrupted numerous medical and surgical clinical research fields.
- The pandemic's specific impact on osteoarthritis (OA) clinical trials remains largely unexplored.
- Research waste and treatment delays were consequences of pandemic-related disruptions.
Purpose of the Study:
- To investigate the reasons behind the termination of clinical trials focused on osteoarthritis (OA) during the COVID-19 pandemic.
- To quantify the extent to which the pandemic directly caused OA trial discontinuation.
Main Methods:
- Searched ClinicalTrials.gov for osteoarthritis (OA) trials.
- Characterized reasons for trial discontinuation, specifically noting pandemic-related causes.
- Utilized descriptive and inferential statistics to compare trials terminated due to pandemic versus non-pandemic reasons, analyzing enrollment, funding, phase, allocation, and intervention type.
Main Results:
- Out of 119 included OA trials, 27 (22.7%) cited the COVID-19 pandemic as the primary discontinuation reason, making it the most common cause.
- Trials with international sites, randomized allocation, and drug/device interventions were significantly more affected by pandemic-related terminations.
- No significant differences were observed in trial phase, funding source, or enrollment between pandemic and non-pandemic terminated trials.
Conclusions:
- The COVID-19 pandemic substantially impacted OA clinical trials, leading to widespread discontinuation.
- Pandemic-induced trial terminations risk delaying or preventing novel osteoarthritis treatments.
- Exploring and implementing alternative methodologies for conducting OA clinical trials is crucial to mitigate future disruptions.
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