Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
Department of Orthopaedic Surgery, Oklahoma State University Medical Center, Tulsa, OK, USA.
J Osteopath Med. 2023 Aug 15;124(1):5-11. doi: 10.1515/jom-2023-0028. eCollection 2024 Jan 1.
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.
This study aims to explore the reasons for termination of clinical trials investigating OA during the COVID-19 pandemic.
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.
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.
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.
COVID-19 大流行扰乱了许多医学和外科领域的临床研究，导致研究浪费和患者治疗延误。尽管已经探索了其他领域，但目前尚不清楚大流行对骨关节炎（OA）试验的影响程度。
本研究旨在探讨 COVID-19 大流行期间终止 OA 临床试验的原因。
我们在 ClinicalTrials.gov 上搜索了 OA 试验，并对其终止原因进行了特征描述，注意试验者是否直接将 COVID-19 大流行作为试验终止的原因。我们还对其他常见的试验终止原因进行了编码。采用描述性和推断性统计方法，确定了因大流行和非大流行原因而提前终止的试验在入组、资金来源、试验阶段、分配和干预类型方面的差异。
在 135 项临床试验中，有 119 项符合纳入标准，其中 27 项（22.7%）报告 COVID-19 大流行是终止的主要原因，这是研究期间 OA 试验终止的总体最常见原因。我们发现，因大流行而终止的试验与因非大流行相关原因而终止的试验之间存在统计学显著差异，受影响最大的是试验地点在美国境外、随机分配和药物或器械干预类型。然而，两组在试验阶段、资金来源或入组方面没有统计学上的显著差异。
本研究强调了 COVID-19 大流行对 OA 相关临床试验的影响。我们发现，许多试验直接因大流行而报告终止，这可能导致 OA 新疗法的损失或延迟。为了避免未来出现这种终止，应该探索和实施替代方法来进行 OA 相关的临床试验。
