Delayed discovery: the COVID-19 pandemic's influence on osteoarthritis clinical trials.

IF 1.4 Q2 MEDICINE, GENERAL & INTERNAL Journal of Osteopathic Medicine Pub Date : 2023-08-15 eCollection Date: 2024-01-01 DOI:10.1515/jom-2023-0028
Nicholas B Sajjadi, Jon Michael Anderson, Griffin K Hughes, Christena E Abraham, Jamal Malik, Micah Hartwell, Matt Vassar
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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-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.

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延迟发现:COVID-19 大流行对骨关节炎临床试验的影响。
背景:COVID-19 大流行扰乱了许多医学和外科领域的临床研究,造成了研究浪费和患者治疗损失。虽然对其他领域进行了探讨,但目前尚不清楚大流行对骨关节炎(OA)试验的影响程度:本研究旨在探讨在 COVID-19 大流行期间终止研究 OA 的临床试验的原因:我们搜索了ClinicalTrials.gov上的OA试验,并对其终止原因进行了描述,同时注意到试验者直接将COVID-19大流行作为试验终止原因的情况。我们还对其他常见的试验终止原因进行了编码。我们进行了描述性和推论性统计,以确定因大流行和非大流行原因而提前终止的试验在注册人数、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,纳入了 119 项,其中 27 项(22.7%)报告 COVID-19 大流行是试验终止的主要原因,这也是研究期间 OA 试验终止的最常见原因。我们发现,因大流行而中止的试验与非大流行相关原因中止的试验在统计学上存在显著差异,其中受影响最大的是试验地点在美国境外、随机分配以及药物或器械干预类型的试验。然而,在试验阶段、资金来源或注册人数方面,各组之间没有明显的统计学差异: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终止,这可能导致OA新疗法的丧失或延迟。为避免今后出现此类试验中止的情况,应探索并实施其他方法来开展与 OA 相关的临床试验。
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来源期刊
Journal of Osteopathic Medicine
Journal of Osteopathic Medicine Health Professions-Complementary and Manual Therapy
CiteScore
2.20
自引率
13.30%
发文量
118
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