Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
Department of Otolaryngology - Head and Neck Surgery, Oklahoma State University Medical Center, Tulsa, OK, USA.
J Osteopath Med. 2022 Apr 1;122(8):393-399. doi: 10.1515/jom-2021-0278.
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 (CTs) disruption secondary to the COVID-19 pandemic in the field of otolaryngology.
On August 1, 2021, we conducted a systematic search utilizing ClinicalTrials.gov for CTs related to common otolaryngology disorders. We utilized 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.
A total of 1,777 CTs met the inclusion criteria, and 223 CTs were discontinued between January 1, 2020 and August 1, 2021. Thirty-three (14.8%) of the 223 CTs 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 Of the 33 CTs, 19 (57.6%) were suspended, 9 (27.3%) were terminated, and 5 (15.2%) were withdrawn.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 (interquartile range [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<0.001). There were no significant associations between trial location, funding source, randomization, or whether a study involved masked vs unmasked participants.
The COVID-19 pandemic has incited an impact on clinical research in the field of otolaryngology. To preserve trial continuation amid future threats to participant interaction and communication, we recommend further exploration of remote monitoring practices and virtual procedures-those that 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.
由于招募困难、供应链短缺和资金短缺，COVID-19 大流行降低了进行医学研究的能力。耳鼻喉科的临床实践受到了特别影响，因为面部整形手术和声带注射等选择性手术减少了。
主要目的是检查 COVID-19 大流行对耳鼻喉科领域临床试验（CTs）的破坏程度。
2021 年 8 月 1 日，我们利用 ClinicalTrials.gov 对常见耳鼻喉科疾病的 CTs 进行了系统搜索。我们使用 2020 年 1 月 1 日至 2021 年 8 月 1 日的日期范围来确定所有可能受到 COVID-19 大流行影响的试验。调查人员以重复、掩蔽的方式进行筛选和数据提取。从搜索中提取的试验结果包括试验状态、治疗的疾病、入组人数、资金、研究类型、研究设计、最后更新发布日期和试验地点。明确将 COVID-19 作为终止或暂停的原因的试验被编码为这种情况。对于没有明确提及 COVID-19 的试验，我们从 ClinicalTrials.gov 提供的原因进行编码。俄克拉荷马州立大学健康科学中心机构审查委员会确定该项目不符合人体研究标准。
共有 1777 项 CT 符合纳入标准，2020 年 1 月 1 日至 2021 年 8 月 1 日期间有 223 项 CT 被停止。其中 33 项（14.8%）明确因 COVID-19 而停止。这 33 项研究共纳入 1715 名参与者。在主要干预措施中，11 项（33.3%）为器械，10 项（30.3%）为药物，5 项（15.2%）为行为，4 项（12.1%）为诊断测试，1 项（3.0%）为饮食，2 项（6.1%）为“其他”。关于 CT 地点，20 项（60.6%）在美国进行，13 项（39.4%）在国际上进行。在 33 项 CT 中，19 项（57.6%）被暂停，9 项（27.3%）被终止，5 项（15.2%）被撤回。试验中断的最常见原因是招募困难（24.2%）。由于 COVID-19 而停止的试验的中位入组人数为 37（四分位距[IQR]，19-71），其他原因的中位入组人数为 6（IQR，0-27），Mann-Whitney 检验显示两者之间存在统计学显著差异（z=-3.913，p<0.001）。试验地点、资金来源、随机化以及研究是否涉及掩蔽或非掩蔽参与者之间没有显著关联。
COVID-19 大流行对耳鼻喉科领域的临床研究产生了影响。为了在未来对参与者互动和交流的威胁下保持试验的连续性，我们建议进一步探索远程监测实践和虚拟程序，这些程序将保持建立新疗法所需的有效性和准确性。我们鼓励未来的试验评估哪些远程评估显示出最大的有效性，长期目标是建立对未来大流行具有弹性的创新研究设计。
