Division of Orthopaedic Surgery, Center for Evidence Based Orthopaedics, McMaster University, Hamilton, Ontario, Canada.
Northern Ontario School of Medicine, Lakehead University, Thunder Bay, Canada.
Int Orthop. 2020 Aug;44(8):1467-1471. doi: 10.1007/s00264-020-04625-7. Epub 2020 May 24.
The purpose of this review is to quantify the landscape of current clinical trials ongoing for therapies in the treatment of COVID-19. A secondary purpose is to examine the relationship between public and scientific interests in potential therapies for COVID-19.
A systematic search of clinicaltrials.gov was undertaken on April 22, 2020, to identify all currently registered clinical trials investigating potential therapies for patients with COVID-19. Public interest in the various therapies was quantified utilizing Google Trends. Public interest in hydroxychloroquine and chloroquine was plotted against the cumulative number of active clinical trials evaluating antimalarials as potential COVID-19 therapies over time.
There were 341 interventional studies and 208 different therapies actively registered on clinicaltrials.gov whose primary aim is the treatment of COVID-19. The median sample size was 120 patients (range 4-6000) with 154 (45%) trials reporting a planned sample size of 100 patients or less. There was a strong positive correlation (r = 0.76, p = 0.01) between the number of registered clinical trials and the public interest in the top ten proposed therapies. Following the spike in public interest, the average number of new trials increased tenfold with respect to antimalarial therapies.
The relatively small sample sizes and the number of independent trials investigating similar therapies are concerning. Resources may not be being allocated based on scientific merit and may be driven by public consciousness and speculation. Moving forward, a concerted effort focused on implementing large, well-coordinated and carefully designed multi-armed clinical trials will help to ensure that the most promising therapeutic options are rigorously studied and clinically meaningful results produced.
本综述旨在量化目前正在进行的治疗 COVID-19 的疗法的临床试验格局。次要目的是研究公众对 COVID-19 潜在疗法的兴趣与科学界对其的兴趣之间的关系。
2020 年 4 月 22 日，我们对 clinicaltrials.gov 进行了系统检索，以确定所有正在注册的针对 COVID-19 患者的潜在疗法的临床试验。利用 Google Trends 量化各种疗法的公众关注度。将羟氯喹和氯喹的公众关注度与评估抗疟药作为 COVID-19 潜在疗法的活跃临床试验的累计数量进行对比。
有 341 项干预性研究和 208 种不同的疗法在 clinicaltrials.gov 上进行了积极注册，其主要目的是治疗 COVID-19。中位数样本量为 120 例（范围 4-6000），154 项（45%）试验报告计划样本量为 100 例或更少。注册临床试验数量与公众对十大建议疗法的关注度之间存在很强的正相关（r = 0.76，p = 0.01）。在公众关注度飙升之后，抗疟药的新试验数量增加了十倍。
样本量相对较小，且研究类似疗法的独立试验数量众多，这令人担忧。资源的分配可能不是基于科学价值，而是受到公众意识和猜测的驱动。未来，需要集中精力实施大型、协调一致和精心设计的多臂临床试验，以确保最有前途的治疗选择得到严格研究，并产生有临床意义的结果。
