Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, National Jewish Health, Denver, CO; Department of Pediatrics, National Jewish Health, Denver, CO; Department of Biomedical Research, National Jewish Health, Denver, CO.
Division of Environmental and Occupational Health Sciences, Department of Medicine, National Jewish Health, Denver, CO.
Chest. 2021 Mar;159(3):1173-1181. doi: 10.1016/j.chest.2020.11.001. Epub 2020 Nov 13.
The clinical research we do to improve our understanding of disease and to develop new therapies has temporarily been delayed as the global health-care enterprise has focused its attention on those impacted by coronavirus disease 2019 (COVID-19). Although rates of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are decreasing in many areas, many locations continue to have a high prevalence of infection. Nonetheless, research must continue and institutions are considering approaches to restarting non-COVID-related clinical investigation. Those restarting respiratory research must navigate the added planning challenges that take into account outcome measures that require aerosol-generating procedures. Such procedures potentially increase risk of transmission of SARS-CoV-2 to research staff, use limited personal protective equipment, and require conduct in negative-pressure rooms. One must also be prepared to address the potential for COVID-19 resurgence. With research subject and staff safety and maintenance of clinical trial data integrity as the guiding principles, here we review key considerations and suggest a step-wise approach for resuming respiratory clinical research.
我们开展临床研究，旨在加深对疾病的认识并开发新疗法，但由于全球医疗保健机构将重点放在了受 2019 冠状病毒病（COVID-19）影响的人群上，我们的研究暂时被搁置。虽然在许多地区，严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）感染率正在下降，但许多地方的感染率仍然很高。然而，研究必须继续进行，各机构正在考虑重启与 COVID-19 无关的临床研究的方法。重启呼吸道研究的人员必须应对额外的规划挑战，这些挑战需要考虑需要产生气溶胶的程序的结果测量。这些程序可能会增加 SARS-CoV-2 传播给研究人员的风险，限制个人防护设备的使用，并需要在负压室中进行。还必须准备应对 COVID-19 死灰复燃的可能性。以研究对象和工作人员的安全以及临床试验数据完整性的维护为指导原则，我们在这里审查了关键的注意事项，并提出了逐步恢复呼吸道临床研究的方法。
