Chen Zhimin, Chen Liran, Chen Huafang
Ningbo Hospital of Traditional Chinese Medicine, Zhejiang, China.
Tang Wealth Investment Management Co. Ltd, Shanghai, China.
PLoS One. 2021 May 11;16(5):e0251410. doi: 10.1371/journal.pone.0251410. eCollection 2021.
The objective of this study was to explore the impact of the coronavirus disease 2019 epidemic on ongoing and upcoming drug clinical trials. Qualitative semi-structured interviews were conducted with clinical trial staff and clinical trial subjects were surveyed by questionnaire in this study. The results of interviews and questionnaire showed that coronavirus disease 2019 pandemic has led to many changes in the implementation of drug clinical trials, including: a variety of meetings being held online webinars using various platforms, telemedicine and follow-up by video, A large number of deviations from protocol and losses of follow-up, delivery of clinical trial drugs by express, additional workload caused by screening for coronavirus, and anxiety of subjects. These results suggest that the coronavirus disease 2019 outbreak has hindered the progress and damaged the quality of clinical trials. The online meeting, remote follow-up, express delivery of drugs and remote monitoring in the epidemic environment can ensure the progress of clinical trials to a certain extent, but they cannot fully guarantee the quality as before.
本研究的目的是探讨2019冠状病毒病疫情对正在进行和即将开展的药物临床试验的影响。本研究对临床试验工作人员进行了定性半结构式访谈，并通过问卷调查了临床试验受试者。访谈和问卷调查结果显示，2019冠状病毒病大流行导致药物临床试验的实施发生了许多变化，包括：使用各种平台通过在线网络研讨会召开各种会议、远程医疗和视频随访、大量方案偏离和随访失访、通过快递交付临床试验药物、筛查冠状病毒导致的额外工作量以及受试者的焦虑情绪。这些结果表明，2019冠状病毒病疫情阻碍了临床试验的进展并损害了其质量。疫情环境下的在线会议、远程随访、药物快递交付和远程监测在一定程度上可以确保临床试验的进展，但无法像以前那样充分保证质量。
