Abstract
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.
Highlights
The coronavirus disease 2019 (COVID-19) pandemic has had a worldwide impact with serious clinical manifestations including death on the population [1]
This study focuses on the impact of COVID-19 outbreak on global or domestic multicenter clinical trials that have been carried out and are currently being enrolled and followed up or will be carried out to begin, discusses what changes are certain to occur and whether they will affect the quality, schedule in clinical trials, and safety of subjects; and the paper doesn’t discuss clinical trials of COVID-19 drug study [3]
The content of the interview mainly focused on the difficulties encountered in the implementation and promotion of clinical trials and the effect of solutions tried in the context of COVID-19 pandemic
Summary
The coronavirus disease 2019 (COVID-19) pandemic has had a worldwide impact with serious clinical manifestations including death on the population [1]. Clinical trial is the most important and necessary part of drug research and development, different from the diagnosis and treatment process of ordinary patients, the implementation of clinical trials must strictly comply with the trial protocol, ethics and relevant regulations in addition to the common diagnosis and treatment process. During such a large epidemic period, sponsors of clinical trials, investigators in research institutions, subjects (patients involved in clinical trials) and all faced many difficulties, and the working process of drug clinical trials faced multiple negative dilemmas and had to change. This study focuses on the impact of COVID-19 outbreak on global or domestic multicenter clinical trials that have been carried out and are currently being enrolled and followed up or will be carried out to begin, discusses what changes are certain to occur and whether they will affect the quality, schedule in clinical trials, and safety of subjects; and the paper doesn’t discuss clinical trials of COVID-19 drug study [3].
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
