Management And Quality Control Of Clinical Trials Under The Epidemic Of COVID-19

Objective:Since 2019,the large-scale and continuous epidemic of Coronavirus Disease 2019(COVID-19)has brought great challenges to clinical trials,not only seriously affects the progress and quality of clinical trials,but also threatens the health,safety and rights of subjects.By analyzing the existing laws,regulations and guidelines for clinical trials,this study mainly explored the impact of the epidemic on the key links of clinical trials and the countermeasures that can be taken.The operating model in this study of how to carry out clinical trials in a scientific,standardized and efficient manner under COVID-19,can also provide reference for the countermeasures of clinical trials under other public health emergencies.Method:1.Literature review: Search and collect relevant regulatory guidelines,literatures,through reading,sorting,generalizing,summarizing and analyzing them,gain an in-depth understanding of the research background and the current status of clinical trials under the epidemic and suggestions made by experts and scholars.2.Comparative analysis: Collect information on the number of new registrations of clinical trials at home and abroad from 2018 to 2022,analyze and compare the changes in the number before and after the epidemic,and discuss the impact of the epidemic on it;collect the guidance documents issued by domestic and foreign regulatory agencies in response to the epidemic,and compare and analyze the construction content.3.Questionnaire survey : A questionnaire survey was conducted based on the clinical trials affected by the epidemic and the current situation,in-depth understanding and statistical analysis of the current situation of clinical trials under the epidemic and the opinions of all parties involved in the trials.Result:1.Through literature review and comparative analysis,based on the important links and key influencing factors of clinical trials,the“Questionnaire on Clinical Trials Affected by Epidemic and Status Quo”was formulated.After consultating by industry experts and 26 preliminary survey results,the questionnaire was adjusted to ensure the rationality and feasibility.It is finally composed of 28 questions in five parts.2.A total of 250 questionnaires were distributed,241 were recovered,and 231 were valid questionnaires.The survey results indicated that 69.26%(160/231)of the respondents said that the trial work was relatively affected by the epidemic,mainly due to the difficulty of follow-up and administration of subjects,accounting for 62.77%(145/231).80.08%(185/231)of the research were carried out normally according to the protocol,57.71%(101/175)of the homebase indicated that the effect was average,and 69.7%(161/231)of the research sites made an appointment by email or telephone before accepting it on site.74.03%(172/231)believed that there were more protocol deviations after the epidemic,and the main types were out-ofwindow visits and lack of visit-related inspections,accounting for 74.46%(172/231)and 54.55%(126/231),respectively,and 72.79%(167/231)of people worried that the increase of protocol deviation was the biggest factor affecting the quality of the trial.87.45%(202/231)of the respondents believed that the timeliness of trial data had the greatest impact,and people had the highest expectations for opening a green channel for clinical trials and promoting the construction of a remote monitoring system,accounting for 71.43%(165/231)and 69.7%(161/231).Conclusion:The COVID-19 epidemic has a continuous impact on different links and levels of clinical trials,and there are certain risks in the safety and rights of subjects,the timeliness and integrity of research data,and the expected progress and scientific standardization of clinical trial.All parties involved in the trial should strengthen communication and collaboration,strengthen process management and quality control,improve emergency response and risk response capabilities under public health emergencies,and jointly explore the best management model for clinical trials during the spreading epidemic.