Impact of the COVID-19 pandemic on clinical trials: a cross-sectional questionnaire study in China.

Background: The number of Chinese clinical trials has continued to grow throughout the coronavirus disease 2019 (COVID-19) pandemic, but we know little about clinical trial team members' perceptions and attitudes toward the impacts of the pandemic. This study aimed to assess the impact of the COVID-19 pandemic on clinical trials in China from the perspective of research staff to provide a deeper understanding and some recommendations for the ongoing and upcoming clinical trials during the pandemic. Methods: A nationwide cross-sectional questionnaire was distributed to respondents throughout mainland China between September 2021 and October 2021. The participants assessed the impact of the COVID-19 pandemic on clinical trials based on a 5-point Likert-type scale, and exploratory factor analysis (EFA) was used to confirm the factor structure. Descriptive statistical analysis and the Mann-Whitney test were used to discover the differences between different groups. Results: A total of 2,393 questionnaires from 272 hospitals were collected in mainland China. Factor analysis resulted in 4 factors, with a cumulative explained variance of 64.93%, as follows: subject enrollment, patient care, study supplies and data management, and research milestones and quality management. The research team members, predominantly represented by clinical research coordinators (CRCs), basically agreed with all but 3 preset scenarios of the impact of COVID-19 on clinical trials. Most respondents did not agree that the pandemic was associated with more serious adverse events (SAEs), missed reports of safety events, or any increase of unscheduled unblinding. In addition, significant differences were revealed in different age, gender, and role groups of respondents based on their views on the impact of the pandemic. Conclusions: The current pandemic situation has had a negative impact on clinical trials, especially in terms of subject recruitment and protocol compliance, yet research team members feel confident that some of the effective measures proposed in the study can moderate the negative impact.