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

Abstract

Background: The number of Chinese clinical trials has continued to grow throughout the coronavirus disease 2019 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.

Despite negative perceptions of clinical trial conduct during the coronavirus disease 2019 (COVID-19) pandemic, are decentralized clinical trial methods here to stay?

“…With the support of health authority guidance documents (1)(2)(3), procedural changes that were implemented include, but are not limited to, subject visits being conducted via telephone or video, informed consent being obtained electronically, investigational drug being delivered directly to subjects' homes, and remote entry and monitoring of study data. Zhu et al (4), conducted a survey of clinical research staff across China to assess perceptions on how procedural changes resulting from the COVID-19 pandemic impacted four core areas: subject enrollment, patient care, study supplies and data management, and research milestones and quality management. The results of the survey support findings from several other studies (5)(6)(7)(8)(9)(10)(11); yet, decentralized clinical trials are becoming more prevalent post-pandemic.…”

Analysis of the Laser Epilation in Pilonidal Disease Trial

“…Second, the interruptions caused by the COVID-19 pandemic, particularly the delayed treatments and additional follow-up extending beyond the initial protocol, may have introduced confounding variables that were not adequately accounted for in the analysis. The pandemic’s impact on health care access and patient attitudes toward hospital visits might have influenced both treatment adherence and reporting of outcomes . In addition, the study reports a compliance rate of 60.3% in the LE group for completing the laser treatment sessions within the specified time frame.…”