[Conducting clinical studies during the epidemics of communicable diseases: perspectives of methodology and health economics].

Gong, Mengchun; Liu, Li; Wu, Chen; Yang, Yue; Shen, Yang; Li, Jie; Lin, Kaicheng; Guo, Yi; Wei, Hongyun; Xu, Zeyu; Zhu, Hong

In the setting of epidemics of communicable diseases, early initiation of epidemiological and clinical data collection and analysis and conducting relevant researches are essential to the success of epidemic containment. The coronavirus disease 2019 (COVID-19), starting initially as an epidemic in China in late 2019 and now becoming a pandemic globally, poses grave challenges to the global health care systems while also provides an opportunity for studying infectious diseases in the perspective of methodology. The authors propose the evaluation methods for case reports, randomized controlled trials (RCTs), real-world evidence studies and health economics researches during an epidemic. Case reports, which are of important value for health care workers during outbreaks of infectious diseases, should be written in standard format and style and published following a strict peer review process. RCTs provides the gold standard for evaluating the effectiveness of a given treatment for the patients from the outbreaks. We review the potential challenges faced in conducting RCTs during the outbreaks. The real-world data collected from the cases in designated hospitals allow the verification of the safety and effectiveness of the intervention measures. The data from health economics research also provide important support for optimizing communicable disease prevention and control strategies. Herein we summarize the health economics research methods, study design, and technical points during the outbreaks. We recommend that clinical research and health economics research be incorporated into the prevention and control plan and measures be taken to ensure both the standards and feasibility of these studies to improve the response capacity against outbreaks of communicable diseases.