Infectious diseases, which are shaped by clinical practice, pathogen evolution, shifts in healthcare systems, and societal behavior, require multifaceted responses. In recent years, real-world data (RWD) findings have been used to inform decision-making in the field of infectious diseases. The infrastructure for using diverse RWD relevant to infectious disease research is being established in Japan. Promoting the use of RWD enables approaches to answer questions that have been difficult to address with conventional clinical research and can generate reliable evidence for antimicrobial stewardship, safety evaluation, antimicrobial resistance control, and public health intervention assessment. Simultaneously, because the RWD are not collected for research, caution is warranted when interpreting the results. The volume and granularity of information, data coverage, and longitudinal follow-up differ by data source. Without understanding these properties, the use of RWD can lead to erroneous conclusions. To ensure the quality of RWD studies, the structure and limitations of each dataset must be understood, and appropriate study designs and statistical methods to address various biases must be adopted. This review outlines the characteristics of RWD available in Japan, concrete examples of their use, and key considerations when employing RWD in research, with a focus on infectious diseases.
Okada et al. (Thu,) studied this question.