Real world data are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources apart from traditional clinical trials. The sources of real-world data can be electronic health records (EHRs), claims and billing activities, country/region registries, patient-related activities in out-patient or in-home use settings and health-monitoring devices etc. Real World Study (RWS) is scientific research carried out through rigorous study design and analysis plan based on real world data. Real world evidence is the clinical evidence obtained by using epidemiology methods to analyze real world data through real world study. The epidemiological approaches include but not limited to prospective and retrospective cohort study, case-control study and time series analysis, etc.
In medical and health industrial, more attention has been paid to real world studies. Real world studies are mainly used in feasibility assessment, disease burden study, pre-market epidemiology study, post-market safety surveillance and effectiveness study, and health economics study, etc.
Meta analysis；Sample size calculation (clinical or post-market trials); Re-analysis of existing clinical data.