As the authors note, real-world evidence originates from a spectrum of studies that apply various epidemiological methods to data collected from real world settings. Real world data can be derived from a wide variety of sources from routine healthcare (electronic health records), traditional epidemiological studies (e.g. classic cohort studies), surveillance (spontaneous adverse events monitoring), administrative databases (death registers, medical claims, etc.) or personal devices (e.g. regular blood pressure measured via app). There are three general study designs including:

  • Pragmatic clinical trials
  • Observational studies (prospective)
  • Observational studies (retrospective, admin data)

The authors offer a solid summary of the Chinese experience with real world evidence. Thereafter, they propose some strategies and approaches to improve real world evidence research in China. Finally, they put forth some key points:

  • Real world evidence continues to gain more attention in China over the past five years
  • Disease registries and retrospective databases are the two main types of real world studies in China; limited resources exist for pragmatic clinical trials
  • Use of real world evidence for healthcare practice and policy decisions is limited at present although there are a growing number of government initiatives
  • China must develop an explicit real-world policy framework; reinforcing consistent and coherent technical standards, strengthening research capacity and fostering collaboration across institutions and stakeholders.
Source: NCBI

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