Real-World Data

What is Real-World Data?   Real-world data is defined as patient health and healthcare delivery data obtained from real-world situations, observational, or noninterventional settings outside of the data collected from randomized clinical trials.

What are Sources of Real-World Data?

Potential sources of real-world data include:

  • Electronic health records (EHRs)
  • Patient registries
  • Billing and claims databases
  • Adverse event reporting systems
  • Digital health monitoring devices
  • Patient-powered research networks

What is the Impact of Real-World Data?

Gathering real-world data is quicker, more cost-effective, and more efficient as it is usually readily available. Analysis of this data can provide real-world evidence (RWE) for:

  • Efficacy of new interventions or standard of care
  • Safety concerns and rare adverse events
  • Potential for unmet needs
  • Evaluation of natural history of disease
  • Incidence and prevalence of disease
  • Health economics

Source: Chodankar, D. (2021). Introduction to real-world evidence studies. Perspectives in Clinical Research, 12(3), 171.