Real world evidence

Real world evidence (RWE) in medicine means evidence obtained from real world data (RWD), which are observational data obtained outside the context of randomized controlled trials (RCTs) and generated during routine clinical practice. RWE is generated by analysing data which is stored in electronic health records (EHR), billing activities databases, registries, patient-generated data, mobile devices, etc.^[1] It may be derived from retrospective or prospective observational studies and observational registries. In the USA the 21st Century Cures Act required the FDA to expand the role of real world evidence.

See also

• Evidence-based medicine
• Levels of evidence
• Correlation does not imply causation
• Qualitative research
• Quantitative research

References

• Real-World Evidence — What Is It and What Can It Tell Us? The New England Journal of Medicine, Dec. 6, 2016
• Real World Evidence, FDA, June 21, 2018.
• Mahajan, Rajiv. “Real World Data: Additional Source for Making Clinical Decisions.” International Journal of Applied and Basic Medical Research 5.2 (2015): 82. PMC. Web. 5 May 2018.
• Berger, Marc L. et al. “Good Practices for Real‐world Data Studies of Treatment And/or Comparative Effectiveness: Recommendations from the Joint ISPOR‐ISPE Special Task Force on Real‐world Evidence in Health Care Decision Making.” Pharmacoepidemiology and Drug Safety 26.9 (2017): 1033–1039. PMC. Web. 5 May 2018.

External links

• "Real World Evidence" at FDA
• "21st Century Cures Act"
• "Use of Real World Data in Development Programmes" at EMA
• "Observational Health Data Sciences and Informatics"