27 August 2025 : Review article
A Review of the Importance and Relevance of Real-World Data and Real-World Evidence
Dinah V. Parums BCDEF 1*DOI: 10.12659/MSM.951118
Med Sci Monit 2025; 31:e951118
Introduction
Real-World Data, Real-World Evidence, and Real-World Insights
How Real-World Data and Data from Controlled Clinical Trials Compare
Real-World Data from Hospital Electronic Health Records
Real-World Data from Claims Databases
Real-World Data from Patient Registries
Real-world Data from Clinical Studies
Real-World Data from Pragmatic Clinical Trials
Real-World Data from Social Media and Patient Networks
Real-World Studies: Some Lessons Learned
Guidelines for Real-World Studies
Future Directions
Conclusions
References
Table 2 Benefits of real-world evidence to key health stakeholders [10,11].
| Stakeholders | Benefits of real-world evidence |
|---|---|
| Patients | Patient access to social media, the internet, and patient support groups has raised patient awareness of clinical trial data and real-world evidence. Patient awareness has encouraged reporting of safety concerns, the effects of comorbidities, and long-term outcomes, and participation in real-world studies |
| Healthcare providers | Real-world evidence from local and national electronic health record (EHR) analysis can provide support for providers to negotiate with drug and medical device manufacturers to retain or replace treatments, evaluate cost benefits, and seek costs from manufacturers when real-world patient outcomes do not match controlled clinical trial data |
| Pharmaceutical and medical device companies | Pharmaceutical and medical device companies now use real-world evidence throughout the product lifecycle. Real-world data can improve standards and procedures for the conduct of clinical trials, provide insights into the impact of drugs and medical devices in a target patient population, inform trial design, improve clinical guidelines, facilitate financial and reimbursement decisions, support regulatory decisions, and promote new or expanded uses for marketed products |
| Regulatory safety and pharmacovigilance monitoring | Regulatory agencies use real-world evidence to monitor the safety of marketed products using traditional pharmacovigilance methods and new digital systems. For example, the US Food and Drug Administration (FDA) Sentinel Initiative infrastructure supports several external projects from a variety of stakeholders as a global learning health system []20 |
| Payers | Healthcare funders (payers) in the US use claims data to improve the affordability of new products and implement outcomes-based contracts with providers and prescribers. In the UK, the National Institute for Health and Care Excellence (NICE) includes health technology assessments (HTAs) to compare patterns of treatment and inform pricing and reimbursement decisions []40 |