A Review of the Importance and Relevance of Real-World Data and Real-World Evidence

27 August 2025 : Review article

Dinah V. Parums^{BCDEF 1*}

DOI: 10.12659/MSM.951118

Med Sci Monit 2025; 31:e951118

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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

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Table 1 Comparison of real-world data and data from controlled clinical trials and studies [10,11].

	Real-world data	Data from controlled clinical trials and studies
	Effectiveness/response	Efficacy
	Real-world clinical practice	Controlled research
	No strict criteria for patient inclusion	Strict criteria for patient inclusion
	Patient-centered	Investigator-centered
	Real-world clinical practice	Only included according to the study protocol
	Multiple physicians, as decided by the patient	Designated investigator
	Patient need, real-world and variable treatments, as determined by the market and physician	Placebo or standard care
	Variable treatments, as determined by the market and physician	Fixed, according to the study protocol
	Variable	Continuous through the study
	Determined by real-world clinical practice	Variable, according to the study protocol

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