Real world data (RWD) in medicine is data derived from a number of sources that are associated with outcomes in a heterogeneous patient population in real-world settings, including but not limited to electronic health records,

health insurance Health insurance or medical insurance (also known as medical aid in South Africa) is a type of insurance that covers the whole or a part of the risk of a person incurring medical expenses. As with other types of insurance, risk is shared among ma ...

claims and patient surveys. While no universal definition of real world data exists, researchers typically understand RWD as distinct from data sourced from randomized clinical trials.

Real world data (RWD) in healthcare

Real-world data refer to observational data as opposed to data gathered in an experimental setting such as a randomized controlled trial (RCT). They are derived from

electronic health record An electronic health record (EHR) is the systematized collection of patient and population electronically stored health information in a digital format. These records can be shared across different health care settings. Records are shared throu ...

s (EHRs), claims and billing activities, product and disease registries, etc. A systematic scoping review of the literature suggests data quality dimensions and methods with RWD is not consistent in the literature, and as a result quality assessments are challenging due to the complex and heterogeneous nature of these data. The sources of RWD are only rarely

interoperable Interoperability is a characteristic of a product or system to work with other products or systems. While the term was initially defined for information technology or systems engineering services to allow for information exchange, a broader defi ...

, as each hospital-maintained EHR system is, by design, secured for patient privacy. Healthcare providers responsible for entering patient data into their EHR may agree to pooling that data with others, once it has been de-identified in accordance with privacy regulations such as

HIPAA The Health Insurance Portability and Accountability Act of 1996 (HIPAA or the Kennedy– Kassebaum Act) is a United States Act of Congress enacted by the 104th United States Congress and signed into law by President Bill Clinton on August 21, 19 ...

or GDPR. The result is a larger, more heterogenous population for research, where trends and statistical associations may be more apparent. Results from analysis on aggregated RWD can inform the design of clinical study protocols or advance post-approval research.

Real world evidence (RWE)

When working with RWD, the goal is often to generate evidence. The term

real world evidence Real-world evidence (RWE) in medicine is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data (RWD). RWE can be generated by different study designs or analyses, i ...

(RWE) is highly related to RWD. RWE is defined by FDA as "clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD". An example of a study utilizing RWE is "
Clinical Features and Outcomes of Coronavirus Disease 2019 Among People Who Have HIV in the United States: A Multi-center Study From a Large Global Health Research Network (TriNetX)"
' In this study, Covid-19 outcomes were compared between people with HIV and HIV-negative controls from a database of de-identified health records. The TriNetX platform allowed the researchers to consider the HIV and HIV-negative subjects in incidence of hospitalizations, ICU admissions, ventilation and severe disease, to understand the impact Covid-19 infection has on those with HIV.

Regional context

US context

In December 2018, the

FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...

published a framework for Real World Evidence program.

EU context

In 2018, the EMA published a discussion paper on the use of patient disease registries for regulatory purposes (methodological and operational considerations).. In 2022, UK's National Institute for Health and Care Excellence published its RWE Framework that sets out how RWE could inform health technology assessment.

References

Citations

Sources

* Real-World Evidence—What Is It and What Can It Tell Us? The New England Journal of Medicine, Dec. 6, 2016 * 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.

External links

"Real World Evidence"
at

Real world data
a
TriNetX, LLC
Evidence Health informatics Clinical research {{health-stub