Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2022 Nov 5;22(1):287.
doi: 10.1186/s12874-022-01768-6.

Real-world data: a brief review of the methods, applications, challenges and opportunities

Affiliations
Review

Real-world data: a brief review of the methods, applications, challenges and opportunities

Fang Liu et al. BMC Med Res Methodol. .

Erratum in

Abstract

Background: The increased adoption of the internet, social media, wearable devices, e-health services, and other technology-driven services in medicine and healthcare has led to the rapid generation of various types of digital data, providing a valuable data source beyond the confines of traditional clinical trials, epidemiological studies, and lab-based experiments.

Methods: We provide a brief overview on the type and sources of real-world data and the common models and approaches to utilize and analyze real-world data. We discuss the challenges and opportunities of using real-world data for evidence-based decision making This review does not aim to be comprehensive or cover all aspects of the intriguing topic on RWD (from both the research and practical perspectives) but serves as a primer and provides useful sources for readers who interested in this topic.

Results and conclusions: Real-world hold great potential for generating real-world evidence for designing and conducting confirmatory trials and answering questions that may not be addressed otherwise. The voluminosity and complexity of real-world data also call for development of more appropriate, sophisticated, and innovative data processing and analysis techniques while maintaining scientific rigor in research findings, and attentions to data ethics to harness the power of real-world data.

Keywords: Artificial intelligence; Causal inference; Electronic health records; Machine learning; Real-world data (RWD); Real-world evidence (RWE).

PubMed Disclaimer

Conflict of interest statement

Both authors are Senior Editorial Board Members for the journal of BMC Medical Research Methodology.

Figures

Fig. 1
Fig. 1
RWD Types and Sources (source: Fig. 1 in [16] with written permission by Dr. Brandon Swift to use the figure)
Fig. 2
Fig. 2
Challenges in RWD and Their Relations

References

    1. US Food and Drug Administration, et al. Real-World Evidence. 2022. https://www.fda.gov/science-research/science-and-research-special-topics.... Accessed 1 Sep 2022.
    1. Wikipedia. Real world data. 2022. https://en.wikipedia.org/wiki/Real_world_data. Accessed 19 Mar 2022.
    1. Powell AA, Power L, Westrop S, McOwat K, Campbell H, Simmons R, et al. Real-world data shows increased reactogenicity in adults after heterologous compared to homologous prime-boost COVID-19 vaccination, March- June 2021, England. Eurosurveillance. 2021;26(28):2100634. doi: 10.2807/1560-7917.ES.2021.26.28.2100634. - DOI - PMC - PubMed
    1. Hunter PR, Brainard JS. Estimating the effectiveness of the Pfizer COVID-19 BNT162b2 vaccine after a single dose. A reanalysis of a study of ’real-world’ vaccination outcomes from Israel. medRxiv. 2021.02.01.21250957. 10.1101/2021.02.01.21250957.
    1. Henry DA, Jones MA, Stehlik P, Glasziou PP. Effectiveness of COVID-19 vaccines: findings from real world studies. Med J Aust. 2021;215(4):149. doi: 10.5694/mja2.51182. - DOI - PMC - PubMed

MeSH terms