Real world data

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 records (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.{{Cite journal|last1=Bian|first1=Jiang|last2=Lyu|first2=Tianchen|last3=Loiacono|first3=Alexander|last4=Viramontes|first4=Tonatiuh Mendoza|last5=Lipori|first5=Gloria|last6=Guo|first6=Yi|last7=Wu|first7=Yonghui|last8=Prosperi|first8=Mattia|last9=George|first9=Thomas J|last10=Harle|first10=Christopher A|last11=Shenkman|first11=Elizabeth A|date=2020-12-09|title=Assessing the practice of data quality evaluation in a national clinical data research network through a systematic scoping review in the era of real-world data|url= |journal=Journal of the American Medical Informatics Association|language=en|volume=27|issue=12|pages=1999–2010|doi=10.1093/jamia/ocaa245|issn=1527-974X|pmc=7727392|pmid=33166397}}

The sources of RWD are only rarely interoperable, 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 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.{{Cite web|date=2021-04-26|title=TriNetX and Takeda Enter Into Agreement to Drive Access to Real-World Data and Analytics|url=https://trinetx.com/takeda-agreement/|access-date=2022-02-04|website=TriNetX|language=en-US}}

{{main|Real world evidence}}

When working with RWD, the goal is often to generate evidence. The term real world evidence (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 "[https://academic.oup.com/ofid/article/8/7/ofab272/6290905 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.{{Cite journal|last1=Yendewa|first1=George A.|last2=Perez|first2=Jamie Abraham|last3=Schlick|first3=Kayla|last4=Tribout|first4=Heather|last5=McComsey|first5=Grace A.|date=2021-07-01|title=Clinical Features and Outcomes of Coronavirus Disease 2019 Among People Who Have Human Immunodeficiency Virus in the United States: A Multi-center Study From a Large Global Health Research Network (TriNetX)|url=https://academic.oup.com/ofid/article/8/7/ofab272/6290905|journal=Open Forum Infectious Diseases|volume=8|issue=7|pages=ofab272|doi=10.1093/ofid/ofab272|pmc=8244788|pmid=34435074|via=Oxford Academic}}

In December 2018, the FDA published a framework for Real World Evidence program.{{cite web |title=Framework for FDA's Real-World Evidence Program |url=https://www.fda.gov/media/120060/download |publisher=FDA}}

In 2018, the EMA published a discussion paper on the use of patient disease registries for regulatory purposes (methodological and operational considerations).{{cite web |title=Use of patient disease registries for regulatory purposes – methodological and operational considerations |url=https://www.ema.europa.eu/documents/other/discussion-paper-use-patient-disease-registries-regulatory-purposes-methodological-operational_en.docx}} In 2022, UK's National Institute for Health and Care Excellence published its RWE Framework{{Cite web |title=Overview {{!}} NICE real-world evidence framework {{!}} Guidance {{!}} NICE |url=https://www.nice.org.uk/corporate/ecd9/chapter/overview |access-date=2022-09-06 |website=www.nice.org.uk|date=23 June 2022 }} that sets out how RWE could inform health technology assessment.

The use of real-world data from electronic health records and digital health-monitoring devices is also given as an example of general Post-Market Clinical Followup (PMCF) information for medical devices in the guideline "MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 (MDR)" from December 2022.https://health.ec.europa.eu/document/download/a7df24c3-d4a3-4218-a8e0-726febfa01c2_en?filename=mdcg_2022-21_en.pdf

• 21st Century Cures Act (US)
• Correlation does not imply causation
• Qualitative research
• Quantitative research
• Sentinel Initiative

{{Reflist}}

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• 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.

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• [https://www.fda.gov/ScienceResearch/SpecialTopics/RealWorldEvidence/default.htm "Real World Evidence"] at FDA
• [https://trinetx.com/real-world-data/ Real world data] at [https://trinetx.com TriNetX, LLC]

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Category:Evidence

Category:Health informatics

Category:Clinical research