Real-world data: basic definitions
https://doi.org/10.24884/1609-2201-2025-104-2-11-18
Abstract
It is well known that by analyzing data from real clinical practice, it is possible to study current issues in the health and social care systems, generalize the personal experiences of patients, and consider the impact of medical technologies on various drug outcomes, from clinical to socio-economic.
About the Authors
I. R. SvechkarevaRussian Federation
Izabella R. Svechkareva, resident of the department of Clinical Pharmacology and Evidence-Based Medicine
6–8, L’va Tolstogo str., Saint Petersburg, 197022
A. H.-M. Valeeva
Russian Federation
Altynai H.-M. Valeeva, resident of the department of Clinical Pharmacology and Evidence-Based Medicine
Saint Petersburg
T. I. Busheva
Russian Federation
Tatiana I. Busheva, resident of the department of Clinical Pharmacology and Evidence-Based Medicine
Saint Petersburg
A. S. Kolbin
Russian Federation
Alexey S. Kolbin, Dr. of Sci. (Med.), Professor, Associate Professor, Department of Clinical Pharmacology and Evidence-Based Medicine; associate professor, Department of Pharmacology
St. Petersburg
References
1. Decision of the EEC Council No. 78 (as amended on 17.03.2022) “On Amendments to the Rules for Registration and Expertise of Medicines for Medical Use”. URL: https://docs.eaeunion.org/docs/ru-ru/01431480/err-18032022-36 (accessed: 10.07.2025). (In Russ.).
2. Framework for FDA’s Real-World Evidence Program. December 2018. URL: https://www.fda.gov/media/120060/download (accessed: 10.07.2025).
3. “Guiding Principles of Real-World Evidence supporting Drug Development and Review (Trial)” is formally promulgated by NMPA. URL: https://www.accestra.com/guiding-principles-of-real-world-evidence-supporting-drug-development-and-review-trial-is-formally-promulgated-by-nmpa/ (accessed: 10.07.2025).
4. NICE real-world evidence framework, Corporate document. Published: 23 June 2022. URL: www.nice.org.uk/corporate/ecd9 (accessed: 10.07.2025).
5. Jaksa A., Wu J., Jónsson P. et al. Organized structure of real-world evidence best practices: moving from fragmented recommendations to comprehensive guidance. J. Comp. Eff. Res. 2021;10(9):711–731. https://doi.org/10.2217/cer-2020-0228.
6. Honig P. K. Real-World Evidence and the Regulation of Medicines. Clin. Pharmacol. Ther. 2021;109(5):1169–1172. PMID: 33870489.
7. Haynes B. Can it work? Does it work? Is it worth it? The testing of healthcare interventions is evolving. BMJ. 1999;319(7211):652–653. https://doi.org/10.1136/bmj.319.7211.652
8. Cochrane A. L. Effectiveness and efficiency: random reflection on health services. London: Nuffield Provincial Hospitals Trust, 1972. https://doi.org/10.1016/S0033-3506(73)80082-4.
9. High Level Pharmaceutical Forum 2005–2008. Final Conclusions and Recommendations of the Pharmaceutical Forum. URL: http://www.bgpharma.bg/bulletin/read/edition/8/file/final-conclusions-en.pdf (accessed: 07.04.2020).
10. Clinical Trials Management / edited by Belousov D. Yu., Zyryanova S. K., Kolbin A. S. 1st ed. Moscow: Buki Vedi: OKI Publishing House, 2017. 676 p.: ill. URL: https://izdat-oki.ru/upravlenie-klinicheskimi-issledovaniyami (accessed: 07.04.2020). (In Russ.).
11. Eichler H. G., Abadie E., Breckenridge A. et al. Bridging the efficacy-effectiveness gap: a regulator’s perspective on addressing variability of drug response. Nat. Rev. Drug. Discov. 2011;10(7):495–506. https://doi.org/10.2147/CLEP.S121991.
12. Nordon C., Karcher H., Groenwold R. H. et al. The “Efficacy-Effectiveness Gap”: Historical Background and Current Conceptualization. Value Health. 2016;19(1):75–81.
13. Pharmacovigilance / edited by Kolbin A.S., Zyryanova S.K., Belousov D.Yu. M.: OKI Publishing House: Buki Vedi, 2019. 248 p.: ill. (In Russ.).
14. Dijkstra L., Garling M., Foraita R., Pigeot I. Adverse drug reaction or innocent bystander? A systematic comparison of statistical discovery methods for spontaneous reporting systems. Pharmacoepidemiol. Drug. Saf. 2020;29(4):396–403. https://doi.org/10.1002/pds.4970.
15. Real-World Evidence Transparency Initiative. URL: https://www.ispor.org/strategic-initiatives/real-world-evidence/real-world-evidence-transparency-initiative (accessed: 20.04.2025).
16. EQUATOR. URL: https://www.equator-network.org/reporting-guidelines/ (accessed: 20.04.2025).
17. The Editors Of The Lancet Group. Learning from a retraction. Lancet. 2020;396(10257):1056. https://doi.org/10.1016/S0140-6736(20)31958-9.
18. Perez-Gutthann S., Arana A., Margulis A. ENCePP Guide on Methodological Standards in Pharmacoepidemiology. The current version of the Guide is Revision 10, dated 30 June 2022. URL: https://www.rtihs.org/publications/encepp-guide-methodological-standards-pharmacoepidemiology-10th-edition (accessed: 20.06.2025).
19. Lavertu A., Vora B., Giacomini K. M. et al. A New Era in Pharmacovigilance: Toward Real-World Data and Digital Monitoring. Clin. Pharmacol. Ther. 2021;109(5):1197–1202. https://doi.org/10.1002/cpt.2172.
20. Research of real clinical practice. Updated recommendations of 2023 / edited by Kolbin A.S. Moscow: OKI Publishing House, 2023. 222 p.: ill. ISBN 978-5-907715-17-2. (In Russ.).
Review
For citations:
Svechkareva I.R., Valeeva A.H., Busheva T.I., Kolbin A.S. Real-world data: basic definitions. New St. Petersburg Medical Records. 2025;(2):11-18. (In Russ.) https://doi.org/10.24884/1609-2201-2025-104-2-11-18
