The concept of an ideal real-world evidence study: industry opinion
https://doi.org/10.37489/2782-3784-myrwd-090
EDN: VIMRPC
Abstract
Introduction. Real-world evidence (RWE) plays a critical role in pharmaceutical companies at all stages of a medical product’s life cycle. Contract research organizations and research infrastructure suppliers ensure that RWE studies. Understanding what the industry thinks about an ideal ecosystem is important for conducting high-quality RWE studies.
Objective. To identify the strengths and weaknesses of existing RWE study processes in Russia, needs, and proposals in this area, which can later be used by key parties of the RWE ecosystem to create a regulatory framework and ensure the methodology and quality of RWE studies. The objective was to develop an ideal RWE ecosystem model.
Materials and methods. The study used semi-structured in-depth interviews with experts in the RWE field: 10 pharmaceutical companies, 6 CROs, and 3 providers of study infrastructure. From September 23 to November 14, 2025, 19 expert interviews were conducted, each of which included 23 questions combined into 4 blocks: 1) a description of the respondents, 2) problems in conducting RWE studies, 3) ensuring RWE study quality, and 4) regulatory needs.
Results. The analysis of the respondents’ answers enabled the identification of eight interrelated components that form the ideal RWE ecosystem model: regulatory certainty and regulatory framework, quality of source data, data infrastructure, study parties’ competencies, quality management systems, study planning, transparency and traceability, financing, and resource ensuring.
Conclusion. The ideal RWE model is a complex ecosystem that requires the coordinated development of regulatory, organizational, technological, and educational components.
About the Authors
T. A. Goldina
Russian State University for the Humanities
Russian Federation
Russian Federation
Tatiana A. Goldina — Cand. Sci. (Biol.), independent researcher
Moscow
Yu. V. Khomitskaya
Servier JSC
Russian Federation
Russian Federation
Yunona V. Khomitskaya — Cand. Sci. (Med.), medical department
Moscow
References
1. The 21st Century Cures Act (Cures Act). 2016. https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
2. Framework for FDA’s Real-World Evidence Program December 2018 https://www.fda.gov/media/120060/download
3. Data Analysis and Real-World Interrogation Network (DARWIN EU). https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/real-world-evidence/data-analysis-real-world-interrogation-network-darwin-eu
4. ICH reflection paper on pursuing opportunities for harmonisation in using real-world data to generate real-world evidence, with a focus on effectiveness of medicines. July 2024 https://www.ema.europa.eu/en/documents/scientific-guideline/ich-reflection-paper-pursuing-opportunities-harmonisation-using-real-world-data-generate-realworld-evidence-focus-effectiveness-medicines_en.pdf
5. ICH M14 «General Principles on Planning, Designing, Analysing, and Reporting of Non-interventional Studies That Utilise Real-World Data for Safety Assessment of Medicines». https://www.ich.org/page/multidisciplinary-guidelines#14-1
6. Decision of the Council of the Eurasian Economic Commission No. 78 dated November 3, 2016 "On the Rules for Registration and Examination of medicines for medical use". Ссылка активна на 13.11.2025 https://docs.eaeunion.org/documents/306/2601/
7. Decision of the Council of the Eurasian Economic Commission dated 03/17/2022 No. 36 "On Amendments to the Rules for Registration and Examination of Medicines for Medical Use". Ссылка активна на 13.11.2025 https://docs.eaeunion.org/documents/401/6507/
8. Recommendations of the Council of the Eurasian Economic Commission No. 1 dated 10/18/2024 "On common approaches to the development of regulation of the circulation of medicines within the framework of the Eurasian Economic Union regarding the collection, analysis and use of data from real clinical practice." Ссылка активна на 13.11.2025 https://docs.eaeunion.org/documents/437/8378/
9. Recommendation of the EEC Board dated 06/10/2025 No. 15 "On Guidelines on the general issues of using real clinical practice data in the context of drug treatment". Ссылка активна на 13.11.2025 https://docs.eaeunion.org/documents/450/10035/
10. Generating real-world evidence at scale using advanced analytics 2022 McKinsey article https://www.mckinsey.com/industries/life-sciences/our-insights/generating-real-world-evidenceat-scale-using-advanced-analytics Доступ 10.11.2025.
11. Makady A, Stegenga H, Ciaglia A, et al. Practical implications of using real-world evidence (RWE) in comparative effectiveness research: learnings from IMI-GetReal. J Comp Eff Res. 2017 Sep;6(6):485-490. doi: 10.2217/cer-2017-0044.
12. Khosla S, White R, Medina J, Ouwens M, Emmas C, Koder T, Male G, Leonard S. Real world evidence (RWE) a disruptive innovation or the quiet evolution of medical evidence generation? F1000Res. 2018 Jan 25;7:111. doi: 10.12688/f1000research.13585.2.
13. Jaksa AA, Pavel AN, Aapro M, et al. Actions for stakeholders to develop better real-world evidence for HTA bodies/payers decision making. Int J Technol Assess Health Care. 2025 Jun 17;41(1):e52. doi: 10.1017/S0266462325100238.
14. Jansen MS, Dekkers OM, le Cessie S, Hooft L, Gardarsdottir H, de Boer A, Groenwold RHH. Multiple Perspectives on the Need for Real-World Evidence to Inform Regulatory and Health Technology Assessment Decision-Making: Scoping Review and Stakeholder Interviews. Pharmacoepidemiol Drug Saf. 2025;34(1):e70074. doi: 10.1002/pds.70074.
15. EFPIA’s Position on the Use & Acceptance of Real-World Evidence by International Markets. https://www.efpia.eu/media/602956/efpia-rwepositionpaper_aug2021.pdf Доступ 05.11.2025
16. Gorkavenko F.V., Omelyanovskiy V.V. Results of the survey of experts on the need to incorporate real-world evidence to the comprehensive drug assessment. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2025;18(3):357-364. (In Russ.).
17. Kurylev A.A., Zhuravkov A.A., Kolbin A.S. Real-world clinical practice in health technology assessment: state of the art for 2022. Real-World Data & Evidence. 2022;2(4):1-9. (In Russ.). EDN: NQARAS.
18. Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 2006;3(2):77-101. http://eprints.uwe.ac.uk/11735.
19. Arzamaskin Yu.N. The principle of historicism in scientific research. Bulletin of the Military University. 2011; 3(27)7-11.
20. Woolery L, Grzymala-Busse J, Summers S, Budihardjo A. The use of machine learning program LERS-LB 2.5 in knowledge acquisition for expert system development in nursing. Comput Nurs. 1991 Nov-Dec;9(6):227-34.
21. Caro JJ, Speckman JL. Existing treatment strategies: does noncompliance make a difference? J Hypertens Suppl. 1998 Sep;16(7):S31-4.
22. Novoderezhkina EA, Goldina TA. Real world evidence studies: problems of terminology and classification. Medical Technologies. Assessment and Choice. 2023;45(1):50–62. (In Russ.).
23. Wang SV, Pottegård A. Building transparency and reproducibility into the practice of pharmacoepidemiology and outcomes research. Am J Epidemiol. 2024 Nov 4;193(11):1625-1631. doi: 10.1093/aje/kwae087.
24. Jones MC, Stone T, Mason SM, Eames A, Franklin M. Navigating data governance associated with real-world data for public benefit: an overview in the UK and future considerations. BMJ Open. 2023 Oct 4;13(10):e069925. doi: 10.1136/bmjopen-2022-069925.
25. European Health Data & Evidence Network (EHDEN) https://www.ehden.eu/ Доступ 10.11.2025.
Review
For citations:
Goldina T.A., Khomitskaya Yu.V. The concept of an ideal real-world evidence study: industry opinion. Real-World Data & Evidence. 2025;5(4):70-80. (In Russ.) https://doi.org/10.37489/2782-3784-myrwd-090. EDN: VIMRPC
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