Results of the survey of experts on the need to incorporate real-world evidence to the сomprehensive drug assessment

Background. Specialists in health technology assessment consider real-world evidence (RWE) a promising path for improving comprehensive drug assessment (CDA). Therefore, it is particularly important to elicit opinions from CDA experts on the necessity of incorporating RWE analysis into the assessment process.

Objective: To present the results of a survey of CDA specialists demonstrating their views on the necessity and variability of incorporating RWE into the CDA process.

Material and methods. The survey was conducted in the form of a specially developed original questionnaire between July 2024 and February 2025 among two groups: regulatory authority representatives and pharmaceutical industry representatives involved in CDA.

Results. The survey involved 29 representatives from both regulatory authorities and pharmaceutical industry. The majority of respondents support the inclusion of RWE in CDA: 96.6% of regulatory authority representatives vs 75.9% of industry representatives. The most favored assessment areas using RWE were safety, efficacy, impact on economy, and the quality of evidence base for medicinal products. The predominant view was that in decision-making, the role of RWE should be informative rather than restrictive.

Conclusion. The surveyed respondents specialising in CDA predominantly hold positive attitudes towards incorporating RWE into the assessment procedure. The support of this incorporation by experts implies that work on specific implementations of RWE in CDA is fully justified and promises to be successful.

1. Kolbin A.S. Resolution based on the results of the IV annual scientificpractical conference “Real clinical practice. Modernity and the future”. Real-World Data & Evidence. 2023; 3 (4): 1–8 (in Russ.). https://doi.org/10.37489/2782-3784-myrwd-41.

2. Kolbin A.S., Borzova M.A., Belousov D.Yu., Kalinichenko V.V. Resolution based on the results of the V annual scientific-practical conference “RWD/RWE. Possible and real”. Real-World Data & Evidence. 2024; 4 (3): 3–12 (in Russ.). https://doi.org/10.37489/2782-3784-myrwd-57.

3. Omelyanovskiy V.V., Gorkavenko F.V., Ignatyeva N.V., et al. Real-world data: principles of use in decision making and in health technology assessment. FARMAKOEKONOMIKA. Sovremennaya farmakoekonomika i farmakoepidemiologiya / FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2023; 16 (2): 283–90 (in Russ.). https://doi.org/10.17749/2070-4909/farmakoekonomika.2023.167.

4. Kolbin A.S. (Ed.) Research in real world data. Updated 2023 guidelines. Мoscow: Izdatelstvo OKI; 2023: 222 pp. (in Russ.).

5. Novoderezhkina E.A., Zyryanov S.К. The role of real world data and real world evidence in health technology assessment. FARMAKOEKONOMIKA. Sovremennaya farmakoekonomika i farmakoepidemiologiya / FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2022; 15 (3): 380–9 (in Russ.). https://doi.org/10.17749/2070-4909/farmakoekonomika.2022.120.

6. Omelyanovskiy V.V. (Ed.) Research in real world data: health technologies assessment and clinical guidelines. Мoscow: Nauka; 2024: 179 pp. (in Russ.).

7. Khabriev R.U., Sukhodolov A.P., Spasennikov B.A., et al. The decisionmaking system in the program of subsidized pharmaceutical provision. Bulletin of Baikal State University. 2018; 28 (1): 6–11 (in Russ.). https:// doi.org/10.17150/2500-2759.2018.28(1).6-11.