Preamble

The VI Annual Scientific and Practical Conference with international participation "Real Clinical Practice. Possible and Real" (Moscow, September 25, 2025) was organized and conducted by the Association of Health Technology Assessment Specialists, the Association of Clinical Pharmacologists, and the St. Petersburg Chapter of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). The conference theme brought together leading specialists in the field of RWD/RWE and Real Clinical Practice.

During the Plenary Session, welcoming addresses to the conference participants were delivered by: the Chief External Specialist in Clinical Pharmacology of the Russian Ministry of Health, Academician V.I. Petrov; Deputy Minister of Health of Russia S.V. Glagolev; Rector of the First St. Petersburg State Medical University named after Academician I.P. Pavlov, Academician S.F. Bagnenko; Scientific Director of the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology, Academician A.G. Rumyantsev; Rector of Yaroslavl State Medical University, Academician A.L. Khokhlov; Rector of Smolensk State Medical University, Corresponding Member R.S. Kozlov; Scientific Director of the World-Class Genomic Research Center "Center for Predictive Genetics, Pharmacogenetics and Personalized Therapy" of the B.V. Petrovsky Russian Scientific Center of Surgery, Russian Ministry of Science and Higher Education, Academician D.A. Sychev; President of the Union of Pediatricians of Russia, Academician L.S. Namazova-Baranova; Chairman of the Standing Commission on Social Policy and Healthcare of the Legislative Assembly of St. Petersburg of the VII convocation, A.N. Rzhanenkov; Chairman of the Association of Health Technology Assessment Specialists A.S. Kolbin; Executive Director of the Association of International Innovative Pharmaceutical Companies V.V. Kukava; Executive Director of the Association of International Pharmaceutical Manufacturers L.V. Matveeva; T.I. Galimov (Data Management 365). The Plenary Session was moderated by Elena Voitsekhovskaya, a medical journalist, editor-in-chief, author, and host of medical programs.

Within the framework of seven symposia, leading Russian and international experts in the field of RWD/RWE delivered presentations: V.V. Kalinichenko (Russian Ministry of Health); T.A. Goldina (Association of International Pharmaceutical Manufacturers); R.V. Dray (GEROPHARM); N.S. Reshetova (N.N. Petrov National Medical Research Center of Oncology); M.A. Borzova (Trubor Law Bureau); Guvenc Kockaya (ECONiX Research & Yeditepe University); N. Shcherbakova (Western New England University); Nguyen Thi Thu Thuy (Hong Bang International University); S.E. Korolev (Roche Moscow); O.V. Reshetko (Saratov State Medical University named after V.I. Razumovsky); A.G. Solodovnikov (Statandocs); A.V. Matveev (Russian Medical Academy of Continuous Professional Education); E.V. Nazarova (NAERES); E.I. Alexeeva (Sechenov First Moscow State Medical University); S.K. Zyryanov (Peoples' Friendship University of Russia); E.T. Tuleutayev (Republican Center for Coordination of Orphan Diseases, Kazakhstan); M.Yu. Samsonov (R-Pharm); A.Yu. Kuzmenkov (Smolensk State Medical University); M.V. Zhuravleva (Sechenov First Moscow State Medical University); M.Yu. Frolov (Volgograd State Medical University); L.K. Valieva (AstraZeneca Pharmaceuticals); A.S. Salasyuk (Volgograd State Medical University); K.A. Kolobova (VERBA Legal); A.V. Gusev (Webiomed); E.I. Khatkova (A.S. Loginov Moscow Clinical Scientific Center); M.A. Isakov (Aston Health); D.G. Shchurov (Sechenov First Moscow State Medical University).

The symposia were moderated by: D.A. Rozhdestvensky (Department of Technical Regulation and Accreditation of the Eurasian Economic Commission), Z.M. Golant (St. Petersburg State Chemical-Pharmaceutical University), K.V. Gorelov (Roszdravnadzor), N.Z. Musina (CIS Orphan Consortium), S.K. Zyryanov (Peoples' Friendship University of Russia), M.V. Zhuravleva (Research and Development Institute of the Federal State Budgetary Institution "National Center for Expert Evaluation of Medical Products"), Yu.A. Zhulev (All-Russian Hemophilia Society).

A separate symposium "Real-World Data in Orphan Diseases" was held as part of the VI conference.

Conference participants discussed tools for researching real-world clinical practice, the growing importance of Real-World Clinical Practice in modern medicine, legislation, and global perspectives worldwide, in Russia, and in the EAEU.

A total of 27 reports were presented at the conference.

RESOLUTION

on the results of the VI Annual Scientific and Practical Conference with international participation "Real Clinical Practice. Possible and Real", held on September 25, 2025. The text uses the term and abbreviation "Real Clinical Practice" (RCP), which combines the two international terms: RWD (Real-World Data) – data related to a patient's health status and/or the process of providing medical care, obtained from various sources; RWE (Real-World Evidence) – evidence obtained from the analysis of real-world clinical practice data – clinical evidence regarding the use and potential benefits or risks of using a medicinal product, obtained through the collection and analysis of real-world clinical practice data [Decision of the EEC Council No. 78 (as amended on March 17, 2022) "On Amending the Rules for Registration and Expertise of Medicinal Products for Medical Use"].

Conference participants noted the positive developments that have occurred since the previous conference.

Within the framework of the Eurasian Economic Union (EAEU) working group, an expert group was formed, which developed a series of guidance documents (a roadmap) for the collection, analysis, and application of real-world clinical practice (RWD/RWE) data:

At the end of 2024, the Council of the Eurasian Economic Commission (EEC) approved Recommendation No. 1 dated October 18, 2024, defining general approaches to the development of regulations for the circulation of medicinal products in the EAEU regarding the collection, analysis, and use of RWD/RWE (RWD/RWE Concept);

At the beginning of 2025, the EEC Board adopted Recommendation No. 15 dated June 10, 2025, approving the Guidance on Key Issues of Using Real-World Clinical Practice Data in the Process of Medicinal Product Circulation in the Union;

As of autumn 2025, 3 recommendations are at various stages of development and discussion.

These documents aim to form unified principles and methods for working with RWD/RWE to support regulatory decisions, improve the quality of pharmacovigilance, and develop digital technologies in healthcare in the EAEU countries and Russia.

Systemic issues requiring immediate resolution were presented for discussion by the conference participants.

Main Body

I. The following limitations for the implementation of RWD and evidence derived from it were identified during the conference.

In regulatory framework in Russia at the national level:

In the use of RWD and RWE in health technology assessment in Russia at the national level:

In the use of RWD and RWE in the development of clinical guidelines in Russia at the national level:

In the use of RWD and RWE in the implementation of innovative drug supply models in Russia at the national level:

In the implementation of information systems as a source of RWD in Russia at the national level:

In obtaining RWD from registries in Russia at the national level:

In the field of personal data protection and processing:

In improving the model for organizing the storage of medical data in the Russian Federation:

In regulatory framework at the EAEU level:

II. The following solutions for implementing RWD were proposed during the conference.

In regulatory framework in Russia at the national level, the following are necessary:

In the use of RWD and evidence derived from it in health technology assessment in Russia at the national level:

In the use of RWD study results in the development of clinical guidelines in Russia at the national level:

In the use of RWD and RWE in the implementation of innovative drug supply models in Russia at the national level:

In the implementation of information systems as a source of RWD:

In obtaining RWD from the analysis/maintenance of registries in Russia at the national level, the following are necessary:

Regarding the improvement of personal data protection and processing, it is necessary:

Regarding the improvement of the model for storage, management, and interoperability of medical data in the Russian Federation:

In regulatory framework at the EAEU level, it is necessary:

Recommendations for patient communities:

In organizing interdepartmental and expert interaction, it is necessary:

Experts who spoke at the conference; Association of Health Technology Assessment Specialists; Association of Clinical Pharmacologists; St. Petersburg Chapter of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).