Introduction

On September 19, 2024, in Moscow (Russian Federation), the Association of Health Technology Assessment Specialists, the Association of Clinical Pharmacologists, and the St. Petersburg Division of the International Society for Pharmacoeconomic Research and Scientific Analysis organized and held the 5th annual scientific and practical conference with international participation "RWD/RWE. Possible and Real". The topic of the conference brought together leading specialists in the field of RWD/RWE.

A separate symposium "Digital Transformation in Medical Research: Possibilities of Data Science, AI and Engineering Approaches in RWE" was held within the framework of the V conference.

The conference participants discussed tools for researching RWD/RWE, the growing importance of RWE in modern medicine, legislation, as well as global prospects in the world, Russian Federation and the EAEU. A total of 28 reports were presented at the conference.

We invite you to familiarize yourself with the Conference Resolution.

RESOLUTION

This Resolution based on the results of the V annual scientific and practical conference with international participation "RWD/RWE. Possible and Real", which occurred on September 19, 2024, Moscow (Russian Federation).

The conference participants noted the significant progress made since the previous meetings. Thus, within the framework of the EAEU working group, a group of experts developed a whole series of guidelines (roadmap) for the EAEU in the field of collecting, analyzing and using RWD, and Order of the EEC Board No. 155, "General approaches to the development of regulation of the circulation of medicines within the Eurasian Economic Union in terms of collecting, analyzing and using RWD" were adopted.

At the same time, the state, the expert community, public organizations, and the industry are faced with a number of systemic issues that require urgent solutions, which were brought up for discussion by the conference participants.

During the conference, the following limitations were identified for the implementation of RWD/RWE obtained on their basis:

Legal framework in Russia at the national level:

Using RWD/RWE in assessing health technologies in Russia at the national level:

Using RWD/RWE in the development of clinical guidelines in Russia at the national level:

Using RWD/RWE in the implementation of innovative models of drug provision in Russia at the national level:

Using patient-reported outcome data:

When implementing information systems as a source of RWD in Russia at the national level:

Obtain RWD from registers in Russia at the national level:

Protection and processing of personal data:

Legal framework at the EAEU level:

During the conference, the following solutions were proposed for the implementation of the RWD/RWE:

Legal framework in Russia at the national level, it is necessary to:

Using RWD/RWE was based on the assessment of healthcare technologies in Russia at the national level:

Using real-world study results in the development of clinical guidelines in Russia at the national level:

Using RWD/RWE when implementing innovative drug provision models in Russia at the national level:

When receiving RWD during the operation of information systems in the healthcare sector in Russia at the national level:

Use of patient-reported health and outcome data:

When implementing information systems as a source of RWD:

When receiving real-world data during the analysis/maintenance of registers in Russia at the national level:

To improve the protection and processing of personal data:

Legal framework at the EAEU level:

Recommendations for patient communities:

Organizing interdepartmental and expert interaction:

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19.09.2024, Moscow, Russian Federation