In March 2022, the EAEC Council approved the definitions of real-world data (RWD) and real-world evidence (RWE). ECE is now developing a concept and recommendations for the collection and analysis of such data.

The working group on the formation of common approaches to the regulation of the circulation of medicines within the Eurasian Economic Union approved the draft Concept for the Development of Approaches to the Collection, Analysis and Use of Real-World Data in the EAEU Member States. This was reported by one of the developers of the concept, head. Department of Clinical Pharmacology and Evidence-Based Medicine, First St. Petersburg State Medical University. acad. I.P. Pavlova Alexei Kolbin.

The definitions of RWD and RWE were fixed in March by the Decision of the EEC Council No. 36 dated March 17, 2022 “On Amendments to the Rules for Registration and Examination of Medicinal Products for Medical Use”.

Real-World Data (RWD) - Data related to a patient's health status and/or the healthcare process obtained from a variety of sources.

Real-World Evidence (RWE) is clinical evidence about the use and potential benefit or risk of using a medicinal product based on the collection and analysis of real-life clinical practice data.

As Kolbin said, there are no unified approaches to the collection and analysis of RWD/RWE all over the world. So far, regulators in different countries offer different methodologies and solutions. The concept prepared within the framework of the Eurasian Union includes the generalized experience of different countries and continents - South America, USA, China, Japan, European Union.

“The development of the concept involved a number of experts in scientific and practical fields studying the life cycle of drugs, the academic environment, teachers of higher educational institutions, several professional associations, primarily the Association of Health Technology Assessment Specialists and the Association of Clinical Pharmacologists,” Kolbin said. The Ministry of Health of Russia actively supported the work and gave recommendations and suggestions, the expert specified.

The decision to create the concept was made a year ago, in August 2021. Already in March of this year, the first draft of the concept was submitted for approval to some experts and organizations, including the Ministry of Health of Russia, after which, in early June 2022, the draft concept was submitted to the EEC working group. It was approved by representatives of all five EAEU countries.

According to Kolbin, the document will still be finalized, but the changes will be more of a technical and stylistic nature. The draft must also be submitted for public comment. The EEC press service also clarified that the concept would be considered again within the framework of the working group, then the document would be published for public discussion and only then considered by the EEC Board.

In addition to the concept, separate recommendations are also being developed in the EAEU, the expert said. “They will certainly be conceptual, but will include more applied information and describe standard operating procedures for conducting and analyzing real-world data. There will be several recommendations, the first two will most likely be discussed by the beginning of September 2022,” Kolbin said.

Source: https://pharmvestnik.ru/content/news/V-EEK-odobrili-proekt-koncepcii-ispolzovaniya-dannyh-realnoi-klinicheskoi-praktiki.html