Russian President Vladimir Putin signed Federal Law No. 331-FZ dated 02.07.2021 "On Amendments to Certain Legislative Acts of the Russian Federation in Connection with the Adoption of the Federal Law" On Experimental Legal Regimes in the Sphere of Digital Innovations in the Russian Federation". The real-world evidence (RWE) research project based on anonymized data from electronic health records "Date MATRIX" is one of the seven reviewed EPR participants and the only one in the Real World Evidence area.

Under the EPR, the government allows the company to comply with applicable laws with a number of features set out in the EPR program. Such features provide for the processing of personal data exclusively in anonymized form. An experimental legal regime will provide pharmaceutical and biotech companies with a legally compliant RWD provider and the ability to conduct RWE research on Russian data.

Excerpt from Federal Law No. 258-FZ of July 31, 2020 "On Experimental Legal Regimes in the Field of Digital Innovation in the Russian Federation":

“Research on real-world evidence (RWE) is widely used abroad and is a fundamental approach both in terms of accumulating scientific and medical data and in terms of forming a comprehensive assessment of diagnostic methods, drug and non-drug treatment, prevention and rehabilitation. The use of research results allows evaluating and optimizing clinical guidelines and standards of care to improve their clinical and economic efficiency, as well as within the framework of pharmacological surveillance activities. "

In the near future, Date MATRIX will demonstrate an innovative predictive data analysis tool. It is one of many products that can be created using validated data from routine clinical practice. The tool allows you to estimate survival to progression within 5 years based on the individual parameters of the patient, his disease and the performed or planned treatment, as well as compare with the best treatment option for patients with the same baseline data.

The first EPR in the world was installed in the UK in 2014. Basically, the first wave of experimental regimes focused on the financial industry and cryptocurrency regulation. Research into routine clinical practice uses a variety of sophisticated mathematical analysis methods and machine learning algorithms. The pharmaceutical industry and global regulators pin great hopes on the opportunities that EPR opens up for research of routine clinical practice and for the development of the industry, especially in such a difficult time for mankind, the company stressed.

Source: https://pharmvestnik.ru/