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Real-World Data & Evidence

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Vol 2, No 1 (2022)
View or download the full issue PDF (Russian)

ACTUAL REVIEW 

1-9 915
Abstract

The article provides a brief overview of the main trends in the development of real-world data and real-world evidence (RWD/RWE) paradigm in the United States, Russia, and the Eurasian Economic Union (EAEU) in 2021. The review is compiled in calendar sequence. First, events in the United States are presented, sourced from the information resource, "The Evidence Base". Following this, data for the Russian Federation and the EAEU are collected and stored on the "myRWD — Real Clinical Practice" Facebook page, and in the journal "Real-World Data & Evidence". The information is summarized and a complete picture of the development of real clinical practice and its evidence in the indicated countries is given.

REGULATORY SYSTEM 

11-16 481
Abstract

The article describes the regulatory approaches to the collection, analysis and usage of real-world data applied in the European Union and Japan.

17-27 188
Abstract

The article describes the regulatory approaches to the collection, analysis and usage of real-world data applied in China.

DRUG SAFETY 

28-35 262
Abstract

According to a number of studies, medicinal plants and drugs based on them can be used as inhibitors of various viral infections, including the SARS-CoV-2 virus at different stages of their manifestation and development. In a number of countries, official recommendations have been developed for independent and auxiliary therapy of COVID-19 with medicinal plants and drugs based on them. However, in combination with drugs developed for the treatment of COVID-19, various interactions, including adverse ones, may occur.

Purpose: to systematize and analyze data on possible interactions of medicinal plants and natural biologically active substances, which are major active substances in plant raw materials, with medicinal products recommended for the treatment of COVID-19.

Materials and methods. The study selected drugs recommended for the treatment of COVID-19 at various stages and severity with different mechanisms of action. We used open information on confirmed drug interactions on the website of the international database https://go.drugbank.com/.

Results and discussion. The results of possible interactions with the following medicinal plants were revealed: St. John’s wort, Digitalis, Periwinkle, Colchicum, Cinchona, Strophant, Ergot, Pepper, Lemon, Coffee, Tea, Yohimbe tree, Garlic, Evening primrose, Poppy opium, Rauwolfia serpentine.

Conclusion. The drugs used for the treatment of COVID-19 of different anatomical and therapeutic groups are considered, possible changes in their therapeutic efficacy are identified when taken simultaneously with medicinal plants or biologically active substances of plant origin contained in food and nutritional supplements. It is shown that not all interactions may be undesirable. The effect of medicinal plants on the pharmacokinetics of drugs has not been studied enough and seems to be an important and promising aspect of pharmacovigilance activities. Interesting interactions have been identified: St. John’s wort and drugs based on it can cause the induction of CYP3A and reduce the therapeutic effect when used together with drugs: lopinavir, remdesivir, umifenovir, nirmatrelvir; the cardiotoxic effect of interferon can be reduced through the use of medicinal plant materials containing cardiac glycosides; the combination of ferulic acid with peginterferon alfa-2a increases the risk and severity of bleeding. It was found that the Drugbank database does not contain information on drug-drug interactions of medicinal plants with molnupiravir.

SOFTWARE 

36-39 258
Abstract

Visualization of research results based on data from real clinical practice (RWD) is mandatory when conducting presentations and publishing reports. One of the additional tools that allow you to customize complex reports is the business intelligence service from Microsoft Power BI. The article discusses various ways of loading, processing and visualizing data from clinical registers using the specified software.

MARKET 

40-43 170
Abstract

Real-world data (RWD) and real-world evidence (RWE) are a valuable resource in the healthcare system. They may be necessary for administrators (to create and improve algorithms for treating patients with various nosologies), physicians (to make a better clinical decision in favor of the patient) and directly to patients and their relatives (to better understand the treatment process). The creators of this data are also the physicians, patients and health care organizations. To process such a volume of data, specialized specialists are needed — mathematicians, data specialists, biostatistics, which in turn generates a service sector in the field of RWD/RWE. Depending on the component, the market is segmented into datasets and services. In 2020, the services segment held a large share — 58.8% of the global RWE solutions market. The market for these services and the data itself is growing every year and is projected to reach 2.3 billion US dollars by 2026.



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ISSN 2782-3784 (Online)