For many reasons randomized clinical trials today can»t cope with the tasks set by modern health care, which was clearly demonstrated by the COVID-19 pandemic. This gave new impetus to the development of the RWD / RWE. It became obviously that in cases of impossibility, unethical and other reasons, new methods for obtaining high-quality evidence may be effectively used, and later can be used by decision-makers and organizations engaged in the assessment of health technologies.

Mass vaccination against pertussis in our country has decreased the frequency of this infection. The lack of the total vaccination in children in 80-90 yy XX c led to the growth of morbidity in the current moment. Return in active vaccination / revaccination of population against pertussis is a demand of the time. Economic aspects of this kind approach to the social health care are required for an evaluation based on RWD.

Materials and methods: Calculation of the macroeconomic effects of vaccination against pertussis has been performed with Far East Federal Region (FEFR) example for buster in children 6-7 y. o. based on RWD and prognosis of morbidity annually. A unique model of the epidemiology of pertussis in FEFR has been created with RWD statistics and the Global burden of diseases project usage. The size of the virtual cohort of children 6-7 y. o. was established as 100 thousand. It has been assumed that 95 % from this cohort will receive buster of the tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, combined, adsorbed (INN) with its efficacy and cost consideration. The monetary equivalent of the epidemiologic benefit due to disease prevention in the vaccinated children with regional GDP per capita has been calculated.

Results: The total summarized benefit due to illness prevention after buster in children in FEFR could be as 21,15 mln RUR annually, and due to mortality reduction in the life years expectation horizon — of 50,45 mln RUR. The total economic profit of the buster revaccination against pertussis in children 6-7 y. o. with its influence on morbidity in children of younger age groups can lead to 198,69 bln RUR during the 7-year horizon of vaccine efficacy.

Conclusion: RWD is a base for modeling and potential prognosis of epidemiological process and results of this job are proved the economic necessity for buster vaccination against pertussis in children 6-7 y. o. in the Russian Federation.

Creating a disease models based on real-world clinical data from the moment of diagnosis is an important task of the healthcare system, it allows to simulate the quantitative need for hospitalizations with various options for necessary treatment and calculate the approximate amount of necessary funding.

The study aims to build a model calculating the necessary volumes of medical care and funding for inpatient treatment of patients with lung cancer.

Materials and methods. Anonymized data from the territorial compulsory medical insurance fund and the Department of high-tech medical care for all cases of lung cancer and metastases of any localization (ICD-10: C34 and C77-78) for residents of St. Petersburg, who received medical care from 2011 to 2020. Data from the population cancer registry database for all lung cancer patients in St. Petersburg since 2000.

Results. More than 75 % of hospitalizations occur within 1 year from the moment of diagnosis: 68 % — chemotherapeutic treatment, 17 % — surgery, 3 % — radiotherapy. In the first year, 1 patient with stages I and II has an average of 2 hospitalizations, III and IV — 3. The calculated by the model number of hospitalizations in the 2 236 lung cancer patients in 5 years is 7 108. Payment for inpatient care based on the tariffs of the federal fund of 2022 and the number of newly diagnosed lung cancer diagnoses for five years will cost the healthcare system 1.1 billion RUR, and more than 74 % of this amount is the cost of 1 year of treatment. During the 5 years, surgery will cost 145 million RUR, chemotherapy — more than 898 million RUR, and radiotherapy — 37 million RUR.

Conclusion. The developed on the real-world clinical data model can be used to calculate the necessary healthcare needs and its costs.

In the review, data from foreign medical publications are presented, which are dedicated to the narcogenic potential of a strong opioid. Risk assessments of drug addiction development, of its diversification into illegal trafficking for non-medical use are given. Assessment data have a comparative character with opioids. In analyzed articles, the authors used different methodological approaches to the assessment of strong opioids narcogenicity, in particular to the evaluation of the results of population-based cohort studies, to the analysis of large databases accumulating data on different drug abuse, including opioids, data on intoxication with preparations of the group, and some others. Based on the analysis of published assessment results of potential risks of strong opioids use, the author gives the evaluation of the organization of its accountability and prescription in the Russian Federation.

The use of data and evidence from real clinical practice (RWD / RWE) is becoming more and more relevant to the healthcare system when making critical decisions in the field of drug circulation regulation, as well as making decisions on the inclusion or non-inclusion of a drug in government funding programs.

This article discusses the role of clinical registries as one of the most important sources of RWD / RWE. Definitions of terminology are given, and various types of registers are described according to the type of information collected, methods of its collection, storage, and processing. It also shows the possibility of using registers in decision-making, describes the mechanisms for consolidating information from various types of registers, as well as obtaining data for analysis from other sources, shows the importance of correct collection and validation of data collected in the register.

The article also briefly describes the local experience in the development, implementation, and maintenance of registers on the example of a number of disorders.

It was prepared using guidelines prepared by the Office of Medical Policy of the Center for Drug Evaluation and Research in collaboration with the Center for Biological Evaluation and Research and the US Food and Drug Administration»s Center of Excellence in Oncology.