Zdravookhranenie Rossiiskoi Federatsii / Ministerstvo zdravookhraneniia RSFSR最新文献

{"title":"Mental health care for COVID-19 patients in a multidisciplinary hospital: managerial aspects","authors":"V. E. Pashkovskiy, N. Petrova, M. Sivashova, G. Prokopovich","doi":"10.47470/0044-197x-2023-67-1-29-35","DOIUrl":"https://doi.org/10.47470/0044-197x-2023-67-1-29-35","url":null,"abstract":"Introduction. COVID-19 affects not only the respiratory tract and lungs, but also the central nervous system. These organic lesions lead to the development of mental and neurological disorders. The structure of psychiatric disorders in COVID-19 is poorly understood, but the data are important for the management and planning of medical care. \u0000The purpose of the study. Analysis of the management of psychiatric care in a multidisciplinary hospital from the point of view of the algorithmization of the work of a psychiatrist and psychotherapist in the context of COVID-19. \u0000Material and methods. The relevant materials on the results of the activities of the psychiatric service of the hospital for war veterans in St. Petersburg during the coronavirus pandemic were analyzed. \u0000Results. Psychiatric and psychotherapeutic care was provided to COVID-19 patients or suspected of having the disease admitted to the hospital. As a result of a psychiatric examination, the observation mode was determined in the admissions department, the intensive care unit and the infectious diseases department. Indications for the provision of psychiatric and psychotherapeutic care and transfer to a psychiatric hospital with departments for patients with coronavirus infection have been developed. \u0000Limitations of the study. The results of this study cannot be extrapolated to the work of all multidisciplinary hospitals, because associated with the presence of a psychiatrist and a psychotherapist in the staff of the institution. A limitation can be considered the non-inclusion in the study of persons under 45 years of age. \u0000Conclusion. The experience of the psychiatric service of a multidisciplinary hospital reflects the need for the activity of the psychosomatic link in the context of the COVID-19 pandemic.","PeriodicalId":39241,"journal":{"name":"Zdravookhranenie Rossiiskoi Federatsii / Ministerstvo zdravookhraneniia RSFSR","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46625208","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The prevalence of oncological diseases among the population of the Siberia region and the Far East","authors":"L. Zhuikova, E. Choynzonov, O. Ananina, L. V. Pikalova, G. A. Kononova","doi":"10.47470/0044-197x-2023-67-1-64-71","DOIUrl":"https://doi.org/10.47470/0044-197x-2023-67-1-64-71","url":null,"abstract":"The purpose of the study was to analyze cancer incidence in Siberia and the Russian Far East in 2010–2021. \u0000Materials and methods. We used data from population-based cancer registries in 21 administrative territories of Siberia and the Russian Far East for 2010–2021. The calculations were carried out using the direct standardization method. \u0000Results. In 2021, the most common cancer sites in males were: lung (18.7%), prostate (14.1%) and colorectum (11.1%); in females: breast (21.0%), skin (12.6%) and colorectum (11.3%). From 2010 to 2019, the overall cancer incidence rate increased by 26.7%. Age-standardized incidence rates in males increased from 301.2 to 332.10/0000. For females, age-standardized incidence rates increased from 220.8 to 256.10/0000. \u0000In 2020, cancer incidence rates decreased, the overall decline was 12.9%. Age-standardized cancer incidence rates in males and females were 288.5 and 223.2 per 100 000 population, respectively. In 2021, the corresponding rates for males and females were 288.2 and 235.80/0000, respectively. \u0000Limitations. To assess the prevalence of oncological diseases in the territories of Siberia and the Russian Far East 1 233 759 new cases of malignant neoplasms were analyzed over 12 years, which is a sufficient reference sample. \u0000Conclusion. In Siberia and the Russian Far East, cancer incidence rates in 2020 were lower than in 2019 due to the COVID-19 pandemic, which led to the reduction in the number of cases diagnosed and referred for the first-line treatment. In 2021, an increase in the age-standardized cancer incidence rate was observed, with the age at diagnosis tended to be younger. In 2010, 80–84 years men and 75–79 years women exhibited the highest incidence rates (2536.5 and 1246.80/0000, respectively). In 2021, the highest cancer incidence rates for males and females were observed in the 70 to 74 years group (2717.1 and 1402.60/0000, respectively).","PeriodicalId":39241,"journal":{"name":"Zdravookhranenie Rossiiskoi Federatsii / Ministerstvo zdravookhraneniia RSFSR","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41462760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Values-based healthcare (systematic review)","authors":"O. Khodakova, Yulia V. Evstafieva, I. Deev, O. Kobyakova","doi":"10.47470/0044-197x-2023-67-1-5-13","DOIUrl":"https://doi.org/10.47470/0044-197x-2023-67-1-5-13","url":null,"abstract":"The current demographic situation is characterized by an increase in life expectancy and gain in the number of chronic non-communicable diseases. Healthcare is faced with the task of preserving the population health in these additional years of life, which, in turn, will lead to an increase in the shortage of resources in healthcare and, in general, negatively affect the economies of states. One of the modern concepts of optimal use of resources, evaluation of the effectiveness of health systems is value-based healthcare. In the described model, the value for the patient is the result of medical care in relation to health, which is important for the patient, the criteria for achieving which are determined by the patient himself. According to the concept of the Center, measuring the results and costs for each patient is part of the strategic program for the transition to a highly efficient healthcare system. \u0000The purpose of the study is to investigate the features of value-based healthcare in different countries of the world. \u0000A systematic review was conducted according to the PRISMA guidelines. \u0000The literature search was performed in the electronic databases PubMed/MEDLINE, Scopus, eLibrary, CyberLeninka, and Yandex and Google systems among English and Russian-language reports. In the healthcare systems of countries that have implemented a value-based approach, the activities of medical institutions are evaluated according to indicators that reflect the value to the patient. To combine the available resources and coordinate the provision of medical care, multidisciplinary teams of specialists are being created and the patient is provided with a full range of services without delay at all stages. In such models, all processes in medical institutions are standardized, which makes it possible to reduce losses and costs at all stages of medical care and increase the results that are valuable for patients.","PeriodicalId":39241,"journal":{"name":"Zdravookhranenie Rossiiskoi Federatsii / Ministerstvo zdravookhraneniia RSFSR","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49006053","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Relationship between mortality from diseases of the circulatory system with the consumption of alcoholic beverages","authors":"D. Loskutov","doi":"10.47470/0044-197x-2023-67-1-56-63","DOIUrl":"https://doi.org/10.47470/0044-197x-2023-67-1-56-63","url":null,"abstract":"The purpose of the study is to identify the relationship between total mortality and due to diseases of the circulatory system (CSD) with indicators of sales and consumption of alcoholic beverages in the Republic of Mari El. \u0000Material and methods. The analysis includes data from official federal and regional statistics on alcohol sales, total and CSD mortality. Alcohol consumption was calculated according to the methodological recommendations of the Russian Ministry of Health. To evaluate the time series, we calculated the coefficient of determination, the median with a 95% confidence interval, the Mann–Whitney test, and the Spearman correlation coefficient with a time lag. \u0000Results. Over 2000–2018 mortality due to CSD in the Republic of Mari El decreased, not differing from the average Russian indicator in terms of level and trend. In the region, per capita sales of alcoholic beverages (from 4.4 to 8.1 liters) were significantly lower than estimated alcohol consumption (from 10.9 to 21.3 liters). A strong relationship between CSD associated mortality was established with per capita estimated consumption of strong alcohol (r = 0.97–0.5 with a lag of 0 to 6 years) and sales of vodka per capita (r = 0.77–0.48 with a lag of 0 up to 3 years), with a high correlation among the working-age population in men (r = 0.82–0.64 with a lag of 0 to 4 years) and a long-term one in women (r = 0.72–0.48 with a lag of 0 up to 5 years). \u0000Research limitations. The study has regional (Republic of Mari El) restrictions. \u0000Conclusion. CSD associated mortality rates are statistically significantly correlated with the sale and consumption of alcoholic beverages with a delayed effect. Therefore, one of the ways to reduce mortality may be measures to reduce alcohol consumption.","PeriodicalId":39241,"journal":{"name":"Zdravookhranenie Rossiiskoi Federatsii / Ministerstvo zdravookhraneniia RSFSR","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42035987","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Colorectal cancer: analysis of morbidity and mortality in the Republic of Tatarstan","authors":"Nailya Z. Yusupova, Liliya A. Giniyatullina","doi":"10.47470/0044-197x-2023-67-1-72-77","DOIUrl":"https://doi.org/10.47470/0044-197x-2023-67-1-72-77","url":null,"abstract":"Introduction. Colorectal cancer is one of the topical cancers, the incidence of which is growing significantly. \u0000Purpose: is analysis of incidence and mortality from colorectal cancer in the Republic of Tatarstan. \u0000Material and methods. The study was conducted using data from official statistical reporting forms, linear regression, cluster analyzes. For statistical data processing there were used MS Excel and Statistica Trial 13. \u0000Results. During the studied period in the Republic of Tatarstan, there has been a tendency towards an increase in the incidence of colon cancer (R2 = 0.98) and cancer of the rectosigmoid junction, rectum and anus (R2 = 0.91). The overall gain in the incidence of colon cancer over 2018 compared to 2014 was 21.6%, an average annual increase of 6.2% (t = 12.5; p = 0.001); cancer of the rectum, rectosigmoid junction and anus — 32.4%, the average annual growth rate — 7.9% (t = 5.53; p = 0.011). Against the background of an increase in morbidity, mortality rates from CRC are relatively stable. The share of CRC in 2018 in the structure of the incidence of the population of the Republic of Tatarstan with cancer was 13.4%, in the structure of mortality — 15%. The conducted cluster analysis made it possible to identify in the territory of the Republic of Tatarstan four clusters which have statistically significant differences between the indicators of colorectal cancer incidence and mortality from it. \u0000Limitations of the study. The analysis of morbidity and mortality from CRC of the population was carried out both for the entire territory of the Republic of Tatarstan and for individual regions, for the period from 2014 to 2018, which seemed sufficient to achieve the set goal. \u0000Conclusion. In modern conditions, CRC is an actual oncological pathology, the share of which in the morbidity structure of the population of the Republic of Tatarstan cancer in 2018 was 13.4%, mortality — 15%. To change the negative trends in morbidity and mortality of the population of the Republic of Tatarstan from CRC, it is necessary to conduct research on the scale of the republic aimed at assessing the impact of various risk factors and early diagnosis of this pathology.","PeriodicalId":39241,"journal":{"name":"Zdravookhranenie Rossiiskoi Federatsii / Ministerstvo zdravookhraneniia RSFSR","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49438842","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dynamics of morbidity in the children’s population of the Krasnoyarsk Territory over 2011–2020","authors":"V. Kapitonov, Alexey Yu. Senchenko","doi":"10.47470/0044-197x-2023-67-1-49-55","DOIUrl":"https://doi.org/10.47470/0044-197x-2023-67-1-49-55","url":null,"abstract":"Introduction. The Krasnoyarsk Territory, in the Russian Federation, is second only to the Sakha Republic in terms of area. The large territory, the uneven distribution of settlements, complicate the medical care of the population and the availability of medical care, which determines the relevance of studying regional indicators of the morbidity in the child population. \u0000Purpose of the study is to analyze and evaluate the dynamics of morbidity indicators of the children’s population of the Krasnoyarsk Territory for 2011–2020. \u0000Results. A tendency to decrease the indicators of the prevalence and incidence and a gain in the previously known morbidity in 0 to 14 years children has been revealed. The trend in the general coefficients of chronization of diseases and the proportion of chronically ill children when applying to outpatient clinics increased by 1.5 and 1.6 times. High rates of the gain in chronic pathology prevalence were noted for classes of diseases of musculoskeletal system and connective tissue by 105.3%, endocrine system, nutrition and metabolic disorders — 100.0%, skin and subcutaneous tissue — 71.5%. \u0000Limitations. The study has regional (Krasnoyarsk Territory) restrictions and concerns the child population aged 0 to 14 years. \u0000Conclusion. The analysis and assessment of morbidity for 2011–2020 allowed us to determine the direction of the trend in morbidity rates and the state of health of children from 0 to 14 years. The results obtained should be taken into account in planning the provision of therapeutic and preventive care for children.","PeriodicalId":39241,"journal":{"name":"Zdravookhranenie Rossiiskoi Federatsii / Ministerstvo zdravookhraneniia RSFSR","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48313501","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lean management technologies to optimize COVID-19 vaccination \u0000in adults","authors":"T. Garifullin, M. Avdeeva, Victor P. Panov, V. Filatov, O. G. Hurtsilava, T. Z. Alikbaev","doi":"10.47470/0044-197x-2023-67-1-14-22","DOIUrl":"https://doi.org/10.47470/0044-197x-2023-67-1-14-22","url":null,"abstract":"Introduction. Lean process improvements are needed to meet the increased adult demand for COVID-19 vaccinations. \u0000The purpose of the study is to develop interventions to improve adult vaccination against COVID-19 based on lean manufacturing strategies. \u0000Material and methods. We conducted 200 timings of the COVID-19 vaccination process and surveyed 200 vaccinated people. The time of the process, the time of creation of the value stream was calculated, production losses were analyzed. \u0000Results. After optimizing the COVID-19 vaccination process, the process time decreased by 2.3 times (from 5474.3 ± 127.3 to 2354.6 ± 22.5 sec; p < 0.01). The time for the prophylactic vaccination against COVID-19 in the vaccination room was reduced by 3 times (from 600.6 ± 23.3 to 181.3 ± 25.6 sec; p < 0.01). Production losses in the form of overproduction, excessive data processing, and unnecessary movements are excluded from the activities of the doctor and the nurse at the vaccination room. The time to value stream creation during vaccination increased from 68% to 97% (p < 0.01). \u0000Limitations. The research materials are limited to the results of scientific research of the North-Western State Medical University named after I.I. Mechnikov received over 2021. \u0000Conclusion. The use of lean manufacturing technologies made it possible to identify the nature of production losses and analyze the causes of their occurrence in the process of vaccination of the adult population against COVID-19. The organizational measures taken in the form of patient flow management, standardization of work processes, redistribution of functional responsibilities, elimination of production losses contributed to a significant increase in the throughput of the vaccination room in the context of the COVID-19 pandemic.","PeriodicalId":39241,"journal":{"name":"Zdravookhranenie Rossiiskoi Federatsii / Ministerstvo zdravookhraneniia RSFSR","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47020316","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Social work as a new component in the health care system (literature review)","authors":"A. Martynenko","doi":"10.47470/0044-197x-2023-67-1-85-92","DOIUrl":"https://doi.org/10.47470/0044-197x-2023-67-1-85-92","url":null,"abstract":"Social work as a new profession and a new specialty was established in our country in 1991. Over the past 30 years, the practice of social work in various spheres of life has been developed, research directions have been formed, social education as a new field of personnel training has developed. In this process, a special place is occupied by a specialized area of social work in the health care system including medical and social work. The review presents three components: the place and role of social workers in medical institutions; directions of scientific research on this issue; features of the training of professional social workers of medical and social profile. \u0000The analysis of regulatory documents of the Ministry of Health of the Russian Federation confirms the need for social workers for the activities of medical management of psychiatric, narcological, geriatric services, palliative care and medical rehabilitation institutions. At the same time, the need for interdepartmental interaction between medical and social service institutions is emphasized. \u0000The analysis of reports concerning results of scientific research on the problems of medical and social work was performed for the entire period of the formation and development of this type of activity in the Russian Federation (1991–2022). When searching for literature, the databases of the RSCI, CyberLeninka, Google Scholar were used. \u0000Scientific research on the problems of medical and social work is shown to be conducted both on private and systemic issues within the framework of medical, social and pedagogical sciences. \u0000The content of educational training programs for social workers of the medical and social profile reflects the features that allow students forming professional competencies, the implementing willingness of students to participate in the complex solution of problems of physical, mental health and social ill-being. \u0000The materials presented in the review are of scientific and practical importance. They show that a new component is formed in the modern system of health care of the Russian Federation — professional social work as a type of activity, the carriers of which participate in the provision of medical and social assistance and the mode of social and medical services to citizens.","PeriodicalId":39241,"journal":{"name":"Zdravookhranenie Rossiiskoi Federatsii / Ministerstvo zdravookhraneniia RSFSR","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45249247","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Provision of the Russian population with inpatient ophthalmological \u0000medical care","authors":"N. S. Khodzhaev, A. D. Chuprov, A. O. Lositskiy, V. A. Trubnikov, K. Tonaeva, T. Kazakova","doi":"10.47470/0044-197x-2023-67-1-36-41","DOIUrl":"https://doi.org/10.47470/0044-197x-2023-67-1-36-41","url":null,"abstract":"Introduction. The level of provision of the population with bed resources is one of the key indicators of the availability of specialized medical care (SMC). \u0000Purpose is to study the provision of the Russian population with specialized ophthalmological medical care, depending on the incidence of eye disorders. \u0000Material and methods. The assessment of population provision with specialized ophthalmological medical care was carried out on the base of an analysis of data from federal forms of statistical reporting forms of Russian Federation regions over 2017. Statistical processing of the material included methods of descriptive statistics; calculation of average and relative values. Spearman’s rank correlation method was used to determine the correlation between quantitative variables. \u0000Results. The value of indicator of population provision with ophthalmological beds (OB) per 100 thousand of the population: the minimum — 1.8, the maximum — 55.1, the average — 11.9 beds. The average value of the number of days of an OB occupation per year in Russia is 314 ± 33. The average value of the duration of the patient’s stay in the OB is 6.5 ± 1.4 days. The average indicator value of the Russian population general morbidity with the organ of vision and its adnexa diseases is 10,462 ± 3,069 cases per 100 thousand of the population. The rank correlation coefficient of the indicators of the provision of the population with OB and the indicators of eye diseases incidence is 0.05 at p > 0.05. \u0000Limitations. The research materials are limited to the results of the analysis of data from federal forms of statistical reporting of Russian Federation regions for 2017. \u0000Conclusion. The provision of the population of the Russian Federation regions with ophthalmological beds does not correlate with the incidence rates of eye diseases (r = 0.05 at p > 0.05). For the first time, a comparative assessment of the actual provision of the population of the Russian Federation with ophthalmological beds is given in comparison with the recommended standard: 12 versus 10.7 beds per 100 thousand of the population, respectively. The number of days of occupation of an ophthalmic bed per year was found do not increase with an increase in the average time of hospitalization of an ophthalmic patient, but decreases with a certain degree of probability (r = (–0.25) at p < 0.05).","PeriodicalId":39241,"journal":{"name":"Zdravookhranenie Rossiiskoi Federatsii / Ministerstvo zdravookhraneniia RSFSR","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43739641","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative analysis of the criteria for conducting clinical trials \u0000of medicines in Russian Federation, the United States of America \u0000and the European Union","authors":"D. A. Lebedeva","doi":"10.47470/0044-197x-2023-67-1-78-84","DOIUrl":"https://doi.org/10.47470/0044-197x-2023-67-1-78-84","url":null,"abstract":"Introduction. As a part of the admissions to the market for medicines, there are requirements and restrictions that apply to the application of the “risk-based approach”. Requirements differ by subject, object of the tstudy, individual characteristics. The author carried out a comparative legal analysis of the requirements and criteria established by the legislation of the Russian Federation, USA, and EU. \u0000The purpose of the study is to identify criteria, limitations in the process of conducting clinical trials of medicines involving humans. \u0000Material and methods. The author studied the Russian legislation in the field of restrictions on clinical trials of preparations and analyzed the relevant experience of the USA and EU. Methods of structural analysis, logical generalizations, classifications, comparative legal method were used. \u0000Results. The Russian regulation of drug trials provides for a fairly wide and complete list of restrictions and requirements that contribute to the implementation of a risk-based approach. At the same time, EU and USA legislation is more focused on protecting the rights of participants under study, Russian standards must be supplemented in terms of work with minors during clinical trials. The Russian legal model of clinical trials may develop in the area of ​​liberalizing restrictions and establishing more detailed the procedure for participation in the clinical trials of certain categories of persons. \u0000Limitations. This article is compiled on the basis of 67 sources available to the author (student libraries, Russian databases of articles and journals). The study is limited to a sample of 27 sources, of which 10 are normative acts on the topic of work. \u0000Conclusion. The article develops criteria for comparing the limitations of clinical trials of medicines in the Russian Federation, USA and EU, and suggests recommendations for improving the Russian regulatory model. A transparent range of requirements for conducting clinical trials ensures the safety for the population, including certain categories of people. Russian regulation should be improved in terms of ensuring the protection of the rights of the maximum number of participants, depending on national priorities, taking into account the best foreign practices.","PeriodicalId":39241,"journal":{"name":"Zdravookhranenie Rossiiskoi Federatsii / Ministerstvo zdravookhraneniia RSFSR","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45533681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}