Background: Previous social science research has shown how some healthy phase I trial participants identify themselves as workers and rely on trials as a major source of income. The term “professionalization” has been used to denote this phenomenon. Purpose: We aim to examine a component of healthy trial participants’ professionalization that has not yet been systematically studied: how repeat phase I trial participants develop and claim expertise that distinguishes them from others and makes them uniquely positioned to perform high-quality clinical trial labor. We also aim to explain the significance of these research results for protection of healthy participants in phase I trials. Methods: This qualitative exploratory study was conducted in Russia, in two phase I trial units. It involved semi-structured interviews with 28 healthy trial participants with varying lengths of experience in trials, observations of work done in trial units, and interpretive conversations with investigative staff. Results: Interviewed healthy individuals who repeatedly participate in phase I trials describe developing knowledge and skills that involve appreciating the meaning of trial procedures, coming up with techniques to efficiently follow them, organizing themselves and others in the course of a trial, and sharing tacit ways of doing trial work well with other less experienced participants. Our results suggest that a prerequisite for such expertise-centered professionalization is the emergence of a positive identity linked to seeing value in trial participation work. A crucial component of professionalization thus understood is the development of a work ethic that entails caring about results and being reliable partners for investigators. Limitations: The attitudes and behaviors presented in this article are not suggested to be universally shared among healthy trial participants, but rather represent a particular instance of professionalization that coexists with other views and tactics. Conclusions: A way of better protecting healthy trial participants begins with recognizing their skills, knowledge, and the centrality of the contribution they are making to pharmaceutical research. Currently, the expertise of experienced trial participants is recognized on the work floor only; therefore, the professionalization we described is informal. Yet, the informal professionalization process is inherently risky as it does not involve any change in the formal conditions of trial participants’ work. Instituting formal measures for protecting healthy trial participants as skilled workers combined with recognition of their expertise is essential.

Цель исследования. Установить распространенность основных факторов риска (ФР) хронических неинфекционных заболеваний (ХНИЗ) среди студентов-первокурсников города Томска. Материал и методы. Проведено обследование 978 студентов первого курса, средний возраст составил 18,6±1,1 лет. Оценивались параметры поведенческих (табакокурение, употребление алкоголя, нерациональное питание, низкая физическая активность) и метаболических (гиперхолестеринемия, гипергликемия, артериальная гипертензия, избыточная масса тела/ожирение) ФР ХНИЗ. Результаты. Распространенность таких поведенческих ФР, как злоупотребление алкоголем и нерациональное питание, среди студентовпервокурсников Томска сопоставима с общероссийскими показателями. В сравнении с другими регионами Российской Федерации, среди первокурсников Томска табакокурение встречается чаще, причем с отсутствием гендерных различий, а низкая физическая активность-реже. Выявлено, что распространенность поведенческих ФР среди обучающейся молодежи существенно превышает общепопуляционные показатели. Так, же установлено, что метаболические ФР среди студентов первых курсов Томска остаются на более низком, чем в общей популяции, уровне, а их распространенность существенно не отличается от общероссийских показателей. Самый распространенный метаболический ФР среди обследованных лиц-избыточная масса тела, реже встречаются артериальная гипертензия, гиперхолестеринемия и гипергликемия. Наряду с высокой распространенностью ФР ХНИЗ, у студентов-первокурсников выявлен низкий уровень профилактических знаний. Заключение. Для студентов-первокурсников г. Томска выявлена необходимость создания и внедрения региональной программы первичной профилактики прежде всего употребления алкоголя и табакокурения, а также нерационального питания и гиподинамии. Ключевые слова: первокурсники, неинфекционные заболевания, поведенческие факторы риска, метаболические факторы риска, распространенность, первичная профилактика. Конфликт интересов. Авторы декларируют отсутствие явных и потенциальных конфликтов интересов, связанных с публикацией настоящей статьи.

Введение. В настоящее время клинические исследования (КИ) остаются единственной технологией, обеспечивающей доказательство эффективности и безопасности новых лекарственных средств и последующего их выхода на рынок. Врач-исследователь и информированное согласие (ИС) являются основными (и часто единственными) источниками информации для пациента о предстоящем КИ и тем самым непосредственно влияют на восприятие КИ и на решение пациента об участии. Однако до сих пор остается неясной степень влияния данных факторов на участников КИ. Материал и методы. В исследовании приняли участие девять центров, расположенных в разных городах Российской Федерации. Основным методом исследования являлось анкетирование пациентов. В рамках исследования пациенту, имеющему опыт участия в КИ и удовлетворяющему критериям отбора, однократно было предложено самостоятельно заполнить вопросник. Результаты. Для оценки влияния врача-исследователя все респонденты были поделены на две группы: пациенты, знакомившиеся с ИС совместно с врачом и самостоятельно. Самыми важными факторами,

In the review, the results provided of clinical and epidemiological trials confirming high prevalence of the risk factors of chronic noncommunicable diseases among medical workers, common comorbidity and hence adverse influence on the health. Analysis of literature data underscores the necessity of further long term populational studies of epidemiology, age range, relation to occupation positions, for the main risk factors. Organization of various preventive events is required, that obviously will impact not only health state and life quality, but furthermore, will increase medical care in general.

Introduction. Clinical trials (CTs) are the footing foundation of evidence-based medicine. In Russia many aspects of CT implementation remain unexplored; one of them is the attitude of Russian society. Aims. This study aims to determine the knowledge and perception of CTs by potential participants. Analysis of the perception of CTs through the eyes of patients: CTs - is it a benefit or an unjustified risk? Materials. The primary method of research was a questionnaire. A total of 488 anonymous, voluntary surveys of patients from hospitals in Tomsk were studied. Results. More than half of the respondents heard about CTs, while the primary source of information was the media. The participants adequately assess the importance of conducting CTs to develop medicine and medical care for society. The primary goal of CTs is to determine the effectiveness and safety of drugs, and respondents regard their engagement as an opportunity to contribute to the development of science. The primary motivating factor in participating in CTs is receiving treatment for an incurable disease and observing conditions by a qualified doctor. The central negative aspect is the possibility of causing a risk to own health. The questionnaire demonstrated the need and importance of all points of informed consent. Several questions concerned the public attitude to researchers. According to patients, medical researchers arouse trust and confidence in altruistic motives during the CTs. Conclusion. This study revealed a low interest of Russians in participating in CTs, except for personal benefit. The behavior of the doctors, the ability to convey reliable information to the patient to adequately assess benefits and possible risks play an important role in deciding on the involvement of patients in the CTs. The results of this work will allow us to adapt the process of organizing CTs to the needs of patients in the local context.

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Objectives. This work aims to provide retrospective analysis of socio-economic, demographic and clinical features of patients with HIV infection in 5 regions of Russian Federation with high prevalence of HIV infection (Krasnoyarsk, Tomsk, Irkutsk, Ulyanovsk Region, Samara Region). Materials and methods. A study was a part of the project «Natural and Clinical Course of HIV Infection in the Russian Federation». The protocol of study included a retrospective analysis of the regional Centers for the Prevention and Control of AIDS registers and medical records of patients. Inclusion criteria was a verified diagnosis of HIV infection. Diagnosis should be made by 01/01/2015 at the latest.Results. Demographic and socio-epidemiological parameters, clinical manifestations, immunological aspects and the status of antiretroviral therapy in the studied cohort were evaluated. The results of the analytical study allowed us to present a modern profile of the HIV-infected population.Discussion. The analysis showed the prevalence of socially adapted people of working age (30–39 years), the predominance of the parenteral route of HIV infection associated with intravenous drug use in men and the activation of the sexual route of HIV infection in a cohort of women, and other features of HIV epidemiology. Results of analytical work reflect the situation of HIV infection in the Russian Federation, justifying the need for further research in this area and implementing effective prevention strategies into practice.