International clinical trials, cardiovascular disease and treatment options in the Russian Federation: Research and treatment in practice

Zvonareva, Olga; Engel, Nora; Martsevich, S. Yu.; Wert, Guido de; Horstman, Klasien

doi:10.1016/j.socscimed.2015.01.038

Cited by 3 publications

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“…38 However, the reliance on clinical research for healthcare provision is risky both because of the potential conflicts between research and treatment and also because this option is volatile and exclusive. 39 Taking account of the fact that globalizing clinical trial conduct is proceeding amidst profound health inequalities, more research is needed into the dynamics of trial participation in various settings to inform responsive and nuanced policy-making as well as more effort in ensuring accessibility of basic health care.…”

Section: Discussionmentioning

confidence: 99%

Risks and benefits of trial participation: A qualitative study of participants’ perspectives in Russia

et al. 2015

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Section: Discussionmentioning

confidence: 99%

Risks and benefits of trial participation: A qualitative study of participants’ perspectives in Russia

et al. 2015

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“…По данным мировой литературы мотивы пациентов для участия пациентов в КИ можно разделить на 4 основные группы [12][13][14] [16]. Однако число пациентов с высшим образованием, по данным нашего исследования, в 2 раза превышает показатели среди населения Российской Федерации [17]. Это может свидетельствовать о том, что высокая образованность человека напрямую связана с сознательным отношением к своему здоровью и способностью увидеть преимущества от участия в КИ.…”

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TRUST Study: Participation in Randomized Controlled Trials and Subsequent Adherence to Visiting Medical Institutions and Taking Medications in Patients with Cardiovascular Diseases. Part I. Motives for the Patients' Participation in Clinical Trials

Martsevich

Vasyukova

Кутишенко

et al. 2019

Racionalʹnaâ farmakoterapiâ v kardiologii

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Aim. To describe the design of TRUST study (Influence of Participation in Randomized Controlled Trials on adheRence to Medicines' Intake and regUlar viSits to the docTor) and present the first part of this study to determine the motives of patient participation in clinical trials.Material and methods. The main group of TRUST study included patients of the outpatient registrar PROFILE, which were taking part in one or more international randomized clinical trials, conducted from 2011 to 2018. The standard registration card of PROFILE register was used to assess the clinical and demographic data of patients.In 2019 full-time/telephone contact with patients was established, during which, based on the original questionnaire, the motives of the participation in trials, their attitude towards randomized controlled trials (RCT), and their adherence to monitoring in medical institutions were determined. This publication presents the results of the first part of the study.Results. 102 patients were enrolled in the study, telephone /personal contact was established for 88 patients, the life status of 9 of them by 2019 was defined as "dead", 77 were interviewed, 2 – refused to answer. Over 80% of patients completed participation in RCTs more than one year ago. 71.6% of patients participated in more than one RCT. In 60% of cases, patients claimed that this was the proposal of the doctor of the scientific center. For 79% of patients, RCTs had the opportunity to access highly skilled medical care. Only 18% of patients indicated that they received the necessary qualified medical care before entering the study. In cases where patients answered dichotomous questions (such as "yes"/"no"), the overwhelming majority of patients (74%) claimed that it was the authority of the doctor of the scientific center and the fear of losing the possibility of further observation became the main reason for participating in RCTs.Conclusion. In the first part of the TRUST study, it was revealed that in Russia the main reason of participation in RCT is the recommendation of a doctor from a specialized scientific center.

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(Re)configuring research value: international commercial clinical trials in the Russian Federation

et al. 2017

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International clinical trials, cardiovascular disease and treatment options in the Russian Federation: Research and treatment in practice

Cited by 3 publications

References 35 publications

Risks and benefits of trial participation: A qualitative study of participants’ perspectives in Russia

Risks and benefits of trial participation: A qualitative study of participants’ perspectives in Russia

TRUST Study: Participation in Randomized Controlled Trials and Subsequent Adherence to Visiting Medical Institutions and Taking Medications in Patients with Cardiovascular Diseases. Part I. Motives for the Patients' Participation in Clinical Trials

(Re)configuring research value: international commercial clinical trials in the Russian Federation

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