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Author Zvonareva, Olga ♦ Engel, Nora ♦ Martsevich, Sergey ♦ de Wert, Guido ♦ Horstman, Klasien
Source World Health Organization (WHO)-Global Index Medicus
Content type Text
Publisher Elsevier
File Format HTM / HTML
Language English
Difficulty Level Medium
Subject Domain (in DDC) Social sciences ♦ Sociology & anthropology ♦ Natural sciences & mathematics ♦ Life sciences; biology ♦ Natural history of organisms ♦ Technology ♦ Medicine & health ♦ Diseases ♦ Manufacture for specific uses ♦ Precision instruments & other devices
Subject Domain (in MeSH) Eukaryota ♦ Organisms ♦ Cardiovascular Diseases ♦ Diseases ♦ Investigative Techniques ♦ Analytical, Diagnostic and Therapeutic Techniques and Equipment ♦ Social Sciences ♦ Anthropology, Education, Sociology and Social Phenomena ♦ Geographic Locations ♦ Geographic Locations
Subject Keyword Discipline Medicine ♦ Cardiovascular Diseases ♦ Therapy ♦ Clinical Trials As Topic ♦ Humans ♦ International Cooperation ♦ Research Design ♦ Russia ♦ Journal Article
Abstract The issue of balance between research and treatment in clinical trials conduct has been surrounded by controversies. Scientific characteristics of trials may compromise medical care available to participants, while conceiving research participation as having therapeutic value may foster the therapeutic misconception. However, it has also been questioned whether research can and should always be separated from medical care provision. In this paper we analyze how these concerns played out in practice settings of the three trial sites in Russia, specialized in trials in cardiovascular diseases. Using in-depth interviews with participants of phase II and III trials (n = 21) and discussions with physician-investigators (n = 7), we found that trial enrollment allowed participants to establish continuous supportive relationships with the physician-investigators. In the context of unresponsive health care, chronically ill participants received regular monitoring, treatment recommendations and help in case of problems and emergencies through such relationships. The trial designs in the three sites did not preclude the provision of individualized treatment. We suggest that debates about the research/treatment interface in trials need to become more attuned to the conditions in locations of their conduct, views and experiences of actors involved and evolving trial methodologies. Too much focus on categorical differentiation of research and treatment may obscure the fact that globalizing clinical trials proceed amidst profound health disparities, dismiss diverse concerns of people on the ground and risk attenuating responsibilities of trial organizers, sponsors and investigators towards research participants.
Spatial Coverage Russia
Description Author Affiliation: Zvonareva O ( Department of Health, Ethics and Society, Maastricht University, The Netherlands. Electronic address: o.zvonareva@maastrichtuniversity.nl.); Engel N ( Department of Health, Ethics and Society, Maastricht University, The Netherlands.); Martsevich S ( Department of Preventive Pharmacotherapy, The National Research Center for Preventive Medicine, Russian Federation.); de Wert G ( Department of Health, Ethics and Society, Maastricht University, The Netherlands.); Horstman K ( Department of Health, Ethics and Society, Maastricht University, The Netherlands.)
ISSN 02779536
Educational Role Student ♦ Teacher
Age Range above 22 year
Educational Use Reading ♦ Research ♦ Self Learning
Interactivity Type Expositive
Education Level UG and PG
Learning Resource Type Article
Publisher Date 2015-03-01
Publisher Place Great Britain (UK)
e-ISSN 18735347
Journal Social Science & Medicine
Volume Number 128


Source: WHO-Global Index Medicus