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Zvonareva O.,Maastricht University | Engel N.,Maastricht University | Martsevich S.,The National Research Center for Preventive Medicine | de Wert G.,Maastricht University | Horstman K.,Maastricht University
Social Science and Medicine | Year: 2015

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. © 2015 Elsevier Ltd.

Silina E.V.,Moscow State University | Stupin V.A.,Russian National Research Medical University | Kolesnikova E.A.,RAS Research Center Kurchatov Institute | Rumyantseva S.A.,Russian National Research Medical University | Oganov R.G.,The National Research Center for Preventive Medicine
Biology and Medicine | Year: 2014

The paper presents an analysis of methods for measuring blood pressure, as well as the latest global development of invasive techniques describing their positive and negative aspects. We have described a prototype of device and multiparametric biosensor that measures systolic and diastolic blood pressure, heart rate and its variability, pulse wave velocity, i.e., indicators that characterize the work of the heart and blood vessels. Invasive microsensor is implanted in the vessel; hence, the risk of any intravascular complications is eliminated. A device is able to transmit information about the state of the cardiovascular system of the person in a real-time mode. In case of critical changes warning, signals of different levels demonstrate the need for medical care. Information about critical changes may come in the appropriate healthcare facilities, e.g., in the nearest ambulance. It is assumed that the device will help to reduce the burden of noncommunicable diseases (morbidity and mortality of the working population).

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