International clinical trials, cardiovascular disease and treatment options in the Russian Federation: Research and treatment in practice. (March 2015)

• Record Type: Journal Article
• Authors: Zvonareva, Olga; Engel, Nora; Martsevich, Sergey; de Wert, Guido; Horstman, Klasien
• Is Part Of: Social science & medicine. Volume 128(2015)
• Page Start: 255
• Page End: 262
• Publication Date: 2015-03
• Subjects: Russia -- Clinical trials -- Bioethics -- Research and treatment -- Noncommunicable diseases; Social medicine -- Periodicals; Medical anthropology -- Periodicals; Public health -- Periodicals; Psychology -- Periodicals; Medicine -- Periodicals; Medicine -- Periodicals; Médecine sociale -- Périodiques; Anthropologie médicale -- Périodiques; Santé publique -- Périodiques; Psychologie -- Périodiques; Médecine -- Périodiques; Electronic journals; 362.105
• DOI: 10.1016/j.socscimed.2015.01.038
• Languages: English
• ISSNs: 0277-9536

Abstract

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. Highlights: We study the experiences of participants and investigators in CVD trials in Russia. Trials become a way to access and provide health care. Research and treatment in trials are not mutually exclusive, but mutually enabling. However, trials as healthcare option are risky as it is volatile and exclusive. Empirically grounded reflection on research/treatment interface in trials is needed.