IDEAS home Printed from https://ideas.repec.org/a/eee/socmed/v128y2015icp255-262.html
   My bibliography  Save this article

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

Author

Listed:
  • Zvonareva, Olga
  • Engel, Nora
  • Martsevich, Sergey
  • de Wert, Guido
  • Horstman, Klasien

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.

Suggested Citation

  • Zvonareva, Olga & Engel, Nora & Martsevich, Sergey & de Wert, Guido & Horstman, Klasien, 2015. "International clinical trials, cardiovascular disease and treatment options in the Russian Federation: Research and treatment in practice," Social Science & Medicine, Elsevier, vol. 128(C), pages 255-262.
  • Handle: RePEc:eee:socmed:v:128:y:2015:i:c:p:255-262
    DOI: 10.1016/j.socscimed.2015.01.038
    as

    Download full text from publisher

    File URL: http://www.sciencedirect.com/science/article/pii/S0277953615000647
    Download Restriction: Full text for ScienceDirect subscribers only

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    1. Timmermans, Stefan & McKay, Tara, 2009. "Clinical trials as treatment option: Bioethics and health care disparities in substance dependency," Social Science & Medicine, Elsevier, vol. 69(12), pages 1784-1790, December.
    2. Lidz, Charles W. & Appelbaum, Paul S. & Grisso, Thomas & Renaud, Michelle, 2004. "Therapeutic misconception and the appreciation of risks in clinical trials," Social Science & Medicine, Elsevier, vol. 58(9), pages 1689-1697, May.
    3. Hallowell, Nina & Cooke, Sarah & Crawford, Gill & Lucassen, Anneke & Parker, Michael, 2009. "Distinguishing research from clinical care in cancer genetics: Theoretical justifications and practical strategies," Social Science & Medicine, Elsevier, vol. 68(11), pages 2010-2017, June.
    Full references (including those not matched with items on IDEAS)

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:eee:socmed:v:128:y:2015:i:c:p:255-262. See general information about how to correct material in RePEc.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: (Dana Niculescu). General contact details of provider: http://www.elsevier.com/wps/find/journaldescription.cws_home/315/description#description .

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service hosted by the Research Division of the Federal Reserve Bank of St. Louis . RePEc uses bibliographic data supplied by the respective publishers.