Skip to main content
SpringerLink
Log in

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

  • Original Article
  • Published:
BioSocieties Aims and scope Submit manuscript

Abstract

Clinical trials of new drugs are generally understood in terms of contribution to the future well-being of patients and society at large, while studies of the political economy of trials reveal that global health inequalities have come to sustain the continuous and lucrative operation of this enterprise. The divide between profit generation and improvements in local well-being could be especially vivid when international commercial clinical trials are conducted in new, non-traditional locations outside of North America and Western Europe. This article focuses on how this divide is managed in the everyday work of conducting trials in a research centre in Russia. It explores how investigators and research participants engage in the work of translating trials into academic capacity-building, development of local medical expertise and provision of public health benefits. That is, research value is being multiply configured in clinical, scientific and economic domains. We view the conduct of clinical trials as a boundary process which, through enabling multiplication of value, bridges the realms of health and wealth. This reading of the process of conducting trials opens up opportunities to think about ways to maximise the value of medical experimentation and to (re)link clinical research and public good.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

Notes

  1. All interviews were conducted in Russian and then translated to English by OZ.

  2. By the beginning of 1990s the Soviet health care system was already experiencing difficulties related, among other things, to lack of funding, outdated equipment and unresponsive planning. However, when the USSR ceased to exist, the system, already loaded with problems, rapidly deteriorated even further.

  3. State funded free health care is provided in Russian cities mainly through polyclinics. These are primary care outpatient facilities where general practitioners and other medical specialists, including cardiologists, are housed. Other elements of the state healthcare system include specialised outpatient centres and hospitals of various types.

  4. The ‘press-lunch’ was organised by the Association “Innovative Pharma” (inpharma.info). A list of press releases can be found at: inpharma.info/resursy/spravochnaya-informatsiya/

  5. The article published in the electronic professional journal www.pharmvestnik.ru was based on an interview with Vladimir Gurdus, CEO of RMI Partners, Management Company of RusnanoMedInvest LLC and NovaMedica LLC.

References

  • ACTO (Association of Clinical Trials Organisations) (2015) ACTO Newsletter #10: Summary of 2014 results. Moscow. http://acto-russia.org/files/ACTO_Newsletter_10.pdf, accessed 30 September 2015.

  • Anderson, J.A. (2010) Clinical research in context: Reexamining the distinction between research and practice. The Journal of medicine and philosophy 35(1): 46–63.

    Article  Google Scholar 

  • Anokina, A. and Meshkov, D. (2007) Going further east in CEE. International Clinical Trials (Summer): 24–29.

  • Appelbaum, P.S. (2010) Clarifying the ethics of clinical research: A path toward avoiding the therapeutic misconception. American Journal of Bioethics 2(2): 22–23.

    Article  Google Scholar 

  • Appelbaum, P.S., Lidz, C.W. and Grisso, T. (2004) Therapeutic misconception in clinical research: Frequency and risk factors. IRB 26(2): 1–8.

    Article  Google Scholar 

  • Babayan, E.A. and Ytkin, O.B. (1982) General principles of assessment of medicines in USSR and other countries/Бабаян Э.А. и Уткин О.Б. (1982) Основные положения апробации лекарственных средств в СССР и зарубежных странах. М: Медицина.

  • Balázs, K., Faulkner, W. and Schimank, U. (1995) Transformation of the research systems of post-communist central and eastern Europe: An introduction. Social Studies of Science 25(4): 613–632.

    Article  Google Scholar 

  • Belmont Report (1979) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, hhs.gov/ohrp/humansubjects/guidance/belmont.html.

  • Benatar, S.R. (2004) Towards progress in resolving dilemmas in international research ethics. The Journal of Law, Medicine & Ethics 32(4): 574–582.

    Article  Google Scholar 

  • Benatar, S.R. and Fleisher, T.E. (2007) Ethical issues in research in low-income countries. International Journal of Tuberculosis & Lung Disease 11(6): 617–623.

    Google Scholar 

  • Brown, J.V. and Rusinova, N.L. (1997) Russian medical care in the 1990s: A user’s perspective. Social Science & Medicine 45(8): 1265–1276.

    Article  Google Scholar 

  • Clarke, A.E. and Star, S.L. (2008) The social worlds framework: A theory/methods package. In: E.J. Hackett, O. Amsterdamska, M. Lynch and J. Wajcman (eds.) The Handbook of Science and Technology Studies. Cambridge, MA: MIT Press, pp. 113–139.

    Google Scholar 

  • Cooper, M. (2008) Experimental labour – offshoring clinical trials to China. East Asian Science, Technology and Society: An International Journal 2(1): 73–92.

    Google Scholar 

  • de Melo-Martín, I. and Ho, A. (2008) Beyond informed consent: The therapeutic misconception and trust. Journal of medical ethics 34(3): 202–205.

    Article  Google Scholar 

  • de Vries, M.C. et al (2011) Ethical issues at the interface of clinical care and research practice in pediatric oncology: A narrative review of parents’ and physicians' experiences. BMC medical ethics 12(18), www.biomedcentral.com/1472-6939/12/18.

  • Dumit, J. (2012) Drugs for Life: How Pharmaceutical Companies Define Our Health. Durham: Duke University Press.

    Book  Google Scholar 

  • Easter, M.M., Henderson, G.E., Davis, A.M., Churchill, L.R. and King, N.M.P. (2006) The many meanings of care in clinical research. Sociology of Health & Illness 28(6): 695–712.

    Article  Google Scholar 

  • Emanuel, E.J., Wendler, D., Killen, J. and Grady, C. (2004) What makes clinical research in developing countries ethical? The benchmarks of ethical research. The Journal of infectious diseases 189(5): 930–937.

    Article  Google Scholar 

  • Epstein, S. (1996) Impure Science: AIDS, Activism and the Politics of Knowledge. Berkeley, CA: University of California Press.

    Google Scholar 

  • Fairhead, J., Leach, M. and Small, M. (2006) Public engagement with science? Local understandings of a vaccine trial in the Gambia. Journal of biosocial science 38(1): 103–116.

    Article  Google Scholar 

  • Fisher, J.A. (2009) Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials. New Brunswick, NJ: Rutgers University Press.

    Google Scholar 

  • Fisher, J.A. (2015) “Ready-to-recruit” or “ready-to-consent” populations? Informed consent and the limits of subject autonomy. In: S. Sismondo and J.A. Green (eds.) The Pharmaceutical Studies Reader. Wiley-Blackwell, pp. 195–207.

    Google Scholar 

  • Fujimura, J.H. (1992) Crafting science: Standardized packages, boundary objects, and “translation”. In: A. Pickering (ed.) Science as Practice and Culture. Chicago, IL: University of Chicago Press, pp. 168–211.

    Google Scholar 

  • Gabe, J., Williams, S., Martin, P. and Coveney, C. (2015) Intoruction: Pharmaceuticals and society: Power, promises and prospects. Social Science & Medicine 131: 193–198.

    Article  Google Scholar 

  • Gaponenko, N. (1995) Transformation of the research system in a transitional society: The case of Russia. Social Studies of Science 25(4): 685–703.

    Article  Google Scholar 

  • Geissler, P.W. and Pool, R. (2006) Editorial: Popular concerns about medical research projects in sub-Saharan Africa – a critical voice in debates about medical research ethics. Tropical Medicine & International Health 11(7): 975–982.

    Article  Google Scholar 

  • Geissler, P.W., Kelly, A., Imoukhuede, B. and Pool, R. (2008) “He is now like a brother, I can even give him some blood” – relational ethics and material exchanges in a malaria vaccine “trial community” in The Gambia. Social science & medicine 67(5): 696–707.

    Article  Google Scholar 

  • Gikonyo, C., Bejon, P., Marsh, V. and Molyneux, S. (2008) Taking social relationships seriously: Lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast. Social Science & Medicine 67(5): 708–720.

    Article  Google Scholar 

  • Hallowell, N., Cooke, S., Crawford, G., Lucassen, A. and Parker, M. (2009) Distinguishing research from clinical care in cancer genetics: Theoretical justifications and practical strategies. Social science & medicine 68(11): 2010–2017.

    Article  Google Scholar 

  • Heaven, B. (2010) Bridging the ontological divide: Different social worlds in the conduct of a pilot study. In: T. Moreira and C. Will (eds.) Medical Proofs, Social Experiments: Clinical Trials in Shifting Contexts. Farnham: Ashgate Publishing, pp. 39–47.

    Google Scholar 

  • Jespersen, A.P., Bønnelycke, J. and Eriksen, H.H. (2014) Careful science? Bodywork and care practices in randomised clinical trials. Sociology of Health & Illness 36(5): 655–669.

    Article  Google Scholar 

  • Kelly, A.H., Ameh, D., Majambere, S., Lindsay, S. and Pinder, M. (2010) “Like sugar and honey”: The embedded ethics of a larval control project in The Gambia. Social science & medicine 70(12): 1912–1919.

    Article  Google Scholar 

  • Kelly, A.H. and Geissler, P.W. (eds.) (2012) Investigating the ethics and economics of medical experimentation. In: The Value of Transnational Medical Research: Labour, Participation and Care. London: Routledge, pp. 1–12.

    Google Scholar 

  • Kimmelman, J. (2007) The therapeutic misconception at 25: Treatment, research and confusion. Hastings Center Report 37(7): 36–42.

    Article  Google Scholar 

  • Lairumbi, G.M. et al (2008) Promoting the social value of research in Kenya: Examining the practical aspects of collaborative partnerships using an ethical framework. Social science & medicine 67(5): 734–747.

    Article  Google Scholar 

  • Lakoff, A. (2004) The anxieties of globalization: Antidepressant sales and economic crisis in Argentina. Social Studies Of Science 32(2): 247–269.

    Article  Google Scholar 

  • Law, J. (2006) Big Pharma: How the World’s Biggest Drug Companies Control Illness. London: Constable & Robinson Ltd.

    Google Scholar 

  • Markina, N. (2013) In case electronic registration does not work, complain to the Ministry of Health/Маркина, Н. (2013) Если не работает электронная запись, жалуйтесь в Минздрав. Газета.ru. http://www.gazeta.ru/health/2013/07/12_a_5425073.shtml.

  • Marsh, V., Kamuya, D., Rowa, Y., Gikonyo, C. and Molyneux, S. (2008) Beginning community engagement at a busy biomedical research programme: Experiences from the KEMRI CGMRC-wellcome trust research programme, Kilifi, Kenya. Social Science & Medicine 67(5): 721–733.

    Article  Google Scholar 

  • Miller, F.G. (2004) Research ethics and misguided moral intuition. Journal of Law, Medicine and Ethics 32(1): 111–116.

    Article  Google Scholar 

  • Molyneux, S. and Geissler, P.W. (2008) Ethics and the ethnography of medical research in Africa. Social Science & Medicine 67(5): 685–695.

    Article  Google Scholar 

  • Morreim, E.H. (2005) The clinical investigator as fiduciary: Discarding a misguided idea. The Journal of Law, Medicine & Ethics : A Journal of the American Society of Law, Medicine & Ethics 33(3): 586–598.

    Article  Google Scholar 

  • Moynihan, R., Heath, I. and Henry, D. (2002) Selling sickness: The pharmaceutical industry and disease mongering. British Medical Journal 324(7342): 886–891.

    Article  Google Scholar 

  • Nguyen, V. (2010) The Republic of Therapy: Triage and Sovereignty in West Africa’s Time of AIDS. London: Duke University Press.

    Book  Google Scholar 

  • Petryna, A. (2005) Ethical variability: Drug development and globalizing clinical trials. American Ethnologist 32(2): 183–197.

    Article  Google Scholar 

  • Petryna, A. (2009) When Experiments Travel: Clinical Trials and the Global Search for Human Subjects. Princeton, NJ: Princeton University Press.

    Book  Google Scholar 

  • Petryna, A. (2015) Clinical trials offshored: On private sector science and public health. In: S. Sismondo and J.A. Green (eds.) The Pharmaceutical Studies Reader. West Sussex: Wiley-Blackwell, pp. 208–221.

    Google Scholar 

  • Pharmvestnik (2013) Vladimir Gurdus: There are conditions for innovation development in Russia. May 28.

  • Schecter, K. (1992) Soviet socialized medicine and the right to health care in a changing Soviet Union. Human Rights Quarterly 14(2): 206–215.

    Article  Google Scholar 

  • Schroeder, D. and Gefenas, E. (2012) Realizing benefit sharing – The case of post-study obligations. Bioethics 26(6): 305–314.

    Article  Google Scholar 

  • Setouhy, M.E. et al (2004) Moral standards for research in developing countries. From “reasonable availability” to “fair benefits”. The Hastings Center Report 34(3): 17–27.

    Article  Google Scholar 

  • Star, S.L. (1989) The structure of ill-structured solutions: Boundary objects and distributed heterogeneous problem solving. In: L. Gasser and M. Huhns (eds.) Distributed Artificial Intelligence 2. San Mateo, CA: Morgan Kauffmann, pp. 37–54.

    Chapter  Google Scholar 

  • Star, S.L. (2010) This is not a boundary object: Reflections on the origin of a concept. Science, Technology, & Human Values 35(5): 601–617.

    Article  Google Scholar 

  • Star, S.L. and Griesemer, J. (1989) Institutional ecology, “translation” and boundary objects: Amateurs and professionals in Berkeley’s museum of vertebrate zoology, 1907–30. Social Studies of Science 19(3): 387–420.

    Article  Google Scholar 

  • Stefanov, I. (2007) Clinical trials come to Russia. International Clinical Trials (Fall): 43–50.

  • Stefanov, I. (2008) Russian revolution. European Pharmaceutical Contractor (Spring): 14–18.

  • Stefanov, I. and Tverdokhleb, P. (2008) Russia grows its CRO market. Applied Clinical Trials, 1 April.

  • Sunder Rajan, K. (2010) The experimental machinery of global clinical trials: Case studies from India. In: A. Ong and N.N. Chen (eds.) Asian Biotech: Ethics and Communities of Fate. Durham: Duke University Press, pp. 55–80.

    Chapter  Google Scholar 

  • Timmermans, S. and McKay, T. (2009) Clinical trials as treatment option: Bioethics and health care disparities in substance dependency. Social Science & Medicine 69(12): 1784–1790.

    Article  Google Scholar 

  • Wadmann, S. (2014) Physician−industry collaboration: Conflicts of interest and the imputation of motive. Social Studies Of Science 44(4): 531–554.

    Article  Google Scholar 

  • Wadmann, S. and Hoeyer, K. (2014) Beyond the “therapeutic misconception”: Research, care and moral friction. BioSocieties 9(1): 3–23.

    Article  Google Scholar 

  • Williams, S., Martin, P. and Gabe, J. (2011) The pharmaceuticalisation of society? A framework for analysis. Sociolology of Health & Illness 33(5): 710–725.

    Article  Google Scholar 

  • Wolters, A., de Wert, G., van Schayck, O. and Horstman, K. (2014) Constructing a trial as a personal lifestyle project: Participants’ experiences in a clinical study for nicotine vaccination. Social Science & Medicine 104: 116–123.

    Article  Google Scholar 

  • Zingerman, B. (2013) Electronic medical record and principles of its organisation. IT in Health Care/Зингерман, Б. (2013) Электронная медицинская карта и принципы ее организации. ИТ в здравоохранении. http://www.osp.ru/medit/blogs/bz/bz_109.html, accessed 1 February 2014.

  • Zvonareva, O., Engel, N., Martsevich, S., de Wert, G. and Horstman, K. (2015) International clinical trials, cardiovascular disease and treatment options in the Russian Federation: Research and treatment in practice. Social Science and Medicine 128: 255–262.

    Article  Google Scholar 

Download references

Acknowledgements

This article benefited from perspectives of many physicians-investigators and clinical research experts in Russia. Authors are especially grateful to Dr Grant Shekhyan and Svetlana Zavidova. The authors appreciate careful proofreading of the text by Jean Kollantai.

Authors declare no conflict of interest.

Author information

Authors and Affiliations

  1. Department of Health, Ethics and Society, Maastricht University, Postbus 616, Maastricht, 6200MD, the Netherlands

    Olga Zvonareva, Nora Engel & Klasien Horstman

  2. Policy Analysis and Studies of Technologies Centre, National Research Tomsk State University, Tomsk, 634050, Russian Federation

    Olga Zvonareva

  3. Department of Preventive Pharmacotherapy, the National Research Center for Preventive Medicine, Moscow, 101990, Russian Federation

    Natalia Kutishenko

Authors
  1. Olga Zvonareva
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Nora Engel
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Natalia Kutishenko
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Klasien Horstman
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Olga Zvonareva.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Zvonareva, O., Engel, N., Kutishenko, N. et al. (Re)configuring research value: international commercial clinical trials in the Russian Federation. BioSocieties 12, 392–414 (2017). https://doi.org/10.1057/biosoc.2016.11

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1057/biosoc.2016.11

Keywords

Search

Navigation