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Healthy Volunteering and Phase I Clinical Drug Trials in the UK

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Healthy Volunteers in Commercial Clinical Drug Trials

Abstract

This chapter introduces the rationale, context, and main themes of the book. It explores what clinical drug trials are and why a sociological analysis of human involvement is important. It provides a context of human involvement in clinical drug trials; this includes a discussion on the history of human involvement and interrogation of the volunteer as a concept. This chapter charts the changes to regulatory frameworks and how they brought about the shift from the use of captive populations to ‘volunteers’ capable of rational consent. It also includes a discussion on the commercial contexts in which clinical drug trials take place today.

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References

  • Abadie, R. (2010). The professional guinea pig: Big pharma and the risky world of human subjects. London: Duke University Press.

    Book  Google Scholar 

  • ABPI. (2012). Guidelines for phase 1 clinical drug trials (2012 ed.). http://www.abpi.org.uk/our-work/library/guidelines/Pages/phase-1-trials-2012.aspx.

  • Abraham, J. (1997). The science and politics of medicines regulation. Sociology of Health & Illness, 19(19B), 153–182.

    Article  Google Scholar 

  • Angell, M. (1997). The ethics of clinical research in the third world. New England Journal of Medicine, 337, 847–848.

    Article  Google Scholar 

  • Armstrong, T. D., et al. (1999). Attitudes of African Americans toward participation in medical research. Journal of Applied Social Psychology, 29(3), 552–574.

    Article  Google Scholar 

  • Bartfai, T., & Lees, G. V. (2006). Drug discovery: From bedside to Wall Street. Cambridge: Academic Press.

    Google Scholar 

  • Bolton, T. (2005). “Never volunteer for anything”: The concept of the “volunteer” in human experimentation during the Cold War. University of Sussex Journal of Contemporary History, 9, 4–14.

    Google Scholar 

  • Bourdieu, P. (2005). The social structures of the economy. Cambridge: Polity.

    Google Scholar 

  • Carpenter, D. (2014). Reputation and power: Organizational image and pharmaceutical regulation at the FDA: Organizational image and pharmaceutical regulation at the FDA. Princeton, NJ: Princeton University Press.

    Google Scholar 

  • Corrigan, O. (2003). Empty ethics: The problem with informed consent. Sociology of Health & Illness, 25(7), 768–792.

    Article  Google Scholar 

  • Corrigan, O., & Tutton, R. (2006). What’s in a name? Subjects, volunteers, participants and activists in clinical research. Clinical Ethics, 1(2), 101–104.

    Article  Google Scholar 

  • Department of Work and Pensions. (2014). Mandatory work activity provider guidance-incorporating universal credit UC guidance. UK Government. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/420990/mandatory-work-activity-april-15.pdf.

  • Devine, E. G., et al. (2013). Concealment and fabrication by experienced research subjects. Clinical Drug Trials, 10(6), 935–948.

    Article  Google Scholar 

  • Edelblute, H. B., & Fisher, J. A. (2015). Using “clinical trial diaries” to track patterns of participation for serial healthy volunteers in US phase I studies. Journal of Empirical Research on Human Research Ethics, 10(1), 65–75.

    Google Scholar 

  • Elliott, C. (2008). Guiea-pigging, Healthy human subjects for drug-safety trials are in demand. But is it a living?. New Yorker (New York, NY: 1925), 36–41.

    Google Scholar 

  • Elliott, C. (2014, July 28). The best-selling, billion-dollar pills tested on homeless people: How the destitute and the mentally ill are being used as human lab rats. Medium, July 28. https://medium.com/matter/did-big-pharma-test-your-meds-on-homeless-people-a6d8d3fc7dfe.

  • Elliott, C., & Abadie, R. (2008). Exploiting a research underclass in phase 1 clinical drug trials. New England Journal of Medicine, 358(22), 2316–2317.

    Article  Google Scholar 

  • Epstein, S. (2004). Bodily differences and collective identities: The politics of gender and race in biomedical research in the United States. Body & Society, 10(2–3), 183–203.

    Article  Google Scholar 

  • Epstein, S. (2008). The rise of recruitmentology: Clinical research, racial knowledge, and the politics of inclusion and difference. Social Studies of Science, 38(5), 801–832.

    Article  Google Scholar 

  • Featherstone, K. (2003). The experience of trial participation [Editorial]. The Journal of Rheumatology, 30(4), 646–647.

    Google Scholar 

  • Featherstone, K., & Donovan, J. L. (2002). “Why don’t they just tell me straight, why allocate it?” The struggle to make sense of participating in a randomised controlled trial. Social Science & Medicine, 55(5), 709–719.

    Article  Google Scholar 

  • Featherstone, K., & Donovan, J. L. (2003). Random allocation or allocation at random? Patients’ perspectives of participation in a randomised controlled trial. In M. Bury & J. Gabe (Eds.), The sociology of health and illness: A reader. London: Routledge.

    Google Scholar 

  • Fisher, J. A. (2009). Medical research for hire: The political economy of pharmaceutical clinical drug trials. New Brunswick: Rutgers University Press.

    Google Scholar 

  • Fisher, J. A. (2015). Feeding and bleeding: The institutional banalization of risk to healthy volunteers in phase I pharmaceutical clinical drug trials. Science, Technology and Human Values, 40(2), 199–226.

    Article  Google Scholar 

  • Fisher, J. A., & Kalbaugh, C. A. (2011). Challenging assumptions about minority participation in US clinical research. American Journal of Public Health, 101(12), 2217–2222.

    Google Scholar 

  • Geissler, P. W. (2011). “Transport to where?”: Reflections on the problem of value and time à propos an awkward practice in medical research. Journal of Cultural Economy, 4(1), 45–64.

    Article  Google Scholar 

  • Goldacre, B. (2012). Bad pharma: How drug companies mislead doctors and harm patients. London: Fourth Estate.

    Google Scholar 

  • Goldby, S. (1971). Experiments at the Willowbrook State School. The Lancet, 297(7702), 749.

    Article  Google Scholar 

  • Guideline, ICH Harmonised Tripartite. (2009). Nonclinical evaluation for anticancer pharmaceuticals S9. International Conference on Harmonization.

    Google Scholar 

  • Gupta, P., et al. (2012). Phase I clinical drug trials of anticancer drugs in healthy volunteers: Need for critical consideration. Indian Journal of Pharmacology, 44(4), 540.

    Article  Google Scholar 

  • Hallowell, N., et al. (2010). An investigation of patients’ motivations for their participation in genetics-related research. Journal of Medical Ethics, 36(1), 37–45.

    Article  Google Scholar 

  • Harris, Y., et al. (1996). Why African Americans may not be participating in clinical drug trials. Journal of the National Medical Association, 88(10), 630.

    Google Scholar 

  • Hazelgrove, J. (2002). The old faith and the new science: The Nuremberg code and human experimentation ethics in Britain, 1946–1973. Social History of Medicine, 15(1), 109–135.

    Article  Google Scholar 

  • Hedgecoe, A. (2013, October). A deviation from standard design? Clinical drug trials, research ethics committees and the regulatory co-construction of organizational deviance. Social Studies of Science,44(1), 59–81.

    Google Scholar 

  • Illich, I. (1995). Limits to medicine: Medical nemesis—The expropriation of health. New York: Marion Boyars Publishers, Incorporated.

    Google Scholar 

  • Kerr, D., et al. (Eds.). (2006). Clinical drug trials explained: A guide to clinical drug trials in the NHS for healthcare professionals. Oxford: Blackwell.

    Google Scholar 

  • Kohli-Laven, N., et al. (2011). Cancer clinical drug trials in the era of genomic signatures: Biomedical innovation, clinical utility, and regulatory-scientific hybrids. Social Studies of Science, 41(4), 487–513.

    Google Scholar 

  • Lemmens, T., & Elliott, C. (1999). Guinea pigs on the payroll: the ethics of paying research subjects. Accountability in research, 7(1), 3–20.

    Google Scholar 

  • Lemmens, T., & Elliott, C. (2001). Justice for the professional guinea pig. American journal of bioethics, 1(2), 51–53.

    Google Scholar 

  • Lurie, P., & Wolfe, S. M. (1997). Unethical trials of interventions to reduce perinatal transmission of the Human Immunodeficiency Virus in developing countries. New England Journal of Medicine, 337(12), 853–856.

    Google Scholar 

  • Lurie, P., & Wolfe, S. M. (2012). Unethical trials of interventions to reduce perinatal transmission of the Human Immunodeficiency Virus in developing countries. Arguing About Bioethics, 479.

    Google Scholar 

  • Marks, H. (2009). What does evidence do? Histories of therapeutic research. In C. Bonah (Ed.), Harmonizing drugs. Standards in 20th-century pharmaceutical history. Paris: Glyphe.

    Google Scholar 

  • MHRA. (2014). UK clinical trial authorisation assessment performance. http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Clinicaltrials/UKclinicaltrialauthorisationassessmentperformance/index.htm.

  • Mirowski, P., & Van Horn, R. (2005). The contract research organization and the commercialization of scientific research. Social Studies of Science, 35(4), 503–548.

    Article  Google Scholar 

  • Monahan, T., & Fisher, J. A. (2015). “I’m Still a Hustler”: Creative and entrepreneurial responses to precarity by participants in phase I clinical drug trials. Economy and Society, 44, 545–566.

    Article  Google Scholar 

  • Mwale, S. (2016). Same difference? From Northwick park in 2006 to Rennes in 2016. Cost of Living Blog. http://www.cost-ofliving.net/same-difference-from-northwick-park-in-2006-to-rennes-in-2016/.

  • Nelson, E. (2005). Liberty: One concept too many? Political Theory, 33, 58–78.

    Google Scholar 

  • ONS (2014). What does the UK pharmaceutical industry look like today? Part of Index of Production. Release available at http://www.ons.gov.uk/ons/rel/iop/index-of-production/april-2014/sty-pharmaceuticals.html. Accessed 15 January 2015.

  • Pappworth, M. H. (1967). Experiments on man. British Medical Journal, 3(5565), 616.

    Article  Google Scholar 

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

    Article  Google Scholar 

  • Petryna, A. (2009). When experiments travel: Clinical drug trials and the global search for human subjects. Princeton: Princeton University Press.

    Google Scholar 

  • Petryna, A., & Kleinman, A. (2006). The pharmaceutical nexus. In A. Petryna, A. Lakoff, & A. Kleinman (Eds.), Global pharmaceuticals: Ethics, markets, practices. Durham: Duke University Press.

    Chapter  Google Scholar 

  • Pocock, J. (2000). Clinical drug trials: A practical approach. Chichester: Wiley.

    Google Scholar 

  • Rägo, L., & Santoso, B. (2008). Drug regulation: History, present and future. Drug benefits and risks: International textbook of clinical pharmacology (Rev. 2nd ed.). Available at: http://www.who.int/entity/medicines/technical_briefing/tbs/Drug_Regulation_Histoy_Present_Future.pdf.

  • Rajan, K. S. (2005). Subjects of speculation: Emergent life sciences and market logics in the United States and India. American Anthropologist, 107(1), 19–30.

    Article  Google Scholar 

  • Rajan, K. S. (2006). Biocapital: The constitution of postgenomic life. Durham: Duke University Press.

    Google Scholar 

  • Rosner, D. (1996). Human guinea pigs: Medical experimentation before World War II. JSTOR. http://www.jstor.org/stable/30030721.

  • Savulescu, J., & Spriggs, M. (2002). The hexamethonium asthma study and the death of a normal volunteer in research. Journal of Medical Ethics, 28(1), 3–4.

    Article  Google Scholar 

  • Schutz, A. (1970). Reflections on the problem of relevance (R. M. Zaner, Trans.). New Haven: Yale University Press.

    Google Scholar 

  • Scocozza, L. (1989). Ethics and medical science. On voluntary participation in biomedical experimentation. Acta Sociologica, 32(3), 283–293 (Taylor & Francis Ltd).

    Google Scholar 

  • Shah, S. (2006). The body hunters: Testing new drugs on the world’s poorest patients. New York: New Press.

    Google Scholar 

  • Sondhi, G. (2013). Gendering international student mobility: An Indian case study. Available at: http://sro.sussex.ac.uk/46066/1/Sondhi,_Gunjan.pdf.

  • Stebbings, R., Poole, S., & Thorpe, R. (2009). Safety of biologics, lessons learnt from TGN1412. Current Opinion in Biotechnology, 20(6), 673–677.

    Article  Google Scholar 

  • Tolich, M. (2010). What if Institutional Research Boards (IRBs) treated healthy volunteers in clinical trials as their clients? Australasian Medical Journal, 3(12), 767–771. doi 10.4066/AMJ.2010.431

  • Tishler, C. L., & Bartholomae, S. (2002). The recruitment of normal healthy volunteers: A review of the literature on the use of financial incentives. The Journal of Clinical Pharmacology, 42(4), 365–375.

    Article  Google Scholar 

  • Tishler, C. L., & Bartholomae, S. (2003). Repeat participation among normal healthy research volunteers: Professional guinea pigs in clinical trials? Perspectives in Biology and Medicine, 46(4), 508–520.

    Google Scholar 

  • Towse, A. (1996). The UK pharmaceutical market. PharmacoEconomics, 10(2), 14–25.

    Article  Google Scholar 

  • Washington, H. A. (2006). Medical Apartheid: The dark history of medical experimentation on Black Americans from colonial times to the present. New York: Doubleday.

    Google Scholar 

  • Weber, M., Swindler, A., & Parsons, T. (1963). The sociology of religion. Boston, MA: Beacon Press.

    Google Scholar 

  • Will, C. M. (2011). Mutual benefit, added value? Journal of Cultural Economy, 4(1), 11–26.

    Google Scholar 

  • Wilson, J. (2000). Volunteering. Annual Review of Sociology, 26(1), 215–240.

    Article  Google Scholar 

  • Wilson, J., & Musick, M. (1999). The effects of volunteering on the volunteer. Law and contemporary problems, 62(4), 141–168.

    Google Scholar 

  • Wuthnow, R. (1993). Altruism and sociological theory. The Social Service Review, 67(3), 344–357.

    Google Scholar 

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  1. School of Applied Social Sciences, University of Brighton, Brighton, UK

    Shadreck Mwale

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  1. Shadreck Mwale
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Mwale, S. (2017). Healthy Volunteering and Phase I Clinical Drug Trials in the UK. In: Healthy Volunteers in Commercial Clinical Drug Trials. Palgrave Macmillan, Cham. https://doi.org/10.1007/978-3-319-59214-5_1

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  • DOI: https://doi.org/10.1007/978-3-319-59214-5_1

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  • Publisher Name: Palgrave Macmillan, Cham

  • Print ISBN: 978-3-319-59213-8

  • Online ISBN: 978-3-319-59214-5

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