In This Article Expand or collapse the "in this article" section Clinical Trials

  • Introduction
  • Textbooks
  • History of RCTs
  • RCT Design and Its Adaptations
  • Knowing and Not Knowing
  • Controversies and Failures
  • Governance
  • Ebola
  • HIV

Anthropology Clinical Trials
by
Salla Sariola
  • LAST MODIFIED: 25 March 2020
  • DOI: 10.1093/obo/9780199766567-0242

Introduction

Clinical trials are tests of safety and efficacy for drugs, vaccines, and diagnostics. Methods by with which trials are conducted include randomized controlled trials (RCTs) and equivalence studies. Randomized controlled trials compare an experimental compound with a placebo, or a previously existing drug, seeking to establish safety and/or efficacy. RCTs can also be conducted on social interventions or policies. According to current standards, trials are conducted in phases, cumulatively including more participants. So called phase I trials are “first-in-man” studies, prior to which animal studies have been conducted. Phases II and III include a higher number of study participants, often in thousands across the world. After phase III, marketing permission is sought—phases IV and V are used to promote the products and gather further evidence of side effects. Trials are also conducted to compare the equivalence of existing and remanufactured products, extend patents of the patent holder, and gain a hold of a new market, resulting in what is at times called “me-too”-drugs. Trials are conducted by public/global health researchers, pharmaceutical companies, and public-private partnerships all of which entail a complex web of actors. Anthropological literature exploring clinical trials has increased since the 2000s and the field reflects a global increase of overseas research by various biomedical actors. Clinical trials are not a new phenomenon, but their recent trajectory and shifting geographical locations has rendered them an object of inquiry. The increase is a consequence of multiple processes including global regulatory changes, emergence of new bilateral actors, and the overall development in countries like India and China that have increased their capacity for knowledge production. Within anthropology, the interest has coincided with and compounded research on globalization and global assemblages that has focused on webs and networks of technologies, ethics, and financial actors. Knowledge production processes have also illuminated the “ontological turn” in anthropology that has explored practices that give rise to objects, materiality, and biology. Following practices that construct pharmaceuticals illuminates the ways in which life itself, bodies, and biologies are socially constructed. Such approach, while not always explicitly, takes inspiration from Bruno Latour’s Actor-Network Theory and science and technology studies. Knowledge production processes are not devoid of power, and a major concern in the literature is the potential for exploitation of research participants, researchers, and local research cultures. In sites where global health research is conducted, health systems are often poor, and strongly divided between public and private health-care providers. Anthropology in/of clinical trials has engendered social scientists’ roles in working also in collaboration with medical researchers and thinking about the social relationships and ethics of international research, justice and universality of values, how to promote the interests and concerns of communities, and how indeed research bioethical regulation itself is a product of neoliberalization of health research.

Textbooks

Key books on clinical trials provide an in-depth view to the breadth of the social study of clinical trials. Included here are volumes that include both edited collections and monographs. They highlight the globalized sites in which clinical trials are conducted, how, and by whom. Randomized controlled trials (RCTs), as analyzed by Timmermans and Berg 2003, is considered as the gold standard of medical research and evidence-based medicine. Production of knowledge, however, is not devoid of social influences: seminal work by Epstein 1998 shows how US AIDS activists shaped the US Food and Drug Administration (USFDA) regulation by which antiretroviral therapy trials were conducted and who was included in them. Rosengarten 2009 continued the focus on HIV interventions and research, and specifically how research produces viruses, materiality, and bodies. Coinciding with this publication was Fisher 2009, which based on long-term fieldwork in the United States outlined how contract research organizations (CROs) recruit participants and conduct research. Petryna 2009 was among the first monograph-length ethnographies of overseas clinical research. Petryna describes how global commercial and publicly funded trials travel and how they shape people’s lives and experiences. The work that goes into implementing research is also the topic of the edited collection Moreira and Will 2010. The authors show that RCTs are a social achievement and that a considerable amount of work goes into producing standardized data. Cooper and Waldby 2014 continues to focus on labor, but not of the researchers themselves. Instead, creating analytical parallels with reproductive labor and Marxist theory, they define the participation in trials as clinical labor. Geissler and Molyneux 2011 presents a collection of articles from Africa that highlight the financial, social, and epistemic differences across which research is conducted. As demonstrated by Sunder Rajan 2017, these differences are part and parcel of international pharmaceutical industry’s operations that make profit out of health and clinical trials, in the context of stark health inequalities internationally. Crane 2013 elaborates on global HIV research that has resulted in the rise of US global health research in Africa, and describes how this “scramble” for Africa has changed research landscapes in the region. Describing the globalizing and neoliberal changes in health research infrastructures, funding strategies, and development priorities since the 2000s, Biehl and Petryna 2013 is an edited collection about health interventions, markets, and evidence used and produced in global health research. Global health research is still often defined by experts; instead, the volume aims to foreground people and their everyday lives.

  • Biehl, João G., and Adriana Petryna, eds. 2013. When people come first: Critical studies in global health. Princeton, NJ: Princeton Univ. Press.

    E-mail Citation »

    This edited collection analyzes the rising global health sector and its interventions, markets, and evidence production. Drawing from an interdisciplinary set of topics, the book shows how the humanitarian, development, and medical programs follow their particular logics that often foreground the interests of experts. The book sets a new agenda for social and humanities research in global health, where people, their aspirations, needs, and struggles come first. Ethnography, the chapters show, plays a key methodological tool in this new agenda.

  • Cooper, Melinda, and Catherine Waldby. 2014. Clinical labor: Human research subjects and tissue donors in the global bioeconomy. Durham, NC: Duke Univ. Press.

    DOI: 10.1215/9780822377009E-mail Citation »

    This book looks at the historical conditions, political economy, and contemporary practices of clinical labor, namely, surrogacy and clinical trial participation. The analysis brings light to classical, Marxist, and post-Fordist theories of labor.

  • Crane, Johanna T. 2013. Scrambling for Africa: AIDS, expertise, and the rise of American global health science. Ithaca, NY: Cornell Univ. Press.

    E-mail Citation »

    In this ethnographic account, Crane shows how sub-Saharan countries previously excluded from the benefits of antiretroviral drug development have turned into central locations of medical knowledge production. Tracing transnational flows of research funding, politics, knowledge, and viruses in HIV/AIDS research in Uganda and the United States, Crane observes the ways global economic inequalities translate into biological ones and may simultaneously, controversially, work as a source of benefit and an object of the aimed intervention for the global research partnerships.

  • Epstein, Steven. 1998. Impure Science: AIDS, activism, and the politics of knowledge. Berkeley and Los Angeles: Univ. of California Press.

    E-mail Citation »

    This seminal text describes how lay AIDS activists pushed for extended participation in early clinical trials on antiretroviral therapies. In so doing, activists brought to question the presumed purity of scientific knowledge production and how social movements can shape regulation.

  • Fisher, Jill A. 2009. Medical research for hire: The political economy of pharmaceutical clinical trials. New Brunswick, NJ, and London: Rutgers Univ. Press.

    E-mail Citation »

    Fisher analyzes how the privatization of pharmaceutical drug trials in the United States has changed the way medical research is performed, arguing that this has been the consequence of simultaneously decreasing revenue for academic physicians and increased obstacles to health care for patients. Contract research organizations that have otherwise not been analyzed in the literature at great length are also included.

  • Geissler, Wenzel, and Sassy Molyneux, eds. 2011. Evidence, ethos and experiment: The anthropology and history of medical research in Africa. New York: Berghahn Books.

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    The edited volume focuses on overseas medical research in Africa. The chapters focus on interactions in clinical studies, drug development and randomized controlled trials, entomological surveys and vector control, ethnobotany, phytopharmacology, and medical anthropology. International collaboration is conducted across vast cultural, economic, and epistemic differences that gives rise to practical and ethical challenges.

  • Moreira, Tiego, and Catherine Will, eds. 2010. Medical proofs, social experiments: Clinical trials in shifting contexts. Aldershot, UK: Ashgate.

    E-mail Citation »

    This edited volume illuminates the often hidden work done by doctors, participants, and wider publics that goes into producing credible data in clinical trials. While RCTs are considered the gold standard of evidence and knowledge production, it also shows how the results are socially produced and outlines helpful critiques of clinical trials.

  • Petryna, Andriana. 2009. When experiments travel: Clinical trials and the global search for human subjects. Princeton, NJ, and Oxford: Princeton Univ. Press.

    DOI: 10.1515/9781400830824E-mail Citation »

    This book analyzes the globalization of commercial medical science following the increased use of pharmaceuticals in the United States, and the recruitment of research subjects in low-income countries that the industry depends on. The book shows the complex processes of the integration of medical trials into local health systems and the benefits and risks involved.

  • Rosengarten, Marsha. 2009. HIV interventions: Biomedicine and the traffic between information and flesh. Seattle: Univ. of Washington Press.

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    Using a diverse set of research materials, Rosengarten demonstrates the ways HIV, medical technologies, and understandings about the body are intertwined and co-construsted, asserting that material as well as informational environments are simultaneously constituted by and constitute HIV.

  • Sunder Rajan, Kaushik. 2017. Pharmocracy: Value, politics, and knowledge in global biomedicine. Durham, NC: Duke Univ. Press.

    DOI: 10.1215/9780822373285E-mail Citation »

    Pharmocracy describes how the pharmaceutical industry maintains and uses hegemonic power to turn health into profit. Using case studies from India, the analysis suggests that the profit is often at the expense of poor and vulnerable populations.

  • Timmermans, Stefan, and Marc Berg. 2003. The gold standard: The challenge of evidence-based medicine and standardization in health care. Philadelphia: Temple Univ. Press.

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    A classic for the study of standards and standardization, The Gold Standard describes the advent of evidence-based medicine (EBM) and the role of shared guidelines, standards, and standardization for medicine and health. The book looks at the historical developments of EBM and shows how and why EBM has become central to health care and research today.

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