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.
State of use of Electronic Data Capture (EDC) tools in randomized controlled trials in India: results from a survey
