Tag: Jill A. Fisher

This paper questions the implications of entrepreneurial responses to conditions of employment precarity by ‘healthy volunteers’ in phase I clinical trials in the United States. Such individuals are typically serial participants who often identify as professional volunteers and seek out drug studies as their primary source of income. Drawing on...

Phase I testing of investigational drugs relies on healthy volunteers as research participants. Many U.S. healthy volunteers enroll repeatedly in clinical trials for the financial compensation. Serial participants are incentivized to ignore restrictions on their participation, and no centralized clinical trial registry prevents dual enrollment. Little is currently known about...

The first stage of testing new pharmaceuticals in humans is referred to as a phase I clinical trial. The purpose of these studies is to test the safety of the drugs and to establish appropriate doses that can later be given to patients. Most of these studies are conducted under...

The process of informed consent is fundamental to basic scientific research with human subjects. As one aspect of the scientific enterprise, clinical drug trials rely on informed consent documents to safeguard the ethical treatment of trial participants. This paper explores the role of heteronormative assumptions within this process, postulating the...

In spite of a growing literature on pharmaceuticalization, little is known about the pharmaceutical industry’s investments in research and development (R&D). Information about the drugs being developed can provide important context for existing case studies detailing the expanding–and often problematic–role of pharmaceuticals in society. To access the pharmaceutical industry’s pipeline,...

Phase I clinical trials are the first stage of testing new pharmaceuticals in humans. The majority of these studies are conducted under controlled, inpatient conditions using healthy volunteers who are paid for their participation. This article draws on an ethnographic study of six phase I clinics in the United States,...

Aggregate data about pharmaceutical research and development (R&D) tend to examine Phase III trials. Hence, there are few published data about investigational drugs in earlier phases of clinical development that might fail. It is also unclear how well R&D corresponds to disease burden. We track the pharmaceutical pipeline using data...

This paper introduces the term “structural coercion” to underscore the ways in which broader social, economic, and political contexts act upon individuals to compel them to enroll as subjects in clinical research. The paper challenges the adequacy of the concepts of “coercion” and “undue influence” in determining when research participation...

Establishing contacts and gaining permission to conduct ethnographic or qualitative research can be time-consuming and stressful processes. Gaining access can be especially challenging when representatives of prospective research sites see their work as being sensitive and would prefer to avoid outside scrutiny altogether. One result of this dynamic is that...