Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials

Chapter 4: Coordinating Clinical Trials

66 Ruth,1 a charismatic white woman in her early fifties, welcomed me into her office in the clinical research facilities of a large, successful obstetrics and gynecology private practice. Having worked at the investigative site for more than eight years and at another site for several years prior to that, Ruth had much to tell me about the clinical trials industry. Ruth juggled several roles at the site: research coordinator, recruiter, and “regulatory specialist.” At the time of my second interview with her, she had recently been promoted and was transitioning to the position of site director. Ruth explained to me that clinical research necessitates the involvement of people like her and the other coordinators at the site: studies have the potential to be cold and impersonal, but she and her colleagues provide a warm, compassionate context for that research. Ruth understands that the primary responsibility of coordinators is to ensure that pharmaceutical companies obtain the data they are seeking from subjects in clinical trials. This means finding and enrolling subjects for the studies through recruitment of private-practice patients or community members and then encouraging those subjects to be compliant and continue with the protocols. The pharmaceutical companies assign quotas to the sites for how many subjects they need to recruit and in what time frame they need to be enrolled. This is no small challenge when, in Ruth’s experience, only about 10 percent of the interested potential subjects actually pass the protocol requirements for eligibility and decide to enroll. With those odds, coordinators need to make the active recruiting and screening of subjects a major thrust of their jobs. Chapter 4 Coordinating Clinical Trials Coordinating Clinical Trials 67 At the same time, Ruth explains, another important responsibility of coordinators is to ensure that individual patient-subjects are treated ethically and commit themselves to the research process. She insists that she is not looking for “subjects” to be in the studies but “research partners.” For her site, there is an “ideal” patient-subject, and the difference between who is or is not ideal is based on active, rather than passive, participation in the studies. For example, she receives a fair number of responses to mass media advertisements . Oftentimes people who are motivated by ads to contact her site are primarily interested in how much financial compensation they could receive for their participation in studies. She told me that most of these people are not ideal subjects because it takes more than money to encourage people to be compliant with the study protocols (duties often include writing symptom diaries and coming in frequently for appointments). She says that the best participants are those who embrace the education that she and the other coordinators provide to subjects about their medical conditions and about the details of the studies in which they are enrolling. The dual nature of the job that Ruth pointed out—the need to meet the pharmaceutical companies’ quotas and the selection of active, engaged subjects—is a theme that was woven throughout the narratives of most of the coordinators I interviewed. Fortunately for Ruth, she does not perceive these two tasks as competing with each other. Nonetheless, through my conversations with her and other coordinators, it became apparent that there is an underlying tension between these approaches to the recruitment and retention of human subjects that is rooted in the conflict between research and care. What is more, this tension can be seen as constitutive of coordinators’ professional identities. Dual Roles of Research Coordinators The job description for research coordinators varies widely by investigative site depending on the amount of specialized division of labor in which the site has invested. The basic tasks that need to be done in order for sites to participate in clinical trials include recruiting patient-subjects, screening and enrolling patient-subjects into particular studies, managing the regulatory documents like IRB submissions and FDA forms, and overseeing the financial end of contract negotiation and fee collection. In general, the smaller the investigative site, the more likely it is that these activities all fall within the purview of individual coordinators; at larger sites, these activities are divided up among various employees. Despite this variation, coordinators are always responsible for direct contact with patient-subjects. 68 Medical Research for Hire At its core, the coordinator position is premised on the role of nurses in health care delivery. Like nurses, the...