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Thesis ID: CBB001561585

Pharmaceutical Paternalism and the Privatization of Clinical Trials (2005)

Rensselaer Polytechnic Institute
Hess, David J.
Publication date: 2005
Language: English

Publication Date: 2005
Edition Details: Advisor: Hess, David J.
Physical Details: 333 pp.

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This dissertation examines the privatization of clinical trials--the process of pharmaceutical companies' outsourcing their drug research to private practice physicians around the country. With privatization have come new relationships among researchers, clinicians, and patients as well as new ethical concerns and dilemmas. In private-sector research, the doctor-patient relationship now coexists with a researcher-subject relationship, which creates role and ethical conflicts within the clinic. More broadly, the proliferation of new professions, organizations, and roles has created different configurations of power and gender within the clinic, as well as within the clinical trials industry itself. This dissertation analyzes these new relationships under the rubric of "pharmaceutical paternalism": the increasing hegemony of profit- oriented research culture in the clinical setting. The research that informs this analysis of the culture of clinical trials is based on 12-months of fieldwork in the Southwestern U.S. This qualitative research consisted of 57 interviews and observation at more than twenty for- profit research organizations in two major cities. Semi-structured interviews were clustered to get the perspective of multiple employees at individual investigative sites, including physicians, research staff, administrators, and human subjects. Investigative sites were chosen to create a diverse sample of organizational forms: private practices, dedicated research sites, SMOs, CROs, and large (non-academic) hospitals. Additionally, the research included attendance at industry conferences, membership and subscriptions in industry professional organizations, and participant-observation in a Phase I clinical trial. The methods for this research also inform the structure of the dissertation itself. I adopt an ethnographic mode of writing that relies on what my informants had to say about organizational cultures within which they operate everyday. I use extensive quotes to highlight how my informants themselves speak about and understand the world of private-sector pharmaceutical research and the types of role and ethical conflicts they experience as part of that world. In the concluding section of each chapter, however, I adopt an analytic tone to explain how the described findings illustrate the culture of pharmaceutical paternalism that this dissertation seeks to document as a product of the privatization of clinical trials.

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Description Cited in Diss. Abstr. Int. A 66/07 (2006): 2727. UMI pub. no. 3183626.

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