Patient recruitment companies are small, private businesses that specialize in recruiting patients for clinical trials on behalf of pharmaceutical and medical device industries. The emergence of these companies around the 1990's is part of a broader tendency within the pharmaceutical industry to focus on outsourcing clinical trial research. The organizational complexity of clinical trials has led to the emergence of a new sector devoted to the management and administration of clinical trials. The shift of clinical research to the private sector has raised new questions and ethical concerns about relationships that emerge between the industry, regulating bodies, researchers and human participants (Abadie, 2010; Fisher, 2009; Rajan, 2006; Petryna, 2009). This thesis investigates and describes one aspect of the private clinical trial industry--patient recruitment for clinical research studies and ethical issues that emerge from these activities. The results are based on a year-long ethnographic study including participant observations, document analysis and interviews with stakeholders of recruitment industry. The central argument I develop is that rationales for recruitment tactics are intimately entwined with the market value that these companies see in patient recruitment, and with the market risk that attends this process. This worldview impacts every aspect of the patient recruitment business--starting from the structure of patient recruitment, to the development of marketing campaigns, communication with the public, and all the way through to the relations with clinicians. I argue that the current organization of private industry patient recruitment introduces different ethical questions that are not addressed by the current guidelines.
University of Minnesota Ph.D. dissertation. June 2013. Major: Social and Administrative Pharmacy. Advisor: Linda M. Strand, PhD. 1 computer file (PDF); ix, 252 pages, appendices A-C.
"We get patients": Understanding the culture of patient recruitment organizations.
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