Dissertation Title： "Essays on the Management of Clinical Trial Sites: Lessons for Health Policy, Technology Development, and Organizational Theory"Changes in the costs and complexities of developing new pharmaceuticals have led to transformations in the clinical research industry. The influx of new types of research sites and principal investigators has created substantial differences in how clinical research studies are conducted and managed. This research thesis utilizes the homogeneity of clinical research tasks across sites, while exploiting the structural variation among these different types of investigative centers. Within a given trial, multiple investigators recruit identically eligible volunteers, enroll them into a common clinical protocol, and process them according to the same quality specifications. Yet, these sites differ in important organizational and demographic characteristics. Using proprietary benchmark data from biopharmaceutical sponsors and a clinical research services firm, I utilize multivariate regression analysis with protocol-level fixed effects to determine the characteristics that predict site-level clinical trial enrollment. My research is divided into three separate papers that seek to provide lessons for clinical research, health policy, and organizational theory.
Paper one documents that conducting clinical research requires administrative focus and coordination, suggesting that managerial and organizational characteristics of investigative sites have a large impact on the final enrollment tallies. Thus, policies aimed at improving the productivity of the clinical development process, such as the National Institutes of Health’s Roadmap for Medical Research, should also focus on the managerial issues surrounding clinical research. Paper two uses geographic variation across trial sites to show that the uninsured are disproportionately enrolling in industry-sponsored clinical trials, confirming the existence of a hole in the nation’s safety-net provider system.
Lastly, paper three seeks to inform the management of diversified firms by exploring the effect of operational focus on productivity. It finds that sites that focus on conducting clinical trials significantly outperform those that mix trial activity with the provision of traditional patient care. However, diversified sites that separate clinical trial activity and traditional patient care through a “plant-within-a-plant” structure achieve performance that is statistically equivalent to that of a fully focused site dedicated solely to clinical trials.