Research Summary
Research Summary
Clinical Trials as a setting for Health Policy and Management Research
Description
The clinical trial marketplace is in flux. A decade ago, pharmaceutical firms almost exclusively conducted the study of their novel drug compounds within major academic medical centers. But today, industry-sponsored clinical trials are increasingly using community physicians and for-profit, dedicated research centers to manage their clinical development projects involving human subjects.
This research project seeks to explain and exploit the variation among these different types of investigative sites. The first of three papers describes why the market share of industry-sponsored studies has changed so dramatically, exacerbating fears about patient safety and scientific validity. The other two papers investigate whether these diverse investigative sites vary significantly in their operational productivity. Using proprietary benchmark data from a firm that specializes in matching biopharmaceutical sponsors with available clinical research organizations, I seek to measure how well different sites recruit, enroll, and process study subjects within a clinical trial. The project will investigate several hypotheses for superior performance, including individual experience, organizational structure, financial incentives, and scale economies.
In the second paper, I find that site-level enrollment is significantly associated more with the characteristics of the organization and supporting personnel (e.g., the type of site and study coordinator experience) than with the attributes of the investigator. Smaller sites with a large, local patient volume or high advertising budgets consistently outperformed larger organizations with a strong referral network. This project seeks to contribute to the health policy community in two ways. First, by elucidating best practices in the management of clinical trial sites, this research may help to reduce the enormous cost to develop a pharmaceutical compound, potentially reducing the price of new products. Second, this project will emphasize that the management of clinical research is also an important component to the efficient development of new medical therapies. This finding is especially salient to the National Institutes of Healths Roadmap plan, which seeks to address a potential bottleneck in medical technology development through a major campaign to train more physicians in the scientific principles (rather than the administrative practices) underlying clinical research.
The third paper tests the concept of operational focus in this context. From a management perspective, the study of clinical trials provides a unique opportunity for research into organizational theory. Within a given trial, multiple investigative sites recruit identically eligible volunteers, enroll them into a common clinical protocol, and process them according to the same quality specifications. However, different types of sites manage their clinical trial business in very different ways. For example, community physicians conduct clinical trials only as a side opportunity, whereas dedicated research centers generate revenue only from the per-patient budgets from multiple protocols. Thus, this setting allows us to test whether organizational structure and management are associated with increased productivity, as measured by higher patient enrollment within a specific protocol.
Originally applied to the manufacturing sector, the theory of focus argues that production-focused firms should devote their resources to a single type of product, allowing them to become more efficient in their operations. Measuring focus as the segmentation of the clinical trial practice from daily patient care activities, I find that focused firms significantly outperform their unfocused counterparts, even after controlling for the associated, increased volume and experience of dedicated research sites. Further, we find evidence that diversified firms that formally separate the clinical trial and patient care segments through a plant-within-a-plant strategy achieve enrollment figures that are statistically equivalent to those of a dedicated research focused-factory.