From Free to Free Market: Cost Recovery in Federally Funded Clinical Research

Abstract

In a climate of increased expectation for the translation of research, academic clinical research units are looking at new ways to streamline their operation and maintain effective translational support services. Clinical research, although undeniably expensive, is an essential step in the translation of any medical breakthrough, and as a result, many academic clinical research units are actively looking to expand their clinical services despite financial pressures. We examine some of the hybrid academic-business models in 19 clinical research centers within the Clinical and Translational Science Award consortium that are emerging to address the issue of cost recovery of clinical research that is supported by the United States federal government. We identify initiatives that have succeeded or failed, essential supporting and regulatory components, and lessons learned from experience to design an optimal cost recovery model and a timeline for its implementation.

Conducting clinical trials—costs, impacts, and the value of clinical trials networks: A scoping review

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From an Infrastructure to a Service‐based Business Model: 5 Years of Mobile Clinical Research at the University of Michigan

“…With the ubiquitous funding squeeze across academic research institutions, hybrid academic‐business models are evolving to meet the challenge of providing more and improved clinical research services with little or no increase in federal resources. Moreover, the growing population‐based clinical research portfolio requires a larger and increasingly diverse participant population for successful completion, which means engaging more people from vulnerable groups for whom participation in clinical research represents additional barriers .…”

The What and Why of Translational Medicine

“…The translational medicine centers require sustained funding for the resources that investigators need to design and conduct high-quality clinical research. One way in which to achieve this is to have well-constructed cost-recovery processes [10]. Resources at most AHCs in the USA were not integrated prior to the CTSA initiative.…”