In a commentary in the July issue of Science, CTSI's Lynda Jacobsen, MPA, Deputy Director of the Clinical Research Services program, joins experts from five other Clinical and Translational Science Award (CTSA) institutions to examine hybrid academic-business that are emerging to address cost recovery in federally funded clinical research.
From the commentary, From Free to Free Market: Cost Recovery in Federally Funded Clinical Research:
"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."
The conclusions:
"This work provides a snapshot of the cost recovery landscape in clinical research cores across the United States, illustrating both the nascent and the dynamic nature of the field within an evolving CTSA environment. Although the sample set is limited only to approximately one-third of the consortium, several common features and trends have been identified. The CSCs are testing new ground with the introduction of cost recovery, and although remarkable progress has been made by the pioneering organizations, important concerns remain about the long-term implications. Many CTSAs are reluctant to introduce charges that they believe may not be in line with their academic mission, and questions remain about the effect of a CRM on the quality and accessibility of research services. Nevertheless, several positive impacts of CRMs were identified from this work. In particular, some CSCs reported that new studies are generally more structured because PIs may be avoiding unnecessary costs, and in order to retain their customer base, CSCs may be increasingly motivated to provide quality, cost-effective services. An unexpected impact of the CRM is the observation of a new PI altruism, in which senior PIs have declined financial support on the basis that their more junior colleagues need it more. The cautious consensus is that these efforts appear to be strengthening the underlying science and, in turn, increasing CSC access relative to the pre-CRM environment.
Although clinical research is costly, it is an essential step in the translational process. Developing robust business models to underpin clinical research is a vital step in the evolution of the CTSA, and an undeniable part of that evolution is now cost recovery. In the face of challenged industry pipelines, radical new business models are being established to drive translation in drug development, and with the synergies of collaboration, the CTSA consortium is well placed to contribute to this new translational climate."