Translational Research Evaluation
Maran Subramain, Ph.D.
Evaluator
University of Iowa, United States
Alejandro Comellas, MD
Director of the ICTS Clinical Research Unit
University of Iowa, United States
Patrick Barlow, Ph.D.
Evaluator
University of Iowa, United States
Location: White River Ballroom E
Abstract Information: The Clinical Research Units (CRU) are one of the main spaces where both translational research and science takes place. The Research Unit Network (RUN) is a national association of CRUs from both Clinical & Translational Science Award (CTSA) and non-CTSA institutions created to enable direct communication and collaboration among CRUs. A goal of RUN is to test and disseminate practice standards that have been developed or piloted by individual CRUs to promote widespread adoption of these innovations. Currently, these include: a) the analysis of research service charges and cost-recovery models; b) standardizing assessment of research protocol deviations in CRUs for continuous quality improvement; and c) recruitment and retention of the CRU workforce. These projects focus on developing the science of translational research by improving the operations of conducting it within the CRU. Augmenting these efforts through the greater engagement with the CTSA Evaluators Group will enhance the evaluation capacity and quality, and, by extension, our ability to demonstrate RUN’s overall impact. This session will engage participants in discussion of evaluating ongoing and future RUN initiatives as well as both challenges and opportunities to consider as the network strives to advance the clinical translational science enterprise.
Relevance Statement: In 2014, The National Center for Advancing Translational Science (NCATS) announced that direct support of the Clinical Research Units (CRU) would no longer be allowed for any Clinical Translational Science Awards (CTSA) recipients, leading to the need for hospitals and other research institutes to operate these entities on a service center model [1]. This decision resulted in overlooking these units from discussions related to translational science. To re-establish dialogue between CRUs that would help units benchmark and improve operations, the Research Unit Network (RUN) was created with the express purpose of enabling direct communication, sharing, and collaboration among CRUs. RUN held its first meeting on July 25th, 2018 led by the University of Iowa. At the time, eight institutions joined the network. Within four years the network has grown to 50 institutions, with 79 members. Forty-two CRUs are associated with institutions that are funded by the NCATS CTSA program, and six of the CRUs are located in institutions supported by NIH, NIGMS through the Institutional Development Award Networks for Clinical and Translational Research (IDeA-CTR).
The network provides an opportunity to discuss topics relevant to the operations of clinical and translational research, with the goal of improving translational science. RUN actively engages members through in depth scheduled monthly meeting discussions with various relevant topics regarding the development and evaluation of clinical trials metrics, benchmarks, and scholarly publication and presentation activities. In addition to facilitating discussions around the topics mentioned already, RUN was pivotal in exchanging information and practices during the beginning of the COVID-19 pandemic [2]. This experience resulted in the identification of the unique roles played by CRUs as part of a disaster response.
NCATS has placed a strong focus on translational science with the goal of improving common causes of inefficiencies and failures in translational research projects. This session will introduce the RUN Network, and how the network is contributing to the evaluation of the clinical research unit’s research operations around the country to begin to understand best practices and to develop a learning platform for enhancing efficiencies in CRUs [3]. RUN now provides a unique opportunity to advance the mission of NCATS in studying the general principles of translational science from an empirical approach.
As stated in the abstract above, "augmenting these efforts through the greater engagement with the CTSA Evaluators Group will enhance the evaluation capacity and quality, and, by extension, our ability to demonstrate RUN’s overall impact." Thus, this session will engage participants in discussion of evaluating ongoing and future RUN initiatives as well as both challenges and opportunities to consider as the network strives to advance the clinical translational science enterprise.
1: Nathan, D.G. and D.M. Nathan, Eulogy for the clinical research center. J Clin Invest, 2016. 126(7): p. 2388-91.
2: Subramain, M., et al., Impact of COVID-19 on Clinical Research Units (CRUs). J Clin Transl Sci, 2021. 5(1): p. e167.
3. Comellas, A.P., et al.,Research Unit Network (RUN) as a Learning Research System. J Clin Transl Sci, 2023. (Accepted Manuscript)