Dismantling and rebuilding bureaucracies: reinventing wheels on rebranded hubs.

Biomedical research, education, and health care are not standardized products. It would be one thing to imagine you can enter an academic health center and undertake research, the way you can walk into a coffee house franchise, order a latte and expect to get the same drink, no matter where you were in the world. For research, this isn’t realistic, and it may never be. It is true that process standardization (e.g., check lists) will get us part of the way in improving health care and research conduct (e.g., efficient regulatory processes). In multi–center studies, one needs to have the research protocol implemented identically at each site to minimize between–site variability; however, this is an on–going challenge every time a large study is mounted. Indeed, in process improvement, it’s not that you can do one big thing to engineer major improvements, you have to do lots of little things right, all the time, across the entire organization. In biomedical research, the local needs, resources, and histories of each university, medical school, and health care center are so varied, adapting to thrive in their local cultures to take advantage of community resources, that the challenges of implementing standardized work flows and process improvements for research, training, and education are immense. On top of this, no one knows where the next great breakthrough in scientific thought or investigation will come from; our systems need to be optimized to take advantage and facilitate serendipity and rapidly implement discovery into improved care. So what types of adaptive structures do we need to aid and abet effective clinical and translational science? This has been the hot topic for the Clinical and Translational Science Award (CTSA) community ever since Dr. Elias Zerhouni’s 2005 vision to transform the General Clinical Research Centers (GCRCs) into centers for Clinical and Translational Science.1 “Infrastructure” is out of favor at the moment as a concept worthy of support; it is indispensible, however; one still needs a bridge to efficiently and safely cross a river. The value of a federalized approach to supporting research infrastructures is that assurances are put in place that the work will be conducted as safely and responsibly as possible, no matter which sites are used. As the GCRCs transformed into the CTSAs, one bureaucracy was dismantled and a new one, more complex with increased mandates, was erected (Figure 1). Figure 1 Co–evolution of the NCATS and the CTSA When CTSA 1.0 reached a critical mass in 2008, a community effort, with broad input, established key strategic goals and the new expectations settled in. The ground shifted, as the National Center for Research Resources devolved in 2011 and the National Center for Advancing Translational Sciences (ACTS) was set up in 2012; the National Institutes of Health and the CTSAs are now experiencing new evolutionary pressures. Once again, a complex organizational structure has been dismantled and, by necessity, a new one is being constructed – this time with a more centralized management approach. Core foci, driven by the 2013 Institute of Medicine Report,2 and honed by a NCATS Advisory Council Working Group,3 are being identified and new structures are being put in place. While this is happening, in efforts to streamline processes and improve outcomes, there are risks in disenfranchising and demoralizing important segments of the existing Translational Science workforce. Indeed, there are already ripple effects that are being heard in the potential formation of NCATS sanctioned ‘special interest groups’ among CTSA consortium members, in addition to the primary NCATS foci - these have the feel of, dare I say it, ‘Key Function Committees.’ The complexity of the translational research enterprise is re–exerting itself. How the symbiotic relationships between the NIH and the CTSA community evolve to more effective organizational structures in the next two years is of intense interest to everyone in the field. The CTSA re–branding from academic homes to ‘hubs’ doesn’t resonate well in some quarters. While hubs are meant as centers of activity (‘innovation hubs’, ‘financial hubs’), they are often points of transition, where people and goods are simply moved from one place to another - nothing of value gets created there. In airline transportation, hubs are larger sites with smaller centers feeding into them. This view has the potential to marginalize many research organizations who would view themselves as relegated to second class status; this also has the effect of leaving out large segments of the US population that are served by academic centers in their own unique geographic settings. Should the national CTSA organization develop into a system of large ‘hubs’ with spokes to smaller centers, it will be incumbent on the hubs to create respectful and meaningful collaborations within their networks. Just as biodiversity is necessary for strong ecosystems, research diversity is needed to maintain a thriving clinical and translational science network. Rather than ‘hubs,’ all academic centers (not just CTSAs) could better be viewed as ‘hives,’ where scientists go out in the environment (local, regional, international), conduct their experiments, return to the hive, share their data, and communicate their findings. Hives convey a sense of communal purpose with each member working for the colony’s success. Specifically, hives allow for and encourage pollination, and in interacting with the environment, hive members are cross-pollinators that increase diversity and vigor. The translational research honey, the new knowledge that leads to improved health care, is the product of this interactive activity. The Association for Clinical and Translational Sciences’ goal is to be a hive of productive academic professional activity that facilitates all clinical and translational science across multiple individuals, organizations, and disciplines.