Imagine: a coordinated federated approach that supports translational science and improves health.

Abstract

To be fully successful, Translational Science requires coordinated teamwork from multiple professionals and organizations. This coordination is essential at the policy and funding level as well. Traditionally, investigative teams aligned themselves with funders to test hypotheses specific to one band within the translational science spectrum. For example, grant support for a particular project may be more appropriate for one NIH institute compared to another. There are many examples of shared funding and coordinated efforts, however, by and large, constituencies have built up and established ‘guilds’ to assure that investigations are supported within specific disciplines. Federal agencies, industry, foundations, non-governmental organizations, universities, and other nations all have a broader or narrower approach to translation, depending on their primary interests (see figure). Figure Agency, Industry, Foundations, and Academic distribution along the translational science spectrum. Investigators and businesses frequently find the necessary collaborators and partners to assemble the necessary teams that effectively address problems of shared interest, no matter where they are in the world. So why shouldn’t this be encouraged more actively and achieved more readily among branches of the Federal Government? One example, within the National Institutes of Health (NIH), that could take advantage of shared programming, common goal setting, and evaluation includes the Clinical and Translational Science Award (CTSA) Program (managed through the National Center for Advancing Translational Science [NCATS]) and the Institutional Development Award (IDeA) Program Infrastructure for Clinical and Translational Research (IDeA-CTR – managed through the National Institute for General Medical Sciences [NIGMS]). Both the CTSAs and IDeA-CTRs have shared goals of advancing Translational Science, training future generations of investigators, and engaging the community in setting research priorities and implementing health changes. Exciting examples of interagency cooperation include several NIH-Food and Drug Administration (FDA) collaborations, the initiative between the National Institute on Aging (NIA) and Patient Centered Outcomes Research Institute (PCORI) to launch a Falls Injuries Prevention Project, and the Clinical Trials Transformation Initiative (CTTI). The NIA-PCORI Falls Injuries Prevention Project is a large clinical trial to test individually tailored interventions to prevent fall-related injuries, a major source of disability and loss of independence among older adults. Initiated in June 2014, this large randomized controlled trial includes well over 100 investigators in 10 geographically dispersed sites around the country who will enroll 6,000 older persons with modifiable risk factors for falling. The study was designed with input from the network of NIA supported Older American Independence Centers, dedicated to conducting translational research that promotes the health and welfare of the elderly – another example utilizing collaborative expertise. Subjects will receive either a personalized fall risk reduction program or usual care in this trial with falls and disability as major outcomes. The project was awarded and administered by the NIA with funding support from PCORI. From PCORI’s perspective, this trial will develop evidence, using patient and stakeholder input, to inform the Center for Medicare and Medicaid Services about what can feasibly be accomplished to maintain independence and improve health in older adults. The results will inform policy and encourage health care providers and systems to incorporate what’s learned into active practice. The FDA strategic plan to advance regulatory science was developed in 2011 with the vision of working with diverse partners to protect and promote health. The NIH is a key partner with the FDA in this initiative and both agencies sponsored a collaborative contract request for applications in 2010, ‘Advancing Regulatory Science through Novel Research and Science-Based Technologies’ (RFA-RM-10-006). To date, two awards have been made under this mechanism: one to the University of Michigan to accelerate drug and device evaluation through innovative clinical trial design; the second to Washington University for characterization and bioinformatics modeling of nano-particle complement interactions. Another important example of NIH-FDA partnerships is in managing the Tobacco Regulatory Science Program. Operating through the NIH Office of Disease Prevention, the program coordinates trans-NIH collaborative efforts with the FDA’s Center for Tobacco Products. FDA’s regulatory authority will be better informed through an evidence-base developed by NIH biomedical, behavioral and social science. In this program, FDA is providing the research funding through NIH mechanisms. The CTTI is a multi-faceted partnership involving more than 60 organizations to improve the quality and efficiency of clinical trials. As examples, the collaboration includes stakeholder representatives from the patient groups, FDA, Center for Medicare and Medicaid Services, NIH, industry (pharmaceutical, device, clinical research organizations), academic institutions, and professional societies. Established in 2008 between the FDA and Duke University, CTTI seeks to identify and analyze the barriers to efficient clinical trial conduct and then develop, test, and implement solutions. Recently, the CTTI collaborative received a multi-million dollar award, funded by the FDA to develop cross-cutting administrative and scientific structures and projects for all CTTI projects. The long-term outcomes are continual process improvements to increase the efficiency of clinical trials, obtaining the necessary outcome data in as cost-effective way and more rapidly allowing regulators to make decisions about whether the new therapy can be safely disseminated and implemented. The Association for Clinical and Translational Sciences (ACTS) applauds these coordinated efforts within and among federal agencies, industry, academia, and patient groups to create shared resources and methods for more rapidly determining which innovations effectively improve health. ACTS supports all clinical and translational scientists where ever they are working, without regard to which part of the translational spectrum or which organization they happen to reside professionally. The more freely organizations and investigative teams are encouraged to leverage and share resources to work towards common goals, the greater the chances for meaningful outcomes for the patients and communities we serve.