A robust biomedical informatics infrastructure is essential for academic health centers engaged in translational research. There are no templates for what such an infrastructure encompasses or how it is funded. An informatics workgroup within the Clinical and Translational Science Awards network conducted an analysis to identify the scope, governance, and funding of this infrastructure. After we identified the essential components of an informatics infrastructure, we surveyed informatics leaders at network institutions about the governance and sustainability of the different components. Results from 42 survey respondents showed significant variations in governance and sustainability; however, some trends also emerged. Core informatics components such as electronic data capture systems, electronic health records data repositories, and related tools had mixed models of funding including, fee-for-service, extramural grants, and institutional support. Several key components such as regulatory systems (e.g., electronic Institutional Review Board [IRB] systems, grants, and contracts), security systems, data warehouses, and clinical trials management systems were overwhelmingly supported as institutional infrastructure. The findings highlighted in this report are worth noting for academic health centers and funding agencies involved in planning current and future informatics infrastructure, which provides the foundation for a robust, data-driven clinical and translational research program.

In this report, we describe the implementation and short-term outcomes of a Special Populations Consultation Service within the University of California, Los Angeles (UCLA) Clinical and Translational Science Institute (CTSI). With the goal of increasing the quality and quantity of special population (SP) research, the UCLA CTSI Integrating Special Populations program designed a consultation service to support faculty and trainees conducting research involving one of three CTSI “special populations:” children, older adults, and/or minority; underserved; or health disparity populations. The Special Populations Consultation Service offers three types of activities: grant proposal studios, career consultations, and project reviews. UCLA CTSI faculty with appropriate content expertise serve as consultants. We evaluated this consultation model using satisfaction surveys and by quantifying funded grants and reported changes in career goals in SP research. Between 2016 and 2019, the Special Populations Consultation Service provided 59 consultations including 42 grant studios and was used by researchers at all levels from all four UCLA CTSI institutions. Recipients rated the consultations very highly. Funding success rates were 57% following K-level grant studios and 28% following R-level grant studios. Users of project and career consultations commonly attributed career accomplishments in part to their consultation experiences. The SP Consultation Service is feasible and acceptable and appears to enhance careers of investigators studying special populations.

Clinical and translational science is vitally dependent on the nation’s underlying health-care policies and programs. In a reciprocal fashion, data generated by clinical and translational research can inform both health policy and health-care delivery. It is important, therefore, to rate health reform proposals comprehensively on a set of criteria that reflect the broad goals of reform, including the potential impact on clinical and translational science and medical education. I propose that the criteria include achieving universal coverage, reducing administrative costs, retaining one’s chosen primary care physician, encouraging care coordination, empowering physicians, freeing industry from choosing and administering health plans, providing choice of specialists and hospitals, providing patient education, preventing patient overuse of services, rationalizing resource allocation, encouraging competition, limiting government’s role, supporting medical education, training, and research, and freeing industry to make personnel decisions based on business criteria rather than the impact on health-care costs to the company. I discuss the rationale for each element and offer a rating of current proposals relative to a proposal previously made.

A number of publications have discussed approaches to training the scientific workforce in comparative effectiveness research (CER) and patient-centered outcomes research (PCOR). To meet this need, funders have offered resources for developing educational materials and establishing training programs. To extend these efforts into specific researcher communities, the Agency for Healthcare Research and Quality developed an R25 Funding Opportunity Announcement that called for basic, advanced, and experiential training for a specific researcher community in collaboration with associated program partners. This paper describes the strategies developed by the 5 subsequently funded programs, their specific researcher communities and program partners, and the challenges associated with developing in-person and online programs. We focus on lessons learned that can be translated into developing training programs nationwide and on training for the special populations of interest. We also discuss the creation of a sustainable network for training and the conduct of comparative effectiveness research/patient-centered outcomes research in targeted communities.

Childhood obesity is a complex and multi-faceted problem, with contributors ranging from individual health behaviors to public policy. For clinicians who treat pediatric obesity, environmental factors that impact this condition in a child or family can be difficult to address in a clinical setting. Community-clinic partnerships are one method to address places and policies that influence a person’s weight and health; however, such partnerships are typically geared toward community-located health behavior change rather than the deeper social determinants of health (SDH), limiting effective behavioral change. Community-engaged research offers a framework for developing community-clinic partnerships to address SDH germane to obesity treatment. In this paper, we discuss the relationship between SDH and pediatric obesity treatment, use of community-clinic partnerships to address SDH in obesity treatment, and how community engagement can be a framework for creating and harnessing these partnerships. We present examples of programs begun by one pediatric obesity clinic using community-engagement principles to address obesity.

Partnered research may help bridge the gap between research and practice. Community-based participatory research (CBPR) supports collaboration between scientific researchers and community members that is designed to improve capacity, enhance trust, and address health disparities. Systems science aims to understand the complex ways human-ecological coupled systems interact and apply knowledge to management practices. Although CBPR and systems science display complementary principles, only a few articles describe synergies between these 2 approaches. In this article, we explore opportunities to utilize concepts from systems science to understand the development, evolution, and sustainability of 1 CBPR partnership: The Community Health Advocacy and Research Alliance (CHARA). Systems science tools may help CHARA and other CBPR partnerships sustain their core identities while co-evolving in conjunction with individual members, community priorities, and a changing healthcare landscape. Our goal is to highlight CHARA as a case for applying the complementary approaches of CBPR and systems science to (1) improve academic/community partnership functioning and sustainability, (2) ensure that research addresses the priorities and needs of end users, and (3) support more timely application of scientific discoveries into routine practice.

Twelve evidence-based profiles of roles across the translational workforce and two patients were made available through clinical and translational science (CTS) Personas, a project of the Clinical and Translational Science Awards (CTSA) Program National Center for Data to Health (CD2H). The persona profiles were designed and researched to demonstrate the key responsibilities, motivators, goals, software use, pain points, and professional development needs of those working across the spectrum of translation, from basic science to clinical research to public health. The project’s goal was to provide reliable documents that could be used to inform CTSA software development projects, educational resources, and communication initiatives. This paper presents the initiative to create personas for the translational workforce, including the methodology, engagement strategy, and lessons learned. Challenges faced and successes achieved by the project may serve as a roadmap for others searching for best practices in the creation of Persona profiles.

This paper proposes the creation and application of maturity models to guide institutional strategic investment in research informatics and information technology (research IT) and to provide the ability to measure readiness for clinical and research infrastructure as well as sustainability of expertise. Conducting effective and efficient research in health science increasingly relies upon robust research IT systems and capabilities. Academic health centers are increasing investments in health IT systems to address operational pressures, including rapidly growing data, technological advances, and increasing security and regulatory challenges associated with data access requirements. Current approaches for planning and investment in research IT infrastructure vary across institutions and lack comparable guidance for evaluating investments, resulting in inconsistent approaches to research IT implementation across peer academic health centers as well as uncertainty in linking research IT investments to institutional goals. Maturity models address these issues through coupling the assessment of current organizational state with readiness for deployment of potential research IT investment, which can inform leadership strategy. Pilot work in maturity model development has ranged from using them as a catalyst for engaging medical school IT leaders in planning at a single institution to developing initial maturity indices that have been applied and refined across peer medical schools.

The mission of the National Center for Advancing Translational Science (NCATS) is to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.1 NCATS funded a predoctoral TL1 training grant at our institution. We developed a novel team-based Translational Journal Club utilizing three-member teams to find a basic science paper and two clinical study papers that covered a single therapeutic, either a pivotal study or a dissemination and implementation study; one member of the team presented a paper on the above topics in successive weeks. In addition, the trainees attended lectures on: how to design a pivotal clinical trial, dissemination and implementation, and drug development from a basic science discovery through its approval. From these presentations, the trainees appreciated the T0 to T3/4 continuum and its challenges. They also attended sessions on how to present scientific concepts, making them better communicators. The trainees found the Translational Journal club to be very rewarding, illuminating, and providing a much better understanding of the translational research processes required to develop new therapies.

The Indiana Clinical and Translational Sciences Institute’s Community Engagement Partners-Purdue Extension collaborative model demonstrates tremendous potential for creating state-wide programmatic efforts and improvements in both the health culture and status of Indiana residents across the state. It can serve as a prototype not only for others interested in pursuing wide geographic health improvements through Clinical and Translational Sciences Award-Cooperative Extension partnerships but also for broader collaborations among United States Department of Agriculture, National Institutes of Health, Centers for Disease Control and Prevention, state and local health departments, and health foundation efforts to improve population health.

Academic medical centers (AMCs) face challenges in conducting research among traditionally marginalized communities due to long-standing community mistrust. Evidence suggests that some AMC faculty and staff lack an understanding of the history of distrust and social determinants of health (SDH) affecting their communities. Wake Forest Clinical and Translational Science Institute Program in Community Engagement (PCE) aims to build bridges between communities and Wake Forest Baptist Health by equipping faculty, clinicians, administrators, and staff (FCAS) with a better understanding of SDH. The PCE collaborated with community partners to develop and implement community tours to improve cross-community AMC understanding and communication, enhance knowledge of SDH, and build awareness of community needs, priorities, and assets. Nine day-long tours have been conducted with 92 FCAS. Tours included routes through under-resourced neighborhoods and visits to community assets. Participant evaluations assessed program quality; 89% reported enhanced understanding of access-to-care barriers and how SDH affect health; 86% acknowledged the experience would improve future interactions with participants and patients; and 96% agreed they would recommend the tour to colleagues. This work supports the use of community tours as a strategy to improve cross-community AMC communication, build trust, and raise awareness of community needs, priorities, and assets.

Building on the recent advances in next-generation sequencing, the integration of genomics, proteomics, metabolomics, and other approaches hold tremendous promise for precision medicine. The approval and adoption of these rapidly advancing technologies and methods presents several regulatory science considerations that need to be addressed. To better understand and address these regulatory science issues, a Clinical and Translational Science Award Working Group convened the Regulatory Science to Advance Precision Medicine Forum. The Forum identified an initial set of regulatory science gaps. The final set of key findings and recommendations provided here address issues related to the lack of standardization of complex tests, preclinical issues, establishing clinical validity and utility, pharmacogenomics considerations, and knowledge gaps.