Northwest Arkansas, particularly Benton and Washington counties, is one of the highest COVID-19 hot spots in the United States (US), with more than half of all reported cases in this area identifying as Latinx or Pacific Islander, even though these communities account for less than 20% of the overall population. The University of Arkansas for Medical Sciences (UAMS) leveraged their existing relationship with 18 key community partners. Partners collaboratively developed a COVID-19 Response Strategy to ensure coordinated effort for Latinx and Pacific Islander communities with four interrelated strategies: health education, testing, contact tracing, and supported quarantine/case management.

Availability of trained professionals to assist researchers navigating regulatory pathways for new drug and device development is limited within academic institutions. We created ReGARDD (Regulatory Guidance for Academic Research of Drugs and Devices), a regional forum initially involving regulatory professionals from four Clinical and Translational Science Award (CTSA)-funded institutions, to build and capitalize on local expertise and to develop a regulatory guidance website geared toward academic researchers. Since 2015, members organized 15 forums covering topics such as FDA premarket submissions, gene therapy, and intellectual property for devices and therapeutics. Through user feedback, targeted surveys, and ongoing iterative processes, we refined and maintained a shared regulatory website, which reached 6000+ users in 2019. Website updates improved navigation to drug versus device topic areas, provided new educational content and videos to address commonly asked questions, and created a portal for posting upcoming training opportunities. Survey respondents rated the website favorably and endorsed expanding ReGARDD as a centralized resource. ReGARDD strengthened the regional regulatory workforce, increased regulatory efficiency, and promulgated best organizational and operational practices. Broad-scale deployment of the ReGARDD model across the CTSA consortium may facilitate the creation of a network of regional forums and reduce gaps in access to regulatory support.

Leadership is an essential competency for clinicians; however, these skills are not a standard part of health professionals’ education and training. Access to resources (time, money) is frequently cited as a barrier for clinicians to participate in leadership development programs. We aimed to tackle this barrier within postgraduate health professions education and training through establishing an online e-Leadership Academy. The e-Leadership Academy was developed as a community–academic partnership between Clinical Directors Network, Inc. (CDN) and the Harvard Medical School Center for Primary Care to train clinicians and healthcare staff in the fundamental concepts and skills for leading within a clinical practice. For this article, the primary outcome analysis examined participants’ responses to both formative and summative evaluations that took place throughout and at the end of the course. Results were used to assess course quality, participant satisfaction, participant engagement, and provide recommendations about future course offerings for a similar audience. The authors propose that future training programs could measure the changes in team behavior and clinical outcomes using expanded evaluations. Proposed plans for expansion of the e-Leadership Academy include developing additional modules, virtual coaching and mentoring, and the potential integration of an in-person component.

The Motivation Assessment for Team Readiness, Integration, and Collaboration (MATRICx) is a psychometric instrument that measures individual motivation for collaboration. It was validated using Rasch Analysis to create an indicator hierarchy on two dimensions: cooperation and collaboration. Six domains provide the basis for the tool to identify team member readiness for collaboration and a means by which to understand motivational strengths in a team based on degree of past self-reported experience. This brief report provides an overview of the development of the tool, how science teams may use it, and how to interpret results to advance team member readiness for greater collaboration. The paper also draws attention to ongoing work in progress to develop learning interventions to accompany the MATRICx instrument.

Understanding place-based contributors to health requires geographically and culturally diverse study populations, but sharing location data is a significant challenge to multisite studies. Here, we describe a standardized and reproducible method to perform geospatial analyses for multisite studies. Using census tract-level information, we created software for geocoding and geospatial data linkage that was distributed to a consortium of birth cohorts located throughout the USA. Individual sites performed geospatial linkages and returned tract-level information for 8810 children to a central site for analyses. Our generalizable approach demonstrates the feasibility of geospatial analyses across study sites to promote collaborative translational research.

Engaging communities can increase the speed of translating health and health equity research into practice. Effective engagement requires a shared understanding of the health of a community. This can be challenging without timely and accurate local health data, or ways to provide that data, that are directly applicable to improving community health outcomes. The University of Wisconsin Institute for Clinical and Translational Research formed the Neighborhood Health Partnerships Program (NHP) to overcome this challenge, making sub-county health data available to researchers and community stakeholders while incorporating community voice into data delivery processes. The NHP team used a human-centered design approach to facilitate community engagement. Through co-design, the team created NHP reports and data-to-action tools to maximize accessibility and utility for a diverse set of community stakeholders. Early indicators show that the final co-designed NHP reports and data-to-action tools will be immediately useful in promoting community–academic partnerships and in planning, implementing, and evaluating research and other initiatives in communities. The NHP program demonstrates that an effective co-design strategy can lead to increased usability and adoption of Clinical and Translational Science Award resources, enabling a shared understanding of community health and ultimately leading to the successful translation of research into practice.

Traditional training and funding mechanisms in academic health centers often do not support its faculty, staff, and trainees in evaluating and implementing innovative ideas, necessitating supplemental innovation programming. The University of Michigan (U-M) Frankel Cardiovascular Center partnered with U-M Fast Forward Medical Innovation (FMMI), a biomedical innovation and commercialization unit funded in part by the Clinical and Translational Science Award awarded to the Michigan Institute for Clinical & Health Research, to provide training and resources to advance ideas toward impacting patients. The program recruited faculty, trainees, staff, patients, and family members from multidisciplinary backgrounds. Engaging patients and family members expanded the ideas generated and furthered clinical relevance. Over two years, 11 project teams completed an 11-week, 16-session course on innovation and entrepreneurship concepts that incorporated workshops to progress ideas and develop a pitch for development funding. An increase in knowledge was reported in key innovation topics, such as customer discovery, assessing markets, and intellectual property. Participants reported an increase in project preparation, including obtaining stakeholder support, preparation of a development plan, readiness to apply for funding, and filing invention disclosures. This program can serve as a model for implementing training and funding mechanisms to advance innovative ideas.

Biospecimen repositories play a vital role in enabling investigation of biologic mechanisms, identification of disease-related biomarkers, advances in diagnostic assays, recognition of microbial evolution, and characterization of new therapeutic targets for intervention. They rely on the complex integration of scientific need, regulatory oversight, quality control in collection, processing and tracking, and linkage to robust phenotype information. The COVID-19 pandemic amplified many of these considerations and illuminated new challenges, all while academic health centers were trying to adapt to unprecedented clinical demands and heightened research constraints not witnessed in over 100 years. The outbreak demanded rapid understanding of SARS-CoV-2 to develop diagnostics and therapeutics, prompting the immediate need for access to high quality, well-characterized COVID-19-associated biospecimens. We surveyed 60 Clinical and Translational Science Award (CTSA) hubs to better understand the strategies and barriers encountered in biobanking before and in response to the COVID-19 pandemic. Feedback revealed a major shift in biorepository model, specimen-acquisition and consent process from a combination of investigator-initiated and institutional protocols to an enterprise-serving strategy. CTSA hubs were well equipped to leverage established capacities and expertise to quickly respond to the scientific needs of this crisis through support of institutional approaches in biorepository management.

Rapid development and deployment of diagnostic testing for COVID-19 have been a key component of the public health response to the pandemic. Out of necessity, academic and other clinical laboratories developed laboratory testing innovations for COVID-19 to meet clinical testing demands. In addition to constraints on local testing supplies and equipment, a rapidly changing regulatory framework created challenges for translational scientists. Illustrative examples of approaches used to develop laboratory tests during the early stages of the COVID-19 pandemic demonstrate effective team science approaches to this challenging clinical care and public health emergency. These experiences and the associated lessons learned are relevant to the development of public health response plans for future pandemics.

Efforts to move community engagement in research from marginalized to mainstream include the NIH requiring community engagement programs in all Clinical and Translational Science Awards (CTSAs). However, the COVID-19 pandemic has exposed how little these efforts have changed the dominant culture of clinical research. When faced with the urgent need to generate knowledge about prevention and treatment of the novel coronavirus, researchers largely neglected to involve community stakeholders early in the research process. This failure cannot be divorced from the broader context of systemic racism in the US that has contributed to Black, Indigenous, and People of Color (BIPOC) communities bearing a disproportionate toll from COVID-19, being underrepresented in COVID-19 clinical trials, and expressing greater hesitancy about COVID-19 vaccination. We call on research funders and research institutions to take decisive action to make community engagement obligatory, not optional, in all clinical and translational research and to center BIPOC communities in this process. Recommended actions include funding agencies requiring all research proposals involving human participants to include a community engagement plan, providing adequate funding to support ongoing community engagement, including community stakeholders in agency governance and proposal reviews, promoting racial and ethnic diversity in the research workforce, and making a course in community engaged research a requirement for Masters of Clinical Research curricula.

The 2020 COVID-19 pandemic has had a profound impact on the clinical research enterprises at the 60 Clinical and Translational Science Award (CTSA) Hubs throughout the nation. There was simultaneously a need to expand research to obtain crucial data about disease prognosis and therapy and enormous limitations on conducting research as localities and institutions limited travel and person-to-person contact. These imperatives resulted in major changes in the way research was conducted, including expediting Institutional Review Board review, shifting to remote interactions with participants, centralizing decision-making in prioritizing research protocols, establishing biobanks, adopting novel informatics platforms, and distributing study drugs in unconventional ways. National CTSA Steering Committee meetings provided an opportunity to share best practices and develop the idea of capturing the CTSA program experiences in a series of papers. Here we bring together the recommendations from those papers in a list of specific actions that research sites can take to strengthen operations and prepare for similar future public health emergencies. Most importantly, creative innovations developed in response to the COVID-19 pandemic deserve serious consideration for adoption as new standards, thus converting the painful trauma of the pandemic into “post-traumatic growth” that makes the clinical research enterprise stronger, more resilient, and more effective.

The COVID-19 pandemic has led to major disruptions in the clinical research enterprise. Investigators and staff at the University of Washington and Seattle Children’s Research Institute (SCRI) were surveyed to determine the impact of the pandemic restrictions on their non-COVID-19 clinical research studies. Enrollment and study visits were stopped for over half of the interventional trials. There were both positive and negative impacts of the work restrictions on the professional and personal lives of faculty and staff. Academic and research institutions should consider how best to support investigators and their teams during this pandemic.

Over the last year, COVID-19 has emerged as a highly transmissible and lethal infection. As we address this global pandemic, its disproportionate impact on Black, Indigenous, and Latinx communities has served to further magnify the health inequities in access and treatment that persist in our communities. These sobering realities should serve as the impetus for reexamination of the root causes of inequities in our health system. An increased commitment to strategic partnerships between academic and nonacademic health systems, industry, local communities, and policy-makers may serve as the foundation. Here, we examine the impact of the recent COVID-19 pandemic on health care inequities and propose a strategic roadmap for integration of clinical and translational research into our understanding of health inequities.