Early in the COVID-19 pandemic, the World Health Organization stressed the importance of daily clinical assessments of infected patients, yet current approaches frequently consider cross-sectional timepoints, cumulative summary measures, or time-to-event analyses. Statistical methods are available that make use of the rich information content of longitudinal assessments. We demonstrate the use of a multistate transition model to assess the dynamic nature of COVID-19-associated critical illness using daily evaluations of COVID-19 patients from 9 academic hospitals. We describe the accessibility and utility of methods that consider the clinical trajectory of critically ill COVID-19 patients.

Low-accruing clinical trials delay translation of research breakthroughs into the clinic, expose participants to risk without providing meaningful clinical insight, increase the cost of therapies, and waste limited resources. By tracking patient accrual, Clinical and Translational Science Awards hubs can identify at-risk studies and provide them the support needed to reach recruitment goals and maintain financial solvency. However, tracking accrual has proved challenging because relevant patient- and protocol-level data often reside in siloed systems. To address this fragmentation, in September 2020 the South Carolina Clinical and Translational Research Institute, with an academic home at the Medical University of South Carolina, implemented a clinical trial management system (CTMS), with its access to patient-level data, and incorporated it into its Research Integrated Network of Systems (RINS), which links study-level data across disparate systems relevant to clinical research. Within the first year of CTMS implementation, 324 protocols were funneled through CTMS/RINS, with more than 2600 participants enrolled. Integrated data from CTMS/RINS have enabled near-real-time assessment of patient accrual and accelerated reimbursement from industry sponsors. For institutions with bioinformatics or programming capacity, the CTMS/RINS integration provides a powerful model for tracking and improving clinical trial efficiency, compliance, and cost-effectiveness.

The coronavirus disease 2019 (COVID-19) pandemic requires urgent implementation of effective community-engaged strategies to enhance education, awareness, and inclusion of underserved communities in prevention, mitigation, and treatment efforts. The Texas Community-Engagement Alliance Consortium was established with support from the United States’ National Institutes of Health (NIH) to conduct community-engaged projects in selected geographic locations with a high proportion of medically underserved minority groups with a disproportionate burden of COVID-19 disease and hospitalizations. The purpose of this paper is to describe the development of the Consortium. The Consortium organized seven projects with focused activities to address COVID-19 clinical and vaccine trials in highly affected counties, as well as critical statewide efforts. Five Texas counties (Bexar, Dallas, Harris, Hidalgo, and Tarrant) were chosen by NIH because of high concentrations of underserved minority communities, existing community infrastructure, ongoing efforts against COVID-19, and disproportionate burden of COVID-19. Policies and practices can contribute to disparities in COVID-19 risk, morbidity, and mortality. Community engagement is an essential element for effective public health strategies in medically underserved minority areas. Working with partners, the Consortium will use community engagement strategies to address COVID-19 disparities.

There are numerous examples of translational science innovations addressing challenges in the translational process, accelerating progress along the translational spectrum, and generating solutions relevant to a wide range of human health needs. Examining these successes through an education lens can identify core principles and effective practices that lead to successful translational outcomes. The National Center for Advancing Translational Sciences (NCATS) is identifying and teaching these core principles and practices to a broad audience via online courses in translational science which teach from case studies of NCATS-led or supported research initiatives. In this paper, we share our approach to the design of these courses and offer a detailed description of our initial course, which focused on a preclinical drug discovery and development project spanning academic and government settings. Course participants were from a variety of career stages and institutions. Participants rated the course high in overall value to them and in providing a unique window into the translational science process. We share our model for course development as well as initial findings from the course evaluation with the goal of continuing to stimulate development of novel education activities teaching foundational principles in translational science to a broad audience.

The African American population of Buffalo, New York experiences striking race-based health disparities due to adverse social determinants of health. A team of community leaders and university faculty determined that a community dialogue was needed to focus research and advocacy on the root causes of these disparities. In response, we organized the annual Igniting Hope conference series that has become the premier conference on health disparities in the region. The series, now supported by an R13 conference grant from NCATS, has been held four times (2018–2021) and has attracted community members, community leaders, university faculty, and trainees. The agenda includes talks by national leaders and breakout/working groups that led to a new state law that has reduced disproportionate traffic-ticketing and drivers' license suspensions in Black neighborhoods; mitigation of the disproportionate COVID-19 fatalities in Black communities; and the launching of a university-supported institute. We describe the key elements of success for a conference series designed by a community–university partnership to catalyze initiatives that are having an impact on social determinants of health in Buffalo.

Identifying and disseminating actionable intelligence is a challenging task that requires thoughtful planning. The National Center for Advancing Translational Sciences instituted the Common Metrics Initiative with the goal of evaluating the Clinical and Translational Science Awards (CTSA) Programs using a standard set of metrics. Initially managed by Tufts University, the Center for Leading Innovation and Collaboration (CLIC) at the University of Rochester began leading this initiative in 2017. In directing this work, CLIC created a framework for communicating and disseminating data insights. Insights to Inspire emerged from the need to share strategies and lessons learned to improve metric performance at the local level to a network of 60+ academic research institutions. Insights to Inspire employs a mixed methods approach for translating data into actionable intelligence. A series of blogs, webinars, and webcasts were designed to communicate metric-specific strategies used by individual sites to the broader CTSA consortium. A dissemination plan to expand the reach beyond metric stakeholders utilized focused communications including social media channels, network newsletters, and presentations at national meetings. This framework serves as a blueprint for other national evaluation programs interested in a systematic approach to using data insights for continuous improvement.

Electronic platforms provide an opportunity to improve the informed consent (IC) process by permitting elements shown to increase research participant understanding and satisfaction, such as graphics, self-pacing, meaningful engagement, and access to additional information on demand. However, including these elements can pose operational and regulatory challenges for study teams and institutional review boards (IRBs) responsible for the ethical conduct and oversight of research. We examined the experience of two study teams at Alzheimer’s Disease Research Centers who chose to move from a paper-based IC process to an electronic informed consent (eIC) process to highlight some of these complexities and explore how IRBs and study teams can navigate them. Here, we identify the key regulations that should be considered when developing and using an eIC process as well as some of the operational considerations eIC presents related to IRB review and how they can be addressed.

Despite the disproportionate burden of Alzheimer’s disease in older adults of color, the scientific community continues to grapple with underrepresentation of racial and ethnic minorities in clinical research. Our Center of Excellence for Alzheimer’s Disease (CEAD) collaborated with a local community partner to conduct community engagement (CE) studios to effectively involve our community of diverse older adults in the early planning stages of a clinical trial. Given the COVID-19 pandemic, the in-person studio format was adapted to allow for virtual, real-time participation. Our objective is to describe the process and feasibility of conducting virtual CE studios in an older adult population. Ninety percent of participants were non-Hispanic Black community-dwelling woman aged 60 years and older. The overall background and proposed clinical trial design was presented to the participants who then made recommendations regarding potential recruitment strategies, the use of culturally relevant language to describe the study, and logistical recommendations to improve participation and retention among community members. Our CEAD successfully conducted virtual CE studios during the COVID-19 pandemic, by partnering with a community-based organization, to engage community stakeholders about clinical trial design. CEADs are in a unique position to implement CE studios to better support patient access to clinical trials.

As the USA and the rest of the world raced to fight the COVID-19 pandemic, years of investments from the National Center for Advancing Translational Sciences allowed for informatics services and resources at CTSA hubs to play a significant role in addressing the crisis. CTSA hubs partnered with local and regional partners to collect data on the pandemic, provide access to relevant patient data, and produce data dashboards to support decision-making. Coordinated efforts, like the National COVID Cohort Collaborative (N3C), helped to aggregate and harmonize clinical data nationwide. Even with significant informatics investments, some CTSA hubs felt unprepared in their ability to respond to the fast-moving public health crisis. Many hubs were forced to quickly evolve to meet local needs. Informatics teams expanded critical support at their institutions which included an engagement platform for clinical research, COVID-19 awareness and education activities in the community, and COVID-19 data dashboards. Continued investments in informatics resources will aid in ensuring that tools, resources, practices, and policies are aligned to meet local and national public health needs.

Retrospective case studies of initiatives supported by the National Institutes of Health’s Clinical and Translational Science Award (CTSA) hubs can be used to identify facilitators and barriers of translational science. This case study investigates how a CTSA Expanded Access program adapted to changing FDA guidance issued in 2020 to support clinicians’ treatment of COVID-19 patients in Michigan. We studied how this program changed throughout the pandemic to support physicians’ requests for remdesivir, convalescent plasma, and other uses of unapproved drugs and novel medical devices. A protocol for retrospective translational science case studies of health interventions developed by CTSA evaluators was used for this case study. Data collection methods included seven interviews and a review of institutional data, peer-reviewed publications, news stories, and other public records. The barriers identified include evolving guidance, misalignment of organizational operations, and the complexity of the research infrastructure. The facilitators of translation include collaboration between research and care teams, increasing engagement with a broad network of supporters, and ongoing professional development for research staff. The findings of this case study can be used to inform future investigations of the principles underlying the translational process.

In recent years, there have been concerted efforts to better recruit, support, and retain diverse faculty, staff, and trainees in academic medicine. However, many institutions lack comprehensive and strategic plans to provide support to retain and recruit individuals from historically underrepresented groups. In this article, we itemize specific mechanisms through which institutions can support diverse individuals with the goal of improving inclusion and belonging in the workforce to better reflect the diversity of the intended patient and research participant population.