The internal research program of the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health aims to fundamentally transform the preclinical translational research process to get more treatments to more people more quickly. The program develops and implements innovative scientific and operational approaches that accelerate and enhance translation across many diverse projects. Cross-disciplinary team science is a defining feature of our organization, with scientists at all levels engaged in multiple research teams. Here, we share our systems approach to nurturing cross-disciplinary team science, which leverages organizational policies, structures, and processes. Policies including the organizational mission statement, principles for ethical conduct of research, performance review criteria, and training program objectives and approaches reinforce the value of team science to achieve the program’s scientific goals. Structures including an organizational structure designed around solving translational problems, co-location of employees in a single state-of-the-art scientific facility, and shared-use laboratories, expertise and instrumentation facilitate collaboration. Processes including fluid team assembly, specialized project management, cross-agency partnerships, and decision making based on clear screening criteria and milestones enable effective team assembly and functioning. We share evidence of the impact of these approaches on the science and commercialization of findings and discuss pathways to broad adoption of similar approaches.

The ability to effectively lead an interdisciplinary translational team is a crucial component of team science success. Most KL2 Clinical Scholars have been members of scientific teams, but few have been team science leaders. There is a dearth of literature and outcome measures of effective Team Science Leadership in clinical and translational research. We focused our curriculum to emphasize Team Science Leadership, developed a list of Team Science Leadership competencies for translational investigators using a modified Delphi method, and incorporated the competencies into a quantitative evaluation survey. The survey is completed on entry and annually thereafter by the Scholar; the Scholar’s primary mentor and senior staff who educate and interact with the Scholar rate the Scholar at the end of each year. The program leaders and mentor review the results with each Scholar. The survey scales had high internal consistency and good factor structure. Overall ratings by mentors and senior staff were generally high, but ratings by Scholars tended to be lower, offering opportunities for discussion and career planning. Scholars rated the process favorably. A Team Science Leadership curriculum and periodic survey of attained competencies can inform individual career development and guide team science curriculum development.

Few studies have explored the challenges that the COVID-19 pandemic has presented for Clinical Research Units (CRUs), the solutions that have been implemented, and the changes that have been made in the operational guidelines for these entities. This study sought to identify and document common practices implemented by CRUs around the United States of America (USA) when addressing the unique challenges posed by the COVID-19 pandemic. This descriptive study utilized a non-experimental mixed-methods approach and gathered data from representatives of 43 CRUs across the USA. An online survey was followed by in-depth interviews. The findings show that challenges faced from the COVID-19 pandemic, changes made to daily operations, and lessons learned are very similar across CRUs. Although most CRUs never stopped performing essential clinical research, many adapted to the pandemic by engaging in virtual visits, and many played key roles in administering and supporting both COVID-19 therapeutic and vaccine trials. Follow-up interviews showed that processes for formal approval and reopening were similar across CRUs. In addition to highlighting the significance of the role played by CRUs during the COVID-19 pandemic, this study addresses the relevance of CRUs and lays the groundwork for future conversations on the importance of these units.

Demand for building competencies in implementation research (IR) outstrips supply of training programs, calling for a paradigm shift. We used a bootstrap approach to leverage external resources and create IR capacity through a novel 2-day training for faculty scientists across the four Texas Clinical & Translational Science Awards (CTSAs). The Workshop combined internal and external expertise, targeted nationally established IR competencies, incorporated new National Institutes of Health/National Cancer Institute OpenAccess online resources, employed well-known adult education principles, and measured impact. CTSA leader buy-in was reflected in financial support. Evaluation showed increased self-reported IR competency; statewide initiatives expanded. The project demonstrated that, even with limited onsite expertise, it was possible to bootstrap resources and build IR capacity de novo in the CTSA community.

Diversity, equity, and inclusion (DEI) are fundamentally important concepts for advancing clinical and translational science (CTS) education. CTS education spans a wide range of disciplines from cell biology to clinical and community/population research. This large scope both in terms of intellectual areas and target groups requires an understanding of existing educational approaches for DEI as we translate DEI from mere concepts into equitable actions within CTS education. In this  review, we provide the readers with the most common DEI educational approaches, including cultural humility, bias training, and improving mentoring to diversify the workforce. DEI educational materials can achieve maximal success and long-term impact when implemented as institutional-wide interventions, and the materials are not seen as an isolated or independent curriculum. Approaches, strategies, and programs to achieve this are many. However, many questions remain unanswered about what the best approach, strategies, and programs are to be implemented in institutional-wide education that will be embedded in CTS education.

Diversity remains low among US colleges faculty, with only 3% identifying as Black or Hispanic. Moreover, underrepresented racial minority faculty often face unique challenges and are less likely than their white counterparts to earn higher academic rank, tenure, and funding, especially those who study health equity. We developed a novel program for health-equity focused pre-docs and junior faculty. The Disparities Researchers Equalizing Access for Minorities (DREAM) Scholars is a 24-month career development program led by the Center for Clinical and Translational Science (CCTS) that provides pilot and travel funding, career development seminars, mentoring, and writing retreats. We report the outcomes of the first Scholar cohort (N = 10), pre-docs n = 6; assistant professors, n = 4; seven were Black, one Hispanic, two White, one who identified as non-binary. At the end of the program, Scholars coauthored 34 manuscripts, 9 abstracts and 8 grants. Semi-structured interviews revealed seven major program strengths: funding, support and sense of community, accountability, exposure to translational science, network expansion, and exposure to multidisciplinary peers. Scholars provided feedback useful for subsequent cohorts. The DREAM program provided accountability and fostered a sense of community, expanded professional networks and enhanced scholarly productivity. The program serves as a model for implementation throughout the CCTSs.

NIH offers multiple mentored career development award mechanisms. By building on the UC Davis Clinical and Translational Science Center (CTSC) from its initial NIH funding in 2006, we created an institution-wide K scholar resource. We investigated subsequent NIH funding for K scholars and to what extent CTSC research resources were used. Using NIH RePORTER, we created a database of UC Davis investigators who obtained K01, K08, K23, K25, or K99, as well as institutional KL2 or K12 awards and tracked CTSC research resource use and subsequent funding success. Overall, 94 scholars completed K training between 2007 and 2020, of which 70 participated in one of four institutional, NIH-funded K programs. An additional 103 scholars completed a mentored clinical research training program. Of 94 K awardees, 61 (65%) later achieved NIH funding, with the majority receiving a subsequent individual K award. A higher proportion (73%) of funded scholars used CTSC resources compared to unfunded (48%). Biostatistics and Biomedical Informatics were most commonly used and 55% of scholars used one or more CTSC resource. We conclude that institutional commitment to create a K scholar platform and use of CTSC research resources is associated with high NIH funding rates for early career investigators.

Community engagement is a critical component of translational research. Innovative educational approaches to support meaningful involvement of stakeholders in clinical research allows for bidirectional learning and greater engagement in translational efforts. Our Penn State Community-Engaged Research Core (CeRC) team has developed an innovative research curriculum for a variety of stakeholders, including patient partners, organizational representatives, and Community Health Workers (CHWs). This brief report will outline unique curricular approaches, guided by adult learning principles, to enhance stakeholder education and engagement in activities. Initial evidence of impact on learning is also reported.

The learning sciences have yielded a wealth of insights about the mechanisms and conditions that promote learning, yet the findings from this body of research often do not make their way into educational practice. This fundamentally translational problem is one we believe that educators from translational fields, with their evidence-based orientation and familiarity with the challenges and importance of translation, are well-positioned to address. Here, we provide a primer on the learning sciences to guide educators in the Clinical and Translational Science Institutes and other organizations that train translational researchers. We (a) describe the unique teaching and learning environment in which this training occurs, and why it necessitates attention to learning research and its appropriate application, (b) explain what the learning sciences are, (c) distill the complex science of learning into core principles, (d) situate recent developments in the field within these principles, and (e) explain, in practical terms, how these principles can inform our teaching.

Underrepresented minorities have higher attrition from the professoriate and have experienced greater negative impacts of the COVID-19 pandemic. The purpose of this study was to compare the impact of COVID-19 on the lives of 196 early-career physician-scientists versus PhD researchers who are underrepresented in biomedical research. Participants in the Building Up study answered questions on the impact of the COVID-19 pandemic on their personal and professional lives, and a mixed-methods approach was used to conduct the analysis. While most participants experienced increases in overall stress (72% of PhD researchers vs 76% of physician-scientists), physician-scientists reported that increased clinical demands, research delays, and the potential to expose family members to SARS-CoV-2 caused psychological distress, specifically. PhD researchers, more than physician-scientists, reported increased productivity (27% vs 9%), schedule flexibilities (49% vs 25%), and more quality time with friends and family (40% vs 24%). Future studies should consider assessing the effectiveness of programs addressing COVID-19-related challenges experienced by PhD researchers and physician-scientists, particularly those from underrepresented backgrounds.

The NIH Center for Accelerated Innovations at Cleveland Clinic (NCAI-CC) was funded by the National Heart Lung and Blood Institute (NHLBI) to support academic investigators in technology development and commercialization. NCAI-CC was one of three multi-institutional Centers established in the fall of 2013. The goal of each Center was to catalyze the growth of an ecosystem of commercialization within their affiliated institutions and regions by managing a program of funding and guiding translational project development and by delivering commercialization education programs to participating investigators. NCAI-CC created and managed such a funding program, ultimately supporting 75 different projects across seven separate academic institutions and developed tailored educational content following the National Science Foundation I-Corps™ curriculum and delivered the program to 79 teams from 12 institutions. We determined early on that in establishment and implementation of projects, it is important to support the teams and principal investigators throughout the program. The support includes a change in principal investigator mindset from specific aims orientation to goals and deliverables on projects. Our skills development efforts emphasized commercialization and a deep understanding of customer needs for new technology adoption. Here, we review our experiences, outcomes, and insights, including the challenges identified in program implementation.

Rapid whole genome sequencing (rapid WGS) is a powerful diagnostic tool that is becoming increasingly practical for widespread clinical use. However, protocols for its use are challenging to implement. A significant obstacle to clinical adoption is that laboratory certification requires an initial research development phase, which is constrained by regulations from returning results. Regulations preventing return of results have ethical implications in cases which might impact patient outcomes. Here, we describe our experience with the development of a rapid WGS research protocol, that balanced the requirements for laboratory-validated test development with the ethical needs of clinically relevant return of results.

Clinical research coordinators are increasingly tasked with a multitude of complex study activities critical to scientific rigor and participant safety, though more than half report not receiving appropriate training. To determine the reproducibility of an established clinical research workforce orientation program, collaborative partners across Clinical and Translational Science Award institutions seeded core principles and structure from Mayo Clinic’s Clinical Research Orientation program within Penn State University and the University of Mississippi Medical Center from 2019 to 2021. Training concepts were established and tied to those domains deemed critical by the Joint Task Force for Clinical Trial Competency for the conduct of clinical research at the highest levels of safety and quality possible. Significant knowledge and confidence gains and high overall program satisfaction were reported across participants and partner sites, despite programs being required to pivot from traditional, in-person formats to entirely virtual platforms as a result of the COVID-19 pandemic. The successful standardization and translation of foundational clinical research training has important efficiency and efficacy implications for research enterprises across the USA.

Little is known about the number of minors enrolled in clinical research today. IRB administrators at leading pediatric medical centers were surveyed regarding studies with minors. Analyses were descriptive in nature with adaptive Bayesian bootstrap imputation used with missing data. Officials from 17/41 (41.5%) pediatric research centers responded: 74,204 active studies were estimated, 29,078 (39%) included minors, and 6574 (23%) were “more than minimal risk.” Minors accounted for 0.7–2.87M research subjects. Pediatric medicine desperately needs a more accurate and reliable reporting system for tracking the recruitment, retention, and involvement of minors in clinical research.

Stakeholder engagement is increasingly expected by funders and valued by researchers in clinical and translational science, yet many researchers lack access to expert consultation or training in selecting appropriate stakeholder engagement methods. We describe the development of a novel Stakeholder Engagement Navigator webtool. We conducted an environmental scan and literature review, along with investigator interviews, surveys, and engagement expert facilitated group discussion. We formally reviewed and cataloged 29 distinct engagement methods. To develop the webtool, we used an iterative design process that followed Design Thinking phases: empathize, define, ideate, prototype, and test. As prioritized during user testing, the Stakeholder Engagement Navigator webtool both educates and guides investigators in selecting an engagement method based on key criteria. The V1.0 Navigator webtool filters methods first by purpose of engagement (noted by 62% of users as the highest priority criteria), then by budget, time per stakeholder interaction, and total interactions. The tool is available at DICEMethods.org. The Stakeholder Engagement Navigator webtool is a user-centered, interactive webtool suitable for use by researchers seeking guidance on appropriate stakeholder engagement methods for clinical and translational research projects.

Leveraging elements of game design and theories of human motivation, gamification provides a variety of techniques to engage learners in novel ways. Our Clinical and Translational Science Award created the software platform (Kaizen-Education©) to deliver gamified educational content in 2012. Here, we explore two novel use cases of this platform to provide practical insights for leveraging these methods in educational settings: (1) national training in rigor, reproducibility, and transparency and (2) attainment of learner competency (n = 7) as a gauge of curricular effectiveness across Master of Public Health degree tracks (n = 5). Data were captured in real time during player interaction with Kaizen-Education© to provide descriptive analyses of player engagement in both implementation examples. We then assessed item analysis to assess knowledge gain and competency attainment. We have just begun to leverage the potential for gamification to engage learners, enhance knowledge acquisition, and document completion of training, across various learning environments. We encourage a systematic approach to gamification applying insights from self-determination theory to learners and learning environments, a methodical approach to game design and rigorous analysis after implementation to generate evidence-based insights to maximize educational return for time invested.