The National Clinical and Translational Science Award (CTSA) Consortium 2.0 has developed common metrics as a collaborative project for all participating sites. Metrics address several important aspects and functions of the consortium, including workforce development. The first workforce development metrics to be proposed for all CTSA hubs include the proportion of CTSA-supported trainees and scholars with sustainable careers in translational research and the diversity and inclusiveness of programs.

The University of Utah Center for Clinical and Translational Science (CCTS), a CTSA hub, has been actively engaged in mentoring translational scientists for the last decade. We have developed programs, processes, and institutional policies that support translational scientists, which have resulted in 100% of our KL2 scholars remaining engaged in translational science and in increasing the inclusion of individuals under-represented in medicine in our research enterprise. In this paper, we share details of our program and what we believe are evidence-based best practices for developing sustainable translational research careers for all aspiring junior faculty members.

The University of Utah Center for Clinical and Translational Science has been integral in catalyzing interactions across the campus to reverse the negative trends seen nationally in sustaining clinician scientists. Our programs and processes can serve as a model for other institutions seeking to develop translational scientists.

The Institute of Translational Health Sciences (ITHS) promotes and supports translational research collaboration between clinicians, communities, and investigators across the five-state Washington, Wyoming, Alaska, Montana, and Idaho (WWAMI) region. The ITHS has developed a collaborative regional clinical research network, the Northwest Participant & Clinical Interactions Network (NW PCI), involving 12 diverse clinical health systems and academic institutions.

This descriptive article details NW PCI’s development, infrastructure and governance, tools, characteristics, and initial outcomes.

Regional NW PCI sites are conducting largely industry-sponsored studies; they are interested in including more grant-funded research. Regional NW PCI sites had over 1,240 open studies involving over 6700 patients in 2016. NW PCI trials are largely industry-sponsored; NW PCI sites are interested in including more grant-funded research. In its first three years, the NW PCI Coordinating Center facilitated regional sites’ participation in 34 new grant and contract applications across diverse topics.

The NW PCI model supports the goals of the developing CTSA Trial Innovation Network by increasing access to cutting-edge research across the Northwestern U.S., by supporting investigators seeking diverse populations, including those with rare diseases, for their research studies, and by providing settings to test implementation and dissemination of effective interventions.

Space matters. We read space like we read people’s faces. Space is an instrument of collaboration and innovation. At the University of Michigan’s Institute for Clinical and Health Research (MICHR), a team was created to creatively and economically enhance our operating space into a flexible workspace that supports privacy, innovation, creativity, and most important, a culture of collaboration.

The team used a human-centered design process to creatively engage the staff at large into analyzing our existing space, identifying latent needs, proposing solutions, generating feedback, and economically building the rethought process.

The redesigned workspace embraces the differences among MICHR’s teams while encouraging collaboration and teamwork and keeping costs at a minimum. It has resulted in a flexible space that includes co-located teams, spaces dedicated to different work goals, an open area for collaboration, quiet zones for focused work, and better wayfinding.

Through our Rethink Space project, we hope to have demonstrated that, by initiating the project internally and by engaging the users of the space themselves in an empathetic, visual, and human-centered way, a space redesign can be undertaken economically while also leading to improved levels of employee and team satisfaction.

There is a dearth of literature providing guidance on how to effectively communicate about clinical research (CR).

Using the transactional model of communication, a content analysis of the investigator (n=62) and participant (n=18) Web sites of institutions funded through the National Institutes of Health Clinical and Translational Science Award (CTSA) was conducted to identify their strategies (e.g., messages) for communicating about CR participation.

CTSAs targeted investigators with CR participation content across the main Web sites, although most CTSAs (n=55; 88.7%) also included CR participation content for participants. In total, 18 CTSAs (29%) hosted participant Web sites. Participant sites included 13 message types about CR participation (e.g., registry enrollment) and 5 additional channels (e.g., email, phone number) to communicate about CR. However, many CTSA participant Web sites excluded information explaining the CR process and offered CR content exclusively in English.

CTSAs should identify their target audience and design strategies (e.g., messages, channels) accordingly.

The Institute of Translational Health Sciences (ITHS), a Clinical and Translational Science Award (CTSA)-funded program at the University of Washington (UW), established the Drug and Device Advisory Committee (DDAC) to provide product-specific scientific and regulatory mentoring to investigators seeking to translate their discoveries into medical products. An 8-year retrospective analysis was undertaken to evaluate the impact of the DDAC programs on commercialization metrics.

Tracked metrics included the number of teams who consulted with the DDAC, initiated a clinical trial, formed a startup, or were successful obtaining federal small business innovation awards or venture capital. The review includes historical comparisons of the startup rates for the UW School of Medicine and the Fred Hutchinson Cancer Research Center, two ITHS-affiliated institutions that have had different DDAC utilization rates.

Between 2008 and 2016, the DDAC supported 161 unique project teams, 28% of which went on to form a startup. The commercialization rates for the UW School of Medicine increased significantly following integration of the DDAC into the commercialization programs offered by the UW technology transfer office.

A formalized partnership between preclinical consulting and the technology transfer programs provides an efficient use of limited development funds and a more in-depth vetting of the business opportunity and regulatory path to development.

The Rockefeller Clinical Scholars (KL2) program began in 1976 and transitioned into a 3-year Master’s degree program in 2006 when Rockefeller joined the National Institute of Health Clinical and Translational Science Award program. The program consists of ∼15 trainees supported by the Clinical and Translational Science Award KL2 award and University funds. It is designed to provide an optimal environment for junior translational investigators to develop team science and leadership skills by designing and performing a human subjects protocol under the supervision of a distinguished senior investigator mentor and a team of content expert educators. This is complemented by a tutorial focused on important translational skills.

Since 2006, 40 Clinical Scholars have graduated from the programs and gone on to careers in academia (72%), government service (5%), industry (15%), and private medical practice (3%); 2 (5%) remain in training programs; 39/40 remain in translational research careers with 23 National Institute of Health awards totaling $23 million, foundation and philanthropic support of $20.3 million, and foreign government and foundation support of $6 million. They have made wide ranging scientific discoveries and have endeavored to translate those discoveries into improved human health.

The Rockefeller Clinical Scholars (KL2) program provides one model for translational science training.

Research organizations face challenges in creating infrastructures that cultivates and sustains interdisciplinary team science. The objective of this paper is to identify structural elements of organizations and training that promote team science.

We qualitatively analyzed the National Institutes of Health’s Building Interdisciplinary Research Careers in Women’s Health, K12 using organizational psychology and team science theories to identify organizational design factors for successful team science and training.

Seven key design elements support team science: (1) semiformal meta-organizational structure, (2) shared context and goals, (3) formal evaluation processes, (4) meetings to promote communication, (5) role clarity in mentoring, (6) building interpersonal competencies among faculty and trainees, and (7) designing promotion and tenure and other organizational processes to support interdisciplinary team science.

This application of theory to a long-standing and successful program provides important foundational elements for programs and institutions to consider in promoting team science.

This study uses KL2 scholars’ publications to evaluate the types of research the KL2 program supports and to assess the initial productivity and impact of its scholars.

We illustrate the feasibility of 3 different approaches to bibliometrics, one viable method for determining the types of research a program or hub supports, and demonstrate how these data can be further combined with internal data records.

Gender differences were observed in the types of research scholars undertake. Overall KL2 scholars are performing well, with their publications being cited more than the norm for National Institutes of Health publications. Favorable results were also observed in scholars’ continued engagement in research.

This study illustrates that linking bibliometric data and data categorizing publications along the translational spectrum with a Clinical and Translational Science Award hub’s internal data records is feasible and offers a number of innovative possibilities for the evaluation of a Clinical and Translational Science Award hub’s programs and investigators.

The translation of discoveries to drugs, devices, and behavioral interventions requires well-prepared study teams. Execution of clinical trials remains suboptimal due to varied quality in design, execution, analysis, and reporting. A critical impediment is inconsistent, or even absent, competency-based training for clinical trial personnel.

In 2014, the National Center for Advancing Translational Science (NCATS) funded the project, Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ), aimed at addressing this deficit. The goal was to ensure all personnel are competent to execute clinical trials. A phased structure was utilized.

This paper focuses on training recommendations in Good Clinical Practice (GCP). Leveraging input from all Clinical and Translational Science Award hubs, the following was recommended to NCATS: all investigators and study coordinators executing a clinical trial should understand GCP principles and undergo training every 3 years, with the training method meeting the minimum criteria identified by the International Conference on Harmonisation GCP.

We anticipate that industry sponsors will acknowledge such training, eliminating redundant training requests. We proposed metrics to be tracked that required further study. A separate task force was composed to define recommendations for metrics to be reported to NCATS.

The Resource Centers for Minority Aging Research (RCMAR) program was launched in 1997. Its goal is to build infrastructure to improve the well-being of older racial/ethnic minorities by identifying mechanisms to reduce health disparities.

Its primary objectives are to mentor faculty in research addressing the health of minority elders and to enhance the diversity of the workforce that conducts elder health research by prioritizing the mentorship of underrepresented diverse scholars.

Through 2015, 12 centers received RCMAR awards and provided pilot research funding and mentorship to 361 scholars, 70% of whom were from underrepresented racial/ethnic groups. A large majority (85%) of RCMAR scholars from longstanding centers continue in academic research. Another 5% address aging and other health disparities through nonacademic research and leadership roles in public health agencies.

Longitudinal, team-based mentoring, cross-center scholar engagement, and community involvement in scholar development are important contributors to RCMAR’s success.

UMHealthResearch is the University of Michigan’s digital health research recruitment platform. It allows health researchers to connect efficiently with potentially eligible volunteers.

In 2013, the UMHealthResearch team strategically adapted a consumer behavior model, the buying funnel, to create the Digital Health Research Participation Funnel. The Digital Health Research Participation Funnel was then used to design a more active way for potential participants to volunteer for research studies through UMHealthResearch.

In the 5 years before the redesign (2007–2012), an average of 1844 new accounts were created every year, whereas in the completed years after the redesign (2013–2016) the annual average improved to 3906, an increase of 111%.

Although a randomized design was not possible in this instance, these preintervention and postintervention data suggest that the focus on user experience is an effective strategy for improving web-based research recruitment platforms.

The glucocorticoid receptor (GR) is a key receptor involved in inflammatory responses and is influenced by sex steroids. This study measured GR expression on circulating leukocyte subtypes in males and females.

A total of 23 healthy adults (12 female) participated in this study. GR expression was measured in leukocyte subtypes using flow cytometry. Peripheral blood mononuclear cell (PBMC) gene expression of GR (NR3C1), GR β, TGF-β1 and 2, and glucocorticoid-induced leucine zipper (GILZ) were determined by real-time polymerase chain reaction.

Leukocyte GR was lower in females, particularly in granulocytes, natural killer cells, and peripheral blood mononuclear cells (p≤0.01). GR protein expression was different across leukocyte subtypes, with higher expression in eosinophils compared with granulocytes, T lymphocytes, and natural killer cells (p<0.05). There was higher gene expression of GR β in males (p=0.03).

This is the first study to identify sexual dimorphism in GR expression in healthy adults using flow cytometry. These results may begin to explain the sexual dimorphism seen in many diseases and sex differences in glucocorticoid responsiveness.

The final rule for the protection of human subjects requires that informed consent be “in language understandable to the subject” and mandates that “the informed consent must be organized in such a way that facilitates comprehension.” This study assessed the readability of Institutional Review Board-approved informed consent forms at our institution, implemented an intervention to improve the readability of consent forms, and measured the first year impact of the intervention.

Readability assessment was conducted on a sample of 217 Institutional Review Board-approved informed consents from 2013 to 2015. A plain language informed consent template was developed and implemented and readability was assessed again after 1 year.

The mean readability of the baseline sample was 10th grade. The mean readability of the post-intervention sample (n=82) was seventh grade.

Providing investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.

Clinical research involving humans is critically important, but it is a lengthy and expensive process. Most studies require institutional review board (IRB) approval. Our objective is to identify predictors of delays or accelerations in the IRB review process and apply this knowledge to inform process change in an effort to improve IRB efficiency, transparency, consistency and communication.

We analyzed timelines of protocol submissions to determine protocol or IRB characteristics associated with different processing times. Our evaluation included single variable analysis to identify significant predictors of IRB processing time and machine learning methods to predict processing times through the IRB review system. Based on initial identified predictors, changes to IRB workflow and staffing procedures were instituted and we repeated our analysis.

Our analysis identified several predictors of delays in the IRB review process including type of IRB review to be conducted, whether a protocol falls under Veteran’s Administration purview and specific staff in charge of a protocol's review.

We have identified several predictors of delays in IRB protocol review processing times using statistical and machine learning methods. Application of this knowledge to process improvement efforts in two IRBs has led to increased efficiency in protocol review. The workflow and system enhancements that are being made support our four-part goal of improving IRB efficiency, consistency, transparency, and communication.