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.

A Health Equity Task Force (HETF) of members from seven Centers funded by the National Cancer Institute’s (NCI) Implementation Science in Cancer Control Centers (ISC3) network sought to identify case examples of how Centers were applying a focus on health equity in implementation science to inform future research and capacity-building efforts.

HETF members at each ISC3 collected information on how health equity was conceptualized, operationalized, and addressed in initial research and capacity-building efforts across the seven ISC3 Centers funded in 2019–2020. Each Center completed a questionnaire assessing five health equity domains central to implementation science (e.g., community engagement; implementation science theories, models, and frameworks (TMFs); and engaging underrepresented scholars). Data generated illustrative examples from these five domains.

Centers reported a range of approaches focusing on health equity in implementation research and capacity-building efforts, including (1) engaging diverse community partners/settings in making decisions about research priorities and projects; (2) applying health equity within a single TMF applied across projects or various TMFs used in specific projects; (3) evaluating health equity in operationalizing and measuring health and implementation outcomes; (4) building capacity for health equity-focused implementation science among trainees, early career scholars, and partnering organizations; and (5) leveraging varying levels of institutional resources and efforts to engage, include, and support underrepresented scholars.

Examples of approaches to integrating health equity across the ISC3 network can inform other investigators and centers’ efforts to build capacity and infrastructure to support growth and expansion of health equity-focused implementation science.

Effective patient engagement is central to patient-centered outcomes research. A well-designed infrastructure supports and facilitates patient engagement, enabling study development and implementation. We sought to understand infrastructure needs from recipients of Patient-Centered Outcomes Research Institute (PCORI) pilot grant awards.

We surveyed recipients of PCORI pilot project awards on self-perceived strengths in engagement infrastructure through PCORI’s Ways of Engaging-Engagement Activity Tool survey, and interviewed leaders of 8 projects who volunteered as exemplars. Descriptive statistics summarized the survey findings. We conducted a thematic analysis of the interview transcripts.

Of the 50 surveyed pilots, 22 answered the engagement infrastructure questions (44% response rate). Survey and interview findings emphasized the importance of committed institutional leadership, ongoing relationships with stakeholder organizations, and infrastructure funding through Clinical and Translational Science Awards, PCORI, and institutional discretionary funds.

These findings highlight the importance of and how to improve upon existing institutional infrastructure.

The role of lay health workers in data collection for clinical and translational research studies is not well described. We explored lay health workers as data collectors in clinical and translational research studies. We also present several methods for examining their work, i.e., qualitative interviews, fidelity checklists, and rates of unusable/missing data.

We conducted 2 randomized, controlled trials that employed lay health research personnel (LHR) who were employed by community-based organizations. In one study, n = 3 Latina LHRs worked with n = 107 Latino diabetic participants. In another study, n = 6 LHR worked with n = 188 Cambodian American refugees with depression. We investigated proficiency in biological, behavioral, and psychosocial home-based data collection conducted by LHR. We also conducted in-depth interviews with lay LHR to explore their experience in this research role. Finally, we described the training, supervision, and collaboration for LHR to be successful in their research role.

Independent observers reported a very high degree of fidelity to technical data collection protocols (>95%) and low rates of missing/unusable data (1.5%–11%). Qualitative results show that trust, training, communication, and supervision are key and that LHR report feeling empowered by their role. LHR training included various content areas over several weeks with special attention to LHR and participant safety. Training and supervision from both the academic researchers and the staff at the community-based organizations were necessary and had to be well-coordinated.

Carefully selected, trained, and supervised LHRs can collect sophisticated data for community-based clinical and translational research.

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.

Digital tools offer promising solutions to improve eligibility screening, recruitment, and retention in research, particularly in human genetic studies where representative sampling is critical. SMS text messaging has been found effective in population-based survey research, but evidence of its impact on genetic study recruitment – and how it varies by demographics – is limited.

We examined the effect of tailored SMS messages on enrollment in a population-based genomic screening study. We assessed differences in message open and consent rates across four message types and explored how these outcomes varied by demographic factors.

Participants were randomized to receive one of four SMS messages emphasizing different social values: generic, individual impact, community impact, or research discoveries. We calculated descriptive statistics for open and consent rates and used generalized linear logistic regression and Pearson’s Chi-Square Test to assess demographic differences.

Among 15,977 messages sent, 2.4% were opened (n = 382), and 35.3% of those who opened consented (n = 135). Females were more likely than males to open (3.1% vs. 1.6%) and consent (1.1% vs. 0.5%). Individuals aged 30–39 had the highest open rate (3.4%), and those 40–49 had the highest consent rate (1.6%). Message type was not significantly associated with open or consent rates.

Sociodemographic factors were more predictive of engagement than message content. Tailoring messages by demographic group may improve recruitment in genomic studies. Future research should explore the drivers of participant engagement in digital recruitment strategies.

Health systems have many incentives to screen patients for health-related social needs (HRSNs) due to growing evidence that social determinants of health impact outcomes and a new regulatory context that requires health equity measures. This study describes the experience of one large urban health system in scaling HRSN screening by implementing improvement strategies over five years, from 2018 to 2023.

In 2018, the health system adapted a 10-item HRSN screening tool from a widely used, validated instrument. Implementation strategies aimed to foster screening were retrospectively reviewed and categorized according to the Expert Recommendations for Implementing Change (ERIC) study. Statistical process control methods were utilized to determine whether implementation strategies contributed to improvements in HRSN screening activities.

There were 280,757 HRSN screens administered across 311 clinical teams in the health system between April 2018 and March 2023. Implementation strategies linked to increased screening included integrating screening within an online patient portal (ERIC strategy: involve patients/consumers and family members), expansion to discrete clinical teams (ERIC strategy: change service sites), providing data feedback loops (ERIC strategy: facilitate relay of clinical data to providers), and deploying Community Health Workers to address HRSNs (ERIC strategy: create new clinical teams).

Implementation strategies designed to promote efficiency, foster universal screening, link patients to resources, and provide clinical teams with an easy-to-integrate tool appear to have the greatest impact on HRSN screening uptake. Sustained increases in screening demonstrate the cumulative effects of implementation strategies and the health system’s commitment toward universal screening.

Decentralized clinical trials (DCTs) are often hindered by challenges in remotely capturing biomarkers. To address this gap, we developed MyTrials, a mobile application integrated with REDCap, designed to facilitate the remote capture of biomarkers via Bluetooth-enabled remote patient monitoring (RPM) devices. The purpose of the present study was to evaluate the feasibility and acceptability of MyTrials among participants within a DCT design.

In this four-arm randomized trial, 47 participants were allocated to receive zero, one, two, or three RPM devices. Participants were asked to use their devices once per week for a total of four weeks to remotely provide biomarkers via MyTrials. Feasibility was assessed using objective metrics of successful biomarker submission (i.e., valid device data accompanied by a video confirming participant identity) alongside the participant-reported Feasibility of Intervention Measure (FIM). Acceptability was evaluated via the Acceptability of Intervention Measure (AIM) and the System Usability Scale (SUS).

Among participants assigned at least one device, the successful biomarker submission rate was 74% across all study weeks. FIM and AIM scores exceeded prespecified feasibility benchmarks across all conditions except the zero-device condition. SUS scores consistently indicated high usability across all conditions (range: 77.29–94.29).

The MyTrials platform is a feasible and acceptable solution for remote biomarker capture in DCTs. These findings support the potential of MyTrials to advance remote data collection in clinical research.

Increasing interest in real-world evidence has fueled the development of study designs incorporating real-world data (RWD). Using the Causal Roadmap, we specify three designs to evaluate the difference in risk of major adverse cardiovascular events (MACE) with oral semaglutide versus standard-of-care: (1) the actual sequence of non-inferiority and superiority randomized controlled trials (RCTs), (2) a single RCT, and (3) a hybrid randomized-external data study.

The hybrid design considers integration of the PIONEER 6 RCT with RWD controls using the experiment-selector cross-validated targeted maximum likelihood estimator. We evaluate 95% confidence interval coverage, power, and average patient time during which participants would be precluded from receiving a glucagon-like peptide-1 receptor agonist (GLP1-RA) for each design using simulations. Finally, we estimate the effect of oral semaglutide on MACE for the hybrid PIONEER 6-RWD analysis.

In simulations, Designs 1 and 2 performed similarly. The tradeoff between decreased coverage and patient time without the possibility of a GLP1-RA for Designs 1 and 3 depended on the simulated bias. In real data analysis using Design 3, external controls were integrated in 84% of cross-validation folds, resulting in an estimated risk difference of –1.53%-points (95% CI –2.75%-points to –0.30%-points).

The Causal Roadmap helps investigators to minimize potential bias in studies using RWD and to quantify tradeoffs between study designs. The simulation results help to interpret the level of evidence provided by the real data analysis in support of the superiority of oral semaglutide versus standard-of-care for cardiovascular risk reduction.

IMARA-South Africa (SA) is an HIV/STI prevention program for adolescent girls and young women (AGYW) and their female caregivers (FC). We examined six implementation outcomes of IMARA-SA (acceptability, appropriateness, feasibility, reach, adoption, and sustainability) from the perspectives of study staff, investigators, and collaborators.

We used a sequential explanatory mixed-methods design. We administered surveys, hosted three focus group discussions with study staff/facilitators (n = 5), clinic staff (n = 3), and community advisory board members (n = 5), and conducted seven key informant interviews with investigators and study staff. We used descriptive statistics and rapid qualitative analyses, merging quantitative and qualitative data by implementation outcome to achieve triangulation.

On 27 surveys analyzed, mean scores were highest for acceptability (2.8/3, SD = 0.6), appropriateness (2.7/3, SD = 0.5), and reach (2.7/3, SD = 0.5), followed by feasibility (2.1/3, SD = 0.5), adoption (3.8/5, SD = 0.3), and sustainability (5.9/7, SD = 0.8). All perceived the AGYW and FC to love the program, which fit well with South African culture and addressed AGYW’s needs. The delivery site was deemed highly appropriate for reaching vulnerable populations. The lowest scoring items concerned time constraints (2.2/3, SD = 0.9), safety concerns (1.4/3, SD = 0.7), complexity (2.9/5, SD = 1.3), and cost (2.8/5, SD = 0.9). Qualitative participants attributed complexity and cost challenges to the research procedures, not the intervention. Participants proposed potential avenues for future implementation (e.g., schools, clinics) and interest in engaging males.

IMARA-SA is implementable. Findings reveal challenges with navigating trade-offs between implementation outcomes and surveys distinguishing between intervention and research activities. Findings can inform future delivery of IMARA-SA and similar programs regionally.