Background:Underrepresented communities in the Southwestern United States Borderlands region face disproportionate substance use disorder (SUD) burdens yet remain largely excluded from clinical trials. No existing resource integrates health beliefs, research literacy, and vulnerability frameworks to support diverse community engagement in SUD clinical trials. Methods:We developed the Exploring Health Beliefs for Community Engagement and Diversity in Clinical Trials (EXPLORE) Toolkit through a multi-phase process (2021-2024) including systematic review of existing toolkits, domain development, platform design, individual interviews (n = 10), and two rounds of theater testing with community health workers serving Hispanic communities in Southern New Mexico (n = 60) and American Indian communities in Northern New Mexico (n = 25). Pre/post surveys assessed feasibility, acceptability, community interest, and research literacy. Ripple Effects Mapping evaluated the development process. Results:Domain-specific toolkit importance ratings averaged 4.48-4.61 on a 5-point scale; 79% of participants rated the toolkit "very important" for promoting culturally competent research, and 64% were "very likely" to recommend it. Post-theater testing scores improved for perceived feasibility of conducting clinical research in participants' communities (pre: 7.19 vs. post: 7.94, 10-point scale) and research terminology understanding (pre: 7.97 vs. post: 8.74). Qualitative themes included cultural appropriateness, the role of community gatekeepers, and confidentiality concerns in rural and border communities. Conclusions:The EXPLORE Toolkit demonstrates promise for bridging researcher-community gaps in SUD clinical trials. Findings highlight the value of interdisciplinary, community-centered development and the need for ongoing cultural adaptation. The toolkit is freely available at https://www.exploretoolkit.org/.
The William Schnaper Visiting Scientist (WSVS) Mini-Symposium was established within the National Center for Advancing Translational Sciences (NCATS) Clinical and Translational Science Award (CTSA) consortium to provide predoctoral and postdoctoral trainees with opportunities to present research, develop communication skills, and foster cross-institutional collaboration through a fully virtual, trainee-centered format. We describe the structure, implementation, and outcomes of seven WSVS Mini-Symposia conducted from 2021 to 2025. Program metrics included participation across CTSA hubs, trainee roles, research domains represented, and survey-based evaluations from presenters and attendees assessing perceived value, professional development, and program logistics. Seven symposia featured 62 trainee presenters from 28 CTSA hubs across 21 U.S. states. Most presenters were predoctoral trainees (79%), and research spanned basic (34%), clinical (52%), and implementation/public health (13%) domains. Survey responses indicated strong perceived benefit: 100% of presenters reported value for professional development and roughly 50% reported receiving useful feedback and establishing new professional contacts; 78% of attendees reported the symposium was a valuable learning experience. The WSVS Mini-Symposium demonstrates that a scalable, trainee-led virtual forum can effectively promote scientific communication, networking, and workforce development across geographically distributed training programs. This model provides a sustainable framework for enhancing translational science training nationwide.
Background:Physical activity and team sport participation in adolescence are associated with positive health outcomes, stronger social skills, and improved mental health. However, negative health consequences are frequently associated with contact/collision sports like football. The objective of this study was to examine any change in health-related quality of life (HRQoL) and pediatric well-being among adolescent males after participating in a single season of football. Method:A cross-sectional study design was utilized in a high school football setting. Participants included Black/African American adolescent male football players (n = 83) from five schools within rural Alabama. Pediatric HRQoL and well-being measures were administered at preseason and postseason, including Life Satisfaction, Emotional Support, Psychological Stress, Physical Stress, Depressive Symptoms, Sleep Disturbance, and Peer Relationships. Based on normative data, participants' scores were classified as within normal limits (WNL) (T-score = 40-60) or clinically reduced (T-score < 40) or elevated (T-score > 60) depending on orientation of each questionnaire. Each outcome from pre-to-postseason evaluation was compared using a within-persons t-test. Results:Most participants (69.9-84.3%) had HRQoL/well-being scores WNL and scores remained unchanged at postseason evaluations. However, on average, physical (p = 0.035, d = 0.24) and psychological stress (p = 0.014, d = 0.28) showed small, but significant increases from pre-to-postseason. Conclusions:Modest increases in physical and psychological stress were found from preseason to postseason. Both football and non-football-related stressors could have contributed to this change. Other HRQoL/well-being scores generally showed no change. Though the health risks associated with contact/collision sports deserve attention, current findings suggest a season of football may not be associated with adverse changes in HRQoL/well-being.
Equitable participation in clinical research is essential to generating broadly generalizable findings and advancing public health. Yet persistent sociodemographic disparities, driven by mistrust, limited access, and inadequate community engagement, continue to exclude underrepresented racial and ethnic groups from research. To address these barriers, the University of Texas Southwestern Medical Center developed a comprehensive, multi-component community engagement model designed to build trust and enhance research readiness among UREG. The model integrates eight synergistic programs aligned across the five-level Social Ecological Model, including HealthStreet screening events, a Health Needs Assessment, the Community Research Registry, the North Texas Community Health Coalition, Community Engagement Grand Rounds, the Spanish Language Resource, the Community Advisory Panel, and a Community Health Grant Program. These initiatives collectively provide culturally informed outreach and structured pathways for bidirectional input from community members. Since 2023, the model has achieved substantial impact, including 5069 community-based health screenings, over 100 consultations to investigators, and more than $44 million in funded grants. Findings demonstrate that sustained, multi-level engagement can strengthen trust, expand research access, and support more equitable translational science.
Cervicovaginal fluid (CVF) represents a promising biospecimen for ovarian cancer biomarker discovery, but metabolomics typically requires specialized collection methods. We assessed the feasibility of applying untargeted metabolomics to self-collected CVF from 10 ovarian cancer patients in the ORCHiD (Ovarian Cancer Epidemiology, Healthcare Access and Disparities) study using ultrahigh performance liquid chromatography-tandem mass spectroscopy. We detected 1107 compounds mapping to 1002 unique metabolite identifiers across 9 super chemical classes, with detection rates of 62-99%. One-third of detected metabolites overlapped with published studies, while two-thirds were novel. Sample-level detection profiles were broadly consistent. Untargeted metabolomics on self-collected CVF is technically feasible and enables metabolite discovery for population-based cancer research.
Introduction:Gaining clinical trial design and management experience can be challenging for students in class. Opportunities for students to participate in designing and implementing a "from scratch" design are essential to succeeding after graduating. Limited materials are available that provide meaningful opportunities for learners to practice and implement adaptive trial design. As a solution, we developed an open-source case study framework that instructors can use directly in a course to give students hands-on experience with Bayesian adaptive trial design and implementation. Materials and methods:We developed an open case study (DRIVE trial) project, which offers an instructor-ready framework organized into seven components. Each component is designed to map onto a distinct stage of a clinical trial and include materials that instructors can adapt to match their course level and chosen scientific questions. These components are tied together by a worked example in which, after comparing multiple study designs, a Bayesian adaptive design with response adaptive randomization was chosen and implemented throughout the framework. Results and discussion:The framework provides instructors with a complete, ready-to-use template for bringing adaptive trial experience into the classroom without building a case study from scratch. The study's significance lies in its broader implications for biostatistics student training and experience. The trial underscored the effectiveness of comparing study designs and the necessity for collaboration when implementing a clinical trial. This offers valuable practical training and resources for future biostatisticians, serving as a template across various fields. Supplementary materials for this article can be found online (https://github.com/BayesPhase/DRIVE).
Introduction:Tailored carbohydrate-counting (CC) resources are helpful for diabetes self-management from an educator and patient perspective. Because these resources are unavailable in Malawi, we developed both pictorial paper-based and mobile app CC resources and explored clinical dietitians' perceptions of these resources after using them in routine clinical practice. Methods:The initial pictorial paper-based CC resource was developed using foods informed by a previous study and input from clinical dietitians.Nutrient composition of foods was determined from the Malawi Food Composition Table and similar sources. We collaborated with clinical dietitians and app developers through a user-centered design/user experience approach, an iterative process to develop the mobile app CC. Five clinical dietitians then integrated both the pictorial paper-based and mobile app CC resources into routine clinical care for patients with diabetes, both inpatient and outpatient, for 10 working days. Subsequently, we conducted in-depth interviews to elicit their perceptions and analyzed the data using thematic analysis. Results:Pictures of portioned foods were displayed alongside standardized utensils, food names in English and Chichewa, net weight, carbohydrate content, and the number of carbohydrate counts. The mobile app featured the following tabs: patient profile, carbohydrate information, food comparison, carbohydrate count, and meal planning. Four themes emerged from the in-depth interviews: ease and feasibility of use; benefits to dietetic practice; challenges with using the pictorial paper-based and mobile app; and perceived areas requiring improvement. Conclusions:The pictorial paper-based and mobile app CC resources were deemed easy to use and feasible for routine diabetes counseling, hence useful in low-resource settings.
Translational Workforce Development (TWD) is critical for Clinical and Translational Science Award (CTSA) hubs preparing Clinical Research Professionals (CRPs) to conduct high-quality research. Yet programs struggle to reflect the practical demands of CRP roles, and generalized training often leads to disengagement and limited transfer of learning into practice. Using dissemination science principles, we applied findings from a single-site CRP needs assessment and the Research Knowledge Transfer Utilization (RKTU) framework to inform a redesigned approach to TWD. Survey data (n = 65) were analyzed to identify training needs, contextual factors, preferred formats, motivators, and knowledge broker and champion roles in supporting engagement and sustained knowledge use. CRPs described inconsistent onboarding, limited structured support, and challenges aligning existing training with real-world workflows. Respondents expressed interest in practice-based, role-aligned learning delivered through blended formats such as on-demand modules, hybrid workshops, and hands-on simulation. Motivators included career pathways, community connection, and protected time, while workload and system complexity were key barriers. Despite these challenges, CRPs demonstrated readiness to learn when supported by clear expectations and accessible resources. The resulting model provides administrators with a scalable, context-informed approach for co-creating TWD programs embedded within organizational systems and aligned with the realities of clinical research practice.
Older adults experience high rates of chronic disease that reduce quality of life and independence. In South Texas, these challenges are compounded by limited access to culturally aligned care and a high burden of chronic conditions. Addressing these disparities requires infrastructure that bridges research and practice to support the translation of evidence into real-world care. This manuscript describes the establishment of the Supporting Older Adults through Research Network (SOARNet), a population-specific practice-based research network (PBRN) and reports early lessons from its development and recruitment strategies. SOARNet employs a multi-level leadership structure and an Advisory Board to guide research priorities, review member-initiated proposals, and facilitate collaboration among clinical, research, and community stakeholders. Recruitment strategies included informational materials, clinic visits, and targeted email outreach. Since inception, SOARNet has enrolled 61 members representing healthcare clinicians (55.7%), researchers (18.0%), community members (32.8%), and organizations (8.2%), with targeted email outreach proving most effective (n = 56). SOARNet has supported a collaborative research study, facilitated member consultations, and contributed to dissemination activities. These findings demonstrate the value of population-specific PBRNs in advancing community-engaged translational research to improve care for older adults. Future priorities focus on expanding partnerships and strengthening culturally responsive, bidirectional research.
Clinical and translational investigators increasingly rely on complex institutional and national data resources, yet barriers related to data discovery, governance, and access pathways remain common. To address fragmentation in data access, we piloted a Data Navigation Program within the Clinical and Translational Science Institute (CTSI) that established a trained Data Navigator as a centralized first point of contact for investigator data inquiries who provided individualized consultations, facilitated connections to data domain experts and honest broker services, and increased awareness of institutional data assets and regulatory requirements. To better characterize investigator needs, a CTSI-wide survey assessing data sources, governance, and training priorities was conducted in collaboration with the Clinical Translational Data Science (CTDS) Workgroup. Results demonstrated strong demand for structured guidance in data discovery and governance navigation. These findings informed refinement of the program, including development of the Research Data Source Match, a self-service decision-support tool implemented in REDCap that generates customized data access roadmaps based on investigator characteristics and data needs. During the pilot year, the Data Navigator conducted consultations addressing electronic health record (EHR), PCORnet resources, and government datasets. Integrating personalized navigation with scalable self-service tools may reduce barriers and support responsible data use in translational research.
Community engagement is essential to research. Community Advisory Boards (CABs) are frequently consulted to inform recruitment and engagement strategies. In our experience, a gap emerged between CAB recommendations and implementation, largely due to limitations in research infrastructure, funding, and team capacity. Researchers may underappreciate why providing contextual details about studies that relate to resources or constraints, can lead to tailored recommendations. In response, our institutional CAB now incorporates researcher input before and after consultations to clarify programmatic and institutional limitations. This ongoing, bidirectional dialogue supports more pragmatic, tailored recommendations that better align with research team capacity while advancing shared goals.
Social media offers research teams new opportunities for outreach and study recruitment; however, research teams often need guidance and tools on how to use social media to effectively recruit for their clinical trials. To address this gap, the Recruitment Innovation Center (RIC) developed a new, comprehensive toolkit informed by community feedback and extensive RIC experience. The toolkit contains guidance and considerations for using social media to recruit clinical trial participants, including best practices, platform-specific strategies, and customizable templates. This paper details the creation and contents of this new, free resource.
The pediatric urgent care setting offers a unique opportunity to enroll pediatric patients and their families to facilitate the study of human immunology. However, it is an underutilized environment for recruiting participants into research studies, most likely driven by a fundamental "conflict of urgency" - the tension between the time-limited nature of acute ambulatory care and the time-intensive requirements of human subjects research. To address this challenge, we implemented a study of infant and maternal immune responses to respiratory tract infection (the MATMilk study) across four Seattle Children's Hospital Urgent Care (SCHUC) clinics using a novel, two-phase study design, which uncoupled initial clinical contact from enrollment and specimen collection. This approach allowed complete remote participation and minimized disruption to clinical workflows. To date, we have enrolled n = 36 infants and n = 39 mothers and have complete biospecimen sets from n = 30 infants and n = 28 mothers. The cohort is from a broad geographical catchment in the Puget Sound region and is racially and ethnically diverse, reflecting the demographics of the SCHUC patient population. Our scalable, resource-efficient approach provides a model for integrating basic science research into hospital-affiliated pediatric urgent care networks.
Background:Translational science (TS) workforce development initiatives are emerging to fast-track conversion of findings into applications to improve health. Principles of TS were developed to guide workforce development; however, few tools are available to evaluate confidence related to these principles to benchmark progress. Objective:Our goal was to develop and validate a scale for assessing confidence related to the seven TS principles and get feedback about future workforce development opportunities that could be evaluated with this scale. Methods:A cross-sectional survey was conducted in 2025 engaging 158 researchers and research staff affiliated with three Clinical and Translational Science Award hubs in Alabama, Massachusetts, and Ohio. Factor analysis was conducted to determine interrelatedness among the TS principles, reliability was assessed using Cronbach's alpha, and mixed effects models were used to examine differences in confidence levels. Results:Four factors emerged (α = 0.95 for full scale, 14 items), including Taking Risks for Impact (α = 0.85, 2 items), Multi-perspective Research (α = 0.88, 3 items), Collaborative Methods (α = 0.89, 6 items), and Efficiency and Productive Failure (α = 0.88, 3 items). Confidence levels varied significantly by factor (p < 0.001) with the lowest mean confidence (1 = lowest, 5 = highest) for the Efficiency and Productive Failure (2.56) and Taking Risks for Impact (2.79) factors. There were no differences in mean levels of confidence by demographics, site, or experience. Conclusion:Findings provide guidance for prioritizing topics for future TS workforce development initiatives as well as a brief scale for evaluating how these interventions cultivate confidence across the seven TS principles.
Introduction: Research participants express strong desires to receive their individual research results (IRR), consistent with key ethical principles of research. Participants' preferences, especially when based on past experiences with IRR, can help in formulating approaches to the process.Methods: Participants (n = 149) were recruited from a site of the eMERGE-IV study, which returned risk estimates for 8 common diseases based on polygenic scores and other factors. Most were White, highly educated, and English-speaking. Participants completed an online survey regarding their eMERGE experiences, the impact of IRR on future research participation, and their preferences for returning results.Results: Respondents indicated that receiving results would be very important in their decisions about future studies; 64.9% gave it the highest importance rating. They wanted IRR to improve their own and their families' health. Concerns about risks were low. Most said they were likely to share the information with other people. Respondents preferred receiving results from health professionals associated with the study, as opposed to their own physicians. They favored return by email and videoconferencing, as opposed to in-person visits or mail. Respondents desired information in various formats to help them understand and act on the results.Conclusions: These results underscore the importance that research participants place on IRR and provide guidance on the best ways to provide them. A strength of these findings is that they reflect the experiences of respondents who already received IRR. Investigators should consider how best to offer IRR to their participants; funders should provide appropriate support for the process.
Introduction:Multicenter clinical trials have become increasingly larger and more complex yet assuring high-quality data remains an essential task for data coordinating centers. Methods:A flexible algorithm is presented to exhaustively search for potential data anomalies by participant and site. The algorithm proceeds as a three-phase collaboration between the data coordinating center and clinical sites. First, participant-level data are examined in a univariate approach for all relevant variables. Values at the extreme tails of the distribution that also lie outside range checks and are previously unverified by clinical sites are deemed potential outliers. Second, participant-level data are examined in a multivariate machine learning approach among meaningful groups of related variables, e.g., weight and body mass index. Third, site-level differences are characterized using statistical tests and standardized differences, both adjusted and unadjusted for site demographics. Findings are discussed with sites and, if needed, alterations can be made to procedures for data collection. For illustration, the algorithm is applied to data collected in the Molecular Transducers of Physical Activity Consortium (MoTrPAC) study. Results:Application of the algorithm to MoTrPAC yielded an evaluation of over 1.9 million observations in n = 1029 study participants. Numerous individual univariate, multivariate, and site-level outliers were identified that were previously unidentified by existing data evaluation processes. Conclusion:It is recommended to apply this algorithm to a subset of participants early in a study, with repeated explorations over subsequent intervals throughout the study. The goal is to maximize data quality, particularly critical to the increasing occurrence of open-source, data resources.
The goal of this study was a re-analysis of a randomized controlled trial evaluating the effectiveness of Attachment and Biobehavioral Catchup (ABC), an early childhood parenting intervention. We compared the effectiveness of ABC for enhancing parental sensitivity and child behavior among 79 dyads who received the intervention as delivered by peer support specialists (n = 49 dyads) or master's-level clinicians (n = 30 dyads). Peer support parent coaches were non-inferior at enhancing parental sensitivity and parental intrusiveness as parent coaches with a master's degree. This research has important clinical implications for increasing access to ABC for parents involved in the child welfare system.
Diabetes mellitus is a significant health burden, and recent reports indicate an increase in diabetes-related complications in the United States (U.S.). The mission of the National Institute of Diabetes and Digestive and Kidney Diseases Centers for Diabetes Translational Research (CDTR) is to improve the translation of research findings in diabetes prevention and treatment by supporting research across the translational science spectrum. To facilitate this mission, it is imperative to support multidisciplinary translational early-stage investigators (ESIs) to address the societal-, environmental-, and individual-level factors that impact diabetes outcomes. In this special communication article, we characterize the challenges, opportunities, and needs of ESIs transitioning to mid-careers whose goals are to develop a career in diabetes translational research. These challenges and opportunities were collected from 34 ESIs and 19 senior faculty members from 23 institutions across the U.S. who attended the inaugural CDTR National Enrichment Program Conference. Our findings aim to promote the engagement of ESIs in diabetes translational research and provide guidance in strengthening and sustaining their research careers.
Background: In the COVID-19 pandemic, several phase II and III randomized trials were launched to evaluate the effectiveness of camostat, an orally administered TMPRSS2 inhibitor previously approved for other indications, for treating SARS-CoV-2 infections. Owing to the rapidly changing landscape during the pandemic, many of these trials were unable to reach completion. Further, methods for synthesizing trials that were launched and not completed were critical.Methods: This systematic review aimed to consolidate global evidence by identifying placebo controlled, randomized trials of camostat and analyzing their collective clinical and virologic impact on SARS-CoV-2 through an individual patient data meta-analysis (IPDMA). We harmonized data from the studies and utilized Bayesian statistical models to assess virologic outcomes (measured by the rate of change in viral shedding) and clinical outcomes (based on the time to the first of two consecutive symptom-free days), adjusting for age and sex.Results: The IPDMA incorporated data from six countries, totaling 431 patients across the studies; 118 patients contributed data for the primary virologic outcome and 240 for the clinical symptom outcome. Camostat did not improve the rate of change in viral load (difference in rate of change = 0.11 Ct value/day higher, 95% credible interval 2.04 lower to 2.23 higher) or time to symptom resolution (hazard ratio = 0.87, 95% credible interval 0.51, 1.55) when compared to placebo.Conclusions: Despite its theoretically promising mode of action, camostat did not demonstrate a statistically significant virologic or clinical benefit in treating COVID-19, highlighting the complexity of drug repurposing in emergency health situations.
