Journal of Clinical and Translational Science最新文献

{"title":"SPIE: An organizational framework to facilitate accessibility in academic statistical consulting centers.","authors":"Marianne Huebner, Michael Wallace, Felesia Stukes, Sam Manski, Maria Montez-Rath","doi":"10.1017/cts.2026.10712","DOIUrl":"10.1017/cts.2026.10712","url":null,"abstract":"<p><p>Academic statistical consulting centers collaborate and provide statistical support to faculty and graduate students for their research projects. Clients seeking statistical support may face communication and cognitive accessibility barriers that consultants may not be aware of. Many researchers do not disclose their personal circumstances, such as neurodivergent behaviors. Universal Design for Learning is a framework that aims to support individuals regardless of their abilities or learning styles, by providing multiple means of engagement, presentation, and action and expression. Adapting these principles for statistical consulting and taking time to assess specific needs of individuals helps improve the experiences of clients and consultants and leads to high quality statistical support and successful completion of research projects. We propose an organizational framework applicable to statistical consulting environments aligned with accessibility guidelines to improve access and empower clients and consultants. Providing a respectful environment where differences are normalized and welcomed creates a sense of belonging for everyone.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e45"},"PeriodicalIF":2.7,"publicationDate":"2026-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12975617/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147443981","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Developing the future clinical research workforce: An immersive high school clinical research summer camp.","authors":"Jessica M Fritter, Tywan Banks, Myeshia Harmon, Smitha Sasindran, Sacha Tadros, Drew E Spacht, Karen K Carter, Kelly Fannin, Lauren Jones, Carolynn Thomas Jones","doi":"10.1017/cts.2026.10707","DOIUrl":"10.1017/cts.2026.10707","url":null,"abstract":"<p><strong>Introduction: </strong>Clinical translational research relies on clinical research professional staff, and efforts to stimulate a future workforce has included outreach to high schools.</p><p><strong>Methods: </strong>We assembled a multidisciplinary team from three institutions, leveraging expertise in education, clinical translational science, and team science to design and implement a summer camp for high school students to expose them to career opportunities in clinical research. Using backward design, we developed structured lesson plans and logistical operations. Recruitment targeted rising sophomores and juniors from Columbus, Ohio, metropolitan area high schools, with a blinded review process and no grade point averages requirement to encourage broad participation. Evaluation included pre/post assessments, facilitator feedback, and daily safety checks, with IRB exemption secured for toolkit development and dissemination.</p><p><strong>Results: </strong>Within one month, we received 100 applications from 14 schools, far exceeding expectations, and selected 34 students from 8 Columbus, Ohio, metropolitan area high schools. Of the 34 accepted, 33 participated in most elements of the program and 29 students completed all four days of camp and post-camp evaluations, with an average self-reported goal achievement score of 8.41 out of 10. Pre- and post-test results showed statistically significant increases in confidence across clinical research topics.</p><p><strong>Discussion/conclusion: </strong>The pilot summer camp for high school students, supported by in-kind contributions, successfully met its goals and led to the creation of a replicable summer camp toolkit. The camp laid a strong foundation for future offerings and collaborations, with ongoing efforts to secure funding and expand access and impact.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e46"},"PeriodicalIF":2.7,"publicationDate":"2026-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12975623/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147443988","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A tool to evaluate the integration of implementation science methods in a research project: The Dissemination and Implementation Research Capability Self Survey (DIRC-SS).","authors":"Heather J Gotham, Briana M Patrick, Praise F Olatunde, Jane P Kim, Helene Chokron Garneau, Sara J Becker, C Hendricks Brown, William C Becker, Mark P McGovern","doi":"10.1017/cts.2026.10711","DOIUrl":"10.1017/cts.2026.10711","url":null,"abstract":"<p><strong>Introduction: </strong>Clinical and Translational Science Awards (CTSAs) are positioned to enhance the integration of rigorous implementation research methods into projects across their networks, but lack a systematic, standardized process to do so. This study introduces the Dissemination and Implementation Research Capability Self Survey (DIRC-SS), a pragmatic instrument to evaluate and integrate implementation science methods in traditional research activities.</p><p><strong>Methods: </strong>We developed the 15-item DIRC-SS to assess researchers' use of implementation research methods across five key constructs. Its reliability (inter-rater agreement and internal consistency) and sensitivity (change over time) were examined in 10 NIH-funded research projects via ratings assigned by the research teams and by implementation science experts at baseline and one year later.</p><p><strong>Results: </strong>The DIRC-SS total score demonstrated good internal consistency and inter-rater reliability increased over one year. Although the research team ratings did not change significantly over time, the expert ratings significantly increased, and effect sizes across research teams and expert raters were large in this small sample study.</p><p><strong>Conclusions: </strong>The DIRC-SS demonstrated good internal consistency reliability and moderate inter-rater reliability. It effectively distinguished between different levels of implementation research methods integration. Unlike tools focused on grant proposals or final reports, the DIRC-SS can be used at any point in the research process by a research team as a self-survey, by implementation science experts in a consultation process, or across a CTSA program to characterize the implementation science methods employed across projects and highlight targeted areas for researcher education and training.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e55"},"PeriodicalIF":2.7,"publicationDate":"2026-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13040393/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147609002","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dental, Oral and Craniofacial Tissue Regeneration Consortium (DOCTRC): An infrastructure for accelerating regenerative therapies from discovery to clinical impact.","authors":"VyVy Xuan Nguyen, Mutsumi Yoshida, Bridget D Samuels, William Giannobile, Kevin E Healy, Michael Jamieson, Nancy Lane, Michael T Longaker, David J Mooney, Charles S Sfeir, Uttam K Sinha, William R Wagner, Jeffrey C Lotz, David H Kohn, Yang Chai","doi":"10.1017/cts.2026.10706","DOIUrl":"10.1017/cts.2026.10706","url":null,"abstract":"<p><p>Translating scientific discoveries in tissue engineering and regenerative medicine (TE/RM) into clinically adopted therapies is hindered by fragmented development pipelines, regulatory and manufacturing challenges, and limited funding. Despite substantial investment by the U.S. National Institutes of Health (NIH), few NIH-funded TE/RM projects achieve commercialization or regulatory approval by the US Food and Drug Administration. The gap between academic innovation and clinical implementation is particularly evident in the dental, oral, and craniofacial (DOC) domain, where market and reimbursement constraints further restrict translation. To address these barriers, the National Institute of Dental and Craniofacial Research established the Dental, Oral and Craniofacial Tissue Regeneration Consortium (DOCTRC), comprising two nationwide Resource Centers tasked with guiding promising technologies from universities and small businesses through preclinical validation toward clinical adoption. This translational science case study outlines DOCTRC's translational model, highlighting lessons learned from five cohorts of interdisciplinary translational project teams, strategies for navigating manufacturing and regulatory pathways, and approaches for aligning academic innovation with clinical and market needs. The unique impact of the DOCTRC framework demonstrates how disciplined product development activities, non-dilutive funding mechanisms, and a comprehensive support ecosystem can accelerate technology translation, offering a scalable model for other biomedical fields.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e38"},"PeriodicalIF":2.7,"publicationDate":"2026-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12972584/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147433146","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Using a participation monitoring database to enhance recruitment in a rare cancer population.","authors":"Michael A O'Rorke, Brian M Gryzlak, Tao Xu, Bradley D McDowell, Rhonda R DeCook, Nicholas J Rudzianski, Kimberly C Serrano, Abigayle M Wehrheim, Udhayvir S Grewal, Chandrikha Chandrasekharan, Joseph S Dillon, Thorvardur R Halfdanarson, Michael J Schnell, Carrie L Witter, T Clark Gamblin, Syed Kazmi, Lindsay G Cowell, Tobias Else, Heloisa P Soares, Vineeth Sukrithan, Sravani Chandaka, Hanna K Sanoff, Fiona C He, David A Geller, Robert A Ramirez, Mei Liu, William Lancaster, Josh A Mailman, Heather Moran, Maryann Wahmann, Elyse Gellerman, Elizabeth A Chrischilles","doi":"10.1017/cts.2026.10703","DOIUrl":"10.1017/cts.2026.10703","url":null,"abstract":"<p><strong>Introduction: </strong>Recruitment for rare disease studies is challenging due to small eligible populations. Traditional clinical research management systems often lack tools to track recruitment contacts prior to enrollment. The NET-PRO study, focused on neuroendocrine tumors (NETs), implemented a participation monitoring system to enhance recruitment efficiency and representativeness.</p><p><strong>Methods: </strong>NET-PRO is a multicenter cohort study of 2538 adults diagnosed with gastroenteropancreatic (GEP) or lung NETs between January 2018 and September 2024. Recruitment occurred from January 2022 to February 2025 across 14 U.S. medical centers. Sites used flexible recruitment methods (email, mail, phone, in-clinic) and tracked contacts using REDCap-based tools. Participant characteristics were analyzed by enrollment mode (online or mail) and recruitment difficulty (number of contacts required prior to enrollment) using standardized mean differences, chi-square tests, and ANOVA.</p><p><strong>Results: </strong>Of 9279 contacted patients, 2675 consented (28.8%) and 2538 enrolled (27.4%). Most enrolled online (83.2%), while 16.8% enrolled by mail. Mail respondents were older, had lower education and income, and more comorbidities. Among those enrolled, recruitment difficulty was associated with older age, lower education and income, but not comorbidity. Over half of the most difficult-to-recruit participants enrolled online. Contact methods varied by attempt, with email dominating early contacts and phone/mail used more in later attempts.</p><p><strong>Conclusions: </strong>A participation monitoring tool supported flexible, multimodal recruitment and improved sample representativeness in a rare cancer study. Tracking recruitment contacts enabled adaptive strategies and may reduce bias in observational research by enabling better outreach to harder-to-reach populations.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e40"},"PeriodicalIF":2.7,"publicationDate":"2026-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12975625/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147443596","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient perspective of Hesitancies and strategies to increase cancer clinical trial participation.","authors":"Bre-Anne Fifield, Allison Baker, Omer Elkhidir, Nick Philbin, Isabelle Hinch, Nora McVinnie, Amy Llancari, Claudia Pecoraro, Mahsa Rahimi, Tiana Visconti, Alexandra Shoust, Suzanne McMurphy, Kendall Soucie, Caroline Hamm, Lisa A Porter","doi":"10.1017/cts.2026.10695","DOIUrl":"10.1017/cts.2026.10695","url":null,"abstract":"<p><strong>Introduction: </strong>Strategies to improve accrual and reduce barriers to cancer clinical trials participation are critical for the advancement and implementation of new treatments and processes to improve cancer patient outcomes. While researchers have identified several barriers to accrual from the perspective of health care providers and patients, mechanisms to address and alleviate these concerns are needed to increase participation and interest in clinical trials.</p><p><strong>Methods: </strong>A focus group of 9 people with lived experience of a cancer diagnosis were accrued randomly and provided with a hands-on research experience and educational resources about clinical trials, followed by a focused group discussion to capture perspectives and/or experiences with clinical trials. Focus groups were transcribed and analyzed via Braun & Clarke's 6-phase reflexive thematic analysis.</p><p><strong>Results: </strong>Five key themes were identified as important to increase clinical trial accrual. These included a patient-centered approach, easily digestible educational resources, a personalized understanding of motivating factors, local outreach, and transparency on outcomes and progress of the work. Qualitative input also identified methods that could positively influence accrual rates.</p><p><strong>Conclusions: </strong>Providing participants with opportunities to see first-hand how research works and data are used was noted as an overwhelmingly positive experience that could improve clinical trial accrual rates. This work confirms several previous findings with respect to patient identified barriers to participation in clinical trials and provides support and a framework for development of knowledge translation strategies to increase awareness and knowledge of the importance of clinical research to improve health outcomes for cancer patients.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e39"},"PeriodicalIF":2.7,"publicationDate":"2026-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12975619/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147444032","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"\"I want to see everything\": A community-based participatory research framework to identify eye health and vision care knowledge, perceptions, values, and barriers.","authors":"Sarah Koopman Gonzalez, Sara Kennedy, Tyler A West, Kendall R Pixley, Andrea R Waksmunski, Kaitlyn L Funk, Leslie V Castaneda, Leslie Richards, Leah Cummings, Bridget Croniger Ockunzzi, Renee A Laux, Briana L McIntosh, Earl Pike, Erika S Trapl, Jessica N Cooke Bailey","doi":"10.1017/cts.2026.10698","DOIUrl":"10.1017/cts.2026.10698","url":null,"abstract":"<p><strong>Introduction: </strong>Vision impairment disproportionately affects individuals from low-income and African American communities, yet underutilization of preventive eye care persists. We conducted a community-based participatory research (CBPR) study to explore perceptions, values, and barriers related to vision care in an underserved urban neighborhood.</p><p><strong>Methods: </strong>In partnership with University Settlement, a trusted community center in Cleveland, Ohio, and a study-specific Community Advisory Board (CAB), we conducted semi-structured interviews with 60 adult residents of the Broadway-Slavic Village neighborhood. Thematic analysis identified key facilitators and barriers to accessing vision care.</p><p><strong>Results: </strong>Participants across racial groups described vision as highly important and often endorsed more frequent preventive eye care than they reported receiving. Barriers to eye care utilization included cost, inadequate insurance coverage, transportation challenges, fear of diagnosis, and limited awareness of preventive benefits. Distinct differences emerged in insurance type and visit frequency between African American and White participants despite comparable socioeconomic status. Participants identified community-specific solutions such as free or low-cost exams, mobile clinics, transportation support, and increased education.</p><p><strong>Conclusions: </strong>Our findings demonstrate that underutilization of eye care reflects structural and systemic barriers rather than lack of motivation. System-level interventions that integrate screenings into clinical and community settings, streamline referral pathways, and reduce logistical burdens are needed to facilitate equitable access to vision care. Embedding data collection in a trusted community setting surfaced perspectives from individuals who may be absent from clinic-based or online research and provides a model for translational research addressing health disparities.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e51"},"PeriodicalIF":2.7,"publicationDate":"2026-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13040302/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147608925","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Remote data collection to detect asthma exacerbations: A decentralized approach to clinical research in asthma.","authors":"Allison J Burbank, Jeremy Owens, Andre Espaillat, Claire E Atkinson, Stephen A Schworer, Katherine M Whaylen, Kelly Chason, Michelle L Hernandez","doi":"10.1017/cts.2026.10697","DOIUrl":"10.1017/cts.2026.10697","url":null,"abstract":"<p><strong>Background: </strong>Decentralized trial designs can improve accessibility and continuity of research participation by enabling remote data collection. This manuscript describes our team's experiences with remote data collection to identify acute asthma exacerbations in a clinical study as well as practical insights that support the continued optimization of remote methodologies.</p><p><strong>Methods: </strong>In this 12-month observational study, adolescents aged 12-21 years with persistent asthma and ≥1 exacerbation in the prior 24 months completed an initial in-person visit followed by monthly virtual visits. Participants used home spirometry, app-based symptom tracking, smart inhalers to monitor lung function and short-acting beta agonist (SABA) use, and self-collection of nasal epithelial lining fluid (NELF) samples. Exacerbations were defined <i>a priori</i> by symptom/SABA thresholds or ≥20% FEV₁ decline.</p><p><strong>Results: </strong>Forty participants enrolled; 73% completed all visits. Median adherence to performance of daily spirometry and symptom surveys was 44% and 38%, respectively. Seventy-eight percent experienced ≥1 exacerbation. Of 132 alerts, 80% represented true exacerbations, primarily due to ≥20% FEV₁ decline; erroneous alerts were linked to software errors and poor spirometry technique. Sixty-six NELF sample sets were collected and 50 were analyzed. Cytokine concentrations did not differ significantly between clinic-collected and self-collected samples. Technical challenges included device connectivity issues, erroneous alerts, and shipping delays.</p><p><strong>Conclusions: </strong>Decentralized study designs with remote data collection requires further study as a means of conducting clinical research in asthma that increases participant accessibility, representation and generalizability of trial results. This approach presents numerous challenges and requires further optimization to address adherence, technical complexity, and staff burden while maintaining scientific rigor.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e35"},"PeriodicalIF":2.7,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12957659/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147365477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reframing advisory as leadership to promote equity in trauma-informed community-engaged research: A case study of Yolo County, CA.","authors":"Leigh Ann Simmons, Jasmine Cuellar, Jennifer Phipps","doi":"10.1017/cts.2026.10693","DOIUrl":"10.1017/cts.2026.10693","url":null,"abstract":"<p><strong>Background: </strong>Community engagement that emphasizes shared leadership is essential in clinical and translational science, and language, naming, and framing have the potential to shape power dynamics. This study explored how renaming and restructuring a Community Advisory Board (CAB) into a Community Leadership Board (CLB) could strengthen a trauma-informed network of care (TINoC) by elevating community power, cultural responsiveness, and equitable participation.</p><p><strong>Methods: </strong>Guided by the Trauma and Resilience Informed Research Principles and Practice(TRIRPP) framework, we established a paid CLB in Yolo County, California, composed of six individuals who identified as members of groups underrepresented in science. We reviewed timesheets and TINoC products and conducted an inductive thematic analysis of meeting minutes to determine the CLB's main areas of influence.</p><p><strong>Results: </strong>The CLB met 25 times over two years, provided iterative feedback on more than a dozen educational materials, clinical workflows, trauma-informed trainings, and communication strategies, and co-presented at community meetings. Eight recurring areas of influence were identified: trauma-informed ACE screening, accessibility, workflow feasibility, community- and patient-centered feedback, health communication, participant compensation, engagement, and post-screening navigation. CLB members highlighted gaps not identified by the academic and community members of the TINoC, including translation accuracy, time allowed for ACE screening, and ensuring voluntary patient participation.</p><p><strong>Conclusions: </strong>Renaming the CLB as a \"leadership\" body signaled a shift in accountability, deepened engagement, and underscored how naming practices can drive more equitable translational research. Virtual-only meetings potentially limited the representativeness of the CLB; however, results suggest naming is a critical component of trauma-informed community-engaged research(CEnR).</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e34"},"PeriodicalIF":2.7,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12964070/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147377579","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Expanding access to genomic analysis and reporting in research studies: The GENYSIS research core.","authors":"Kimberly S Foss, Tam P Sneddon, Eleanor P Fensterle, Scott A Melville, Mai Xiong, Christopher W Gregory, Paul Greenwood, Kelly A Rafferty, Elizabeth K Hutchins, Neeta L Vora, Kelly L Gilmore, Senyene E Hunter, Karen E Weck, Jonathan S Berg, Bradford C Powell","doi":"10.1017/cts.2026.10696","DOIUrl":"10.1017/cts.2026.10696","url":null,"abstract":"<p><strong>Introduction: </strong>The growing utility and availability of genome-scale sequencing has led to increasingly broad incorporation across specialty disciplines of clinical research. However, classification of clinical relevance of genetic variation is an inherently clinical task, and the expertise to perform the necessary analysis, confirmation and reporting of these variants is not available in all research teams; consequently, disclosure of genomic variants to research participants remains challenging for many researchers. Advancing genomic medicine as a standard of care first requires institutional commitment and partnerships in supporting genomics in varied research studies that are inclusive of return of results to participants.</p><p><strong>Materials and methods: </strong>The University of North Carolina at Chapel Hill has vast experience with genetics in both clinical and research realms. By utilizing historical experience and input from key players, the Clinical GENomic analYSIS (GENYSIS) core facility was created as a case study and aims to provide a roadmap for research organizations to implement their own genomic sequencing core facilities.</p><p><strong>Results: </strong>The core has established a molecular sign-out conference, partnered with other core facilities on campus, and provides five main services: bioinformatics, variant analysis, clinical reporting, post-test services, and consultation with project advising. This paper presents case examples with discussion of continuous methodology improvements and embedded educational activities.</p><p><strong>Conclusion: </strong>This novel shared research resource enables clinical researchers with limited staff and genomics expertise to provide clinically relevant results to their study participants, expanding the reach of genomics research.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e54"},"PeriodicalIF":2.7,"publicationDate":"2026-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13058758/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147645588","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}