Journal of Clinical and Translational Science最新文献_第3页

The Forge AHEAD Center Pilot Plus program: An integrated framework combining pilot funding, training, and community-engaged translational science. Forge AHEAD中心试点+项目：一个结合试点资金、培训和社区参与的转化科学的综合框架。

IF 2.7

Journal of Clinical and Translational Science Pub Date : 2026-06-25 eCollection Date: 2026-01-01 DOI: 10.1017/cts.2026.10779

Michael Mugavero, Rikki M Tanner, Trudi V Horton, April A Agne, Robert L Newton, Denise C Cornelius, Timothy Turner, Andrea L Cherrington, Gareth Dutton, Larry R Hearld, Carrie R Howell, Tina Kempin Reuter, Maria Pisu, Jeffery Walker, Orlando M Gutierrez

{"title":"The Forge AHEAD Center Pilot Plus program: An integrated framework combining pilot funding, training, and community-engaged translational science.","authors":"Michael Mugavero, Rikki M Tanner, Trudi V Horton, April A Agne, Robert L Newton, Denise C Cornelius, Timothy Turner, Andrea L Cherrington, Gareth Dutton, Larry R Hearld, Carrie R Howell, Tina Kempin Reuter, Maria Pisu, Jeffery Walker, Orlando M Gutierrez","doi":"10.1017/cts.2026.10779","DOIUrl":"10.1017/cts.2026.10779","url":null,"abstract":"The Deep South has the highest prevalence of obesity, diabetes, and hypertension in the United States, with marked disparities by race, socioeconomic status, and rurality. Addressing these disparities requires not only effective interventions, but also a translational science workforce equipped to design, implement, and scale solutions in real-world settings. The Forge AHEAD Center was established to improve cardiometabolic health outcomes across the Deep South by advancing both research and scientific workforce development. As a central component of this mission, the Center has developed the \"Pilot Plus\" model, an integrated framework that combines pilot funding with structured training in translational science, multidisciplinary team-based mentorship, and embedded community engagement. Early-stage investigators are supported through coordinated access to methodological expertise, including dissemination and implantation science and assessment of social determinants of health, while community stakeholders are incorporated into the research process. By aligning funding, training, and infrastructure within a single program, the Pilot Plus model addresses fragmentation in traditional research development approaches and expands access to critical resources across institutions. This model provides an adaptable framework for strengthening translational research capacity and developing a cadre of demographically varied investigators prepared to advance health outcomes in regions with a high burden of chronic disease.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e126"},"PeriodicalIF":2.7,"publicationDate":"2026-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13420194/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148630512","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}

引用次数: 0

The sponsor-proxy model: Bridging basic science discovery and investigator-initiated clinical trials. 赞助者-代理模型：连接基础科学发现和研究者发起的临床试验。

IF 2.7

Journal of Clinical and Translational Science Pub Date : 2026-06-24 eCollection Date: 2026-01-01 DOI: 10.1017/cts.2026.10782

Xin Liu, Doris Shank, Junxuan Lü, Monika Joshi

{"title":"The sponsor-proxy model: Bridging basic science discovery and investigator-initiated clinical trials.","authors":"Xin Liu, Doris Shank, Junxuan Lü, Monika Joshi","doi":"10.1017/cts.2026.10782","DOIUrl":"10.1017/cts.2026.10782","url":null,"abstract":"Translating academic discoveries into clinical investigation remains a major barrier in translational science, particularly when investigators lack the regulatory infrastructure required to sponsor clinical trials. These challenges are especially pronounced for natural product therapeutics, which often lack commercial sponsorship despite promising preclinical evidence. The Penn State Cancer Institute established an Investigator-Initiated Trial Sponsor Support Unit (SSU) to facilitate investigator-initiated trials and support progression toward National Cancer Institute designation. We describe a translational science case study of a Sponsor-Proxy operational model in which a centralized institutional unit performs sponsor-level regulatory and trial infrastructure functions while investigators retain scientific and clinical leadership. Two National Institutes of Health-funded trials evaluating Angelica gigas Nakai extract (INM176) illustrate this framework. The SSU authored regulatory documentation including Investigator's Brochures, coordinated Investigational New Drug submissions, and supported trial infrastructure while clinical teams maintained participant oversight. Both trials achieved activation timelines of 112 and 105 days, shorter than previously reported activation times and within National Cancer Institute operational benchmarks. Sponsor-level oversight continued throughout trial conduct, including regulatory reporting, safety monitoring, and protocol amendment support. This case study demonstrates how centralized institutional expertise can overcome sponsor-level barriers and enable translation of basic science discoveries into investigator-initiated early-phase clinical trials.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e127"},"PeriodicalIF":2.7,"publicationDate":"2026-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13420145/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148630569","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}

引用次数: 0

A case study of enhancing bidirectional feedback between research programs and an institutional community engagement advisory board. 加强研究项目与机构社区参与咨询委员会之间双向反馈的案例研究。

IF 2.7

Journal of Clinical and Translational Science Pub Date : 2026-06-24 eCollection Date: 2026-01-01 DOI: 10.1017/cts.2026.10780

Helen H Lee, Teresa Borowski, Marc S Atkins, Devyani Gore, Joanna Buscemi

引用次数: 0

Untargeted metabolomics of cervicovaginal fluid in patients with ovarian cancer. 卵巢癌患者宫颈阴道液的非靶向代谢组学研究

IF 2.7

Journal of Clinical and Translational Science Pub Date : 2026-06-22 eCollection Date: 2026-01-01 DOI: 10.1017/cts.2026.10766

Oyomoare L Osazuwa-Peters, April Deveaux, Brandon Eudy, Temitope Keku, Andrew Berchuck, Ashwini Joshi, Bin Huang, Thomas Tucker, Kevin Ward, Maria Pisu, Margaret Gates Kuliszewski, Rebecca A Previs, Tomi Akinyemiju

引用次数: 0

Social media toolkit for recruiting clinical research participants: A new resource from the Recruitment Innovation Center. 招募临床研究参与者的社会媒体工具包：来自招聘创新中心的新资源。

IF 2.7

Journal of Clinical and Translational Science Pub Date : 2026-06-18 eCollection Date: 2026-01-01 DOI: 10.1017/cts.2026.10775

Sarah Cook, Stephanie Mayers, Matt Schorr, Caitlin Rantala, Sophia Gomez, Meghan Vance, Danielle Pardue, Terri L Edwards, Mary Stroud, Paul A Harris, Consuelo Wilkins

引用次数: 0

The All of Us Evenings with Genetics Research Program. 我们所有人的夜晚遗传学研究项目。

IF 2.7

Journal of Clinical and Translational Science Pub Date : 2026-06-16 eCollection Date: 2026-01-01 DOI: 10.1017/cts.2026.10763

Stacy M Lloyd, Jasmine Baker, Carolina Jorgez, Julie Coleman, LaTerrica Williams, April Adams, Ashley Butler, Elizabeth Atkinson, Shamika Ketkar, Steven Scherer, Kim Worley, Susan Fernbach, Keasia Daniels, Latanya Hammonds-Odie, Laura Rosales, Brendan Lee, Debra Murray

{"title":"The All of Us Evenings with Genetics Research Program.","authors":"Stacy M Lloyd, Jasmine Baker, Carolina Jorgez, Julie Coleman, LaTerrica Williams, April Adams, Ashley Butler, Elizabeth Atkinson, Shamika Ketkar, Steven Scherer, Kim Worley, Susan Fernbach, Keasia Daniels, Latanya Hammonds-Odie, Laura Rosales, Brendan Lee, Debra Murray","doi":"10.1017/cts.2026.10763","DOIUrl":"10.1017/cts.2026.10763","url":null,"abstract":"The All of Us Evenings with Genetics (All of Us EwG) Research Program, funded in part by the National Institute of Health's All of Us Research Program, engages researchers to utilize the All of Us Researcher Workbench to advance precision medicine. The All of Us EwG program has two core aims: (1) address barriers to research productivity for minorities, disadvantaged, and persons with disabilities aspiring to enter STEM fields; and (2) promote the use of the All of Us Researcher Workbench to develop research focused on health equity. To achieve these goals, the program implements three key activities: (1) Campus Seminars: hosted at minority-serving institutions and smaller universities to connect faculty with the All of Us Research Program to showcase ongoing research; (2) Biomedical Researchers Faculty Summit: a multi-day conference for early career researchers to foster collaboration and train participants in using the All of Us database; and (3) Biomedical Researcher Scholars Program: A yearlong initiative supporting the research teams formed at the summit in implementing the research projects developed using the All of Us data. Overall, the All of Us EwG program offers data science training, mentorship, and professional development; this report outlines its structure, outcomes, and lessons learned.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e125"},"PeriodicalIF":2.7,"publicationDate":"2026-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13420164/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148630401","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}

引用次数: 0

Evaluating confidence in translational science principles to guide workforce development. 评估对转化科学原则的信心，以指导劳动力发展。

IF 2.7

Journal of Clinical and Translational Science Pub Date : 2026-06-15 eCollection Date: 2026-01-01 DOI: 10.1017/cts.2026.10772

Darcy A Freedman, Holly E Hartman, Emily S Nelson, Ann Pearman

{"title":"Evaluating confidence in translational science principles to guide workforce development.","authors":"Darcy A Freedman, Holly E Hartman, Emily S Nelson, Ann Pearman","doi":"10.1017/cts.2026.10772","DOIUrl":"10.1017/cts.2026.10772","url":null,"abstract":"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.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e116"},"PeriodicalIF":2.7,"publicationDate":"2026-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13373602/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148470989","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}

引用次数: 0

Development of a pediatric urgent care research infrastructure to facilitate human immunology studies. 发展儿科紧急护理研究基础设施，以促进人类免疫学研究。

IF 2.7

Journal of Clinical and Translational Science Pub Date : 2026-06-15 eCollection Date: 2026-01-01 DOI: 10.1017/cts.2026.10773

John J Santos, Alexandra C Keefe, Richard Torres, Gerson Zaragoza, Caitlin Ginn, Nia Barr-Jeffrey, Holly Barrett, Phoenicia Quach, Katherine Grubb, Whitney E Harrington, Blair Armistead

{"title":"Development of a pediatric urgent care research infrastructure to facilitate human immunology studies.","authors":"John J Santos, Alexandra C Keefe, Richard Torres, Gerson Zaragoza, Caitlin Ginn, Nia Barr-Jeffrey, Holly Barrett, Phoenicia Quach, Katherine Grubb, Whitney E Harrington, Blair Armistead","doi":"10.1017/cts.2026.10773","DOIUrl":"10.1017/cts.2026.10773","url":null,"abstract":"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.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e114"},"PeriodicalIF":2.7,"publicationDate":"2026-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13373604/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148470939","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}

引用次数: 0

Preferences of research participants with experience receiving individual results for future return of results. 具有接受个人结果经验的研究参与者对未来结果返回的偏好。

IF 2.7

Journal of Clinical and Translational Science Pub Date : 2026-06-15 eCollection Date: 2026-01-01 DOI: 10.1017/cts.2026.10768

Paul S Appelbaum, Sheila Marie OByrne, Zirui Zhang, Wendy K Chung, George Hripcsak, Krzysztof Kiryluk, Chunhua Weng, Shing Lee, Nancy S Green

{"title":"Preferences of research participants with experience receiving individual results for future return of results.","authors":"Paul S Appelbaum, Sheila Marie OByrne, Zirui Zhang, Wendy K Chung, George Hripcsak, Krzysztof Kiryluk, Chunhua Weng, Shing Lee, Nancy S Green","doi":"10.1017/cts.2026.10768","DOIUrl":"10.1017/cts.2026.10768","url":null,"abstract":"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.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e109"},"PeriodicalIF":2.7,"publicationDate":"2026-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13373603/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148470959","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}

引用次数: 0

Representation of women and historically underserved populations in hypertension and diabetes clinical trials at Federally Qualified Health Centers: A systematic review and meta-analysis. 联邦合格医疗中心高血压和糖尿病临床试验中女性和历史上服务不足人群的代表性：系统回顾和荟萃分析

IF 2.7

Journal of Clinical and Translational Science Pub Date : 2026-06-06 eCollection Date: 2026-01-01 DOI: 10.1017/cts.2026.10759

Rifath Ara Alam Barsha, Samuel Byiringiro, Thomas Hinneh, Emmanuel Uwiringiyimana, Juliana Garcia, Kimesha Grant, Oluwatosin Tomiwa, Khadijat Adeleye, Brenda Owusu, Yuling Chen, Diana-Lyn Baptiste, Ashwag Alhabodal, Serina Gbaba, Payam Sheikhattari, Hailey N Miller, Cheryl R Dennison Himmelfarb

{"title":"Representation of women and historically underserved populations in hypertension and diabetes clinical trials at Federally Qualified Health Centers: A systematic review and meta-analysis.","authors":"Rifath Ara Alam Barsha, Samuel Byiringiro, Thomas Hinneh, Emmanuel Uwiringiyimana, Juliana Garcia, Kimesha Grant, Oluwatosin Tomiwa, Khadijat Adeleye, Brenda Owusu, Yuling Chen, Diana-Lyn Baptiste, Ashwag Alhabodal, Serina Gbaba, Payam Sheikhattari, Hailey N Miller, Cheryl R Dennison Himmelfarb","doi":"10.1017/cts.2026.10759","DOIUrl":"10.1017/cts.2026.10759","url":null,"abstract":"Introduction: Federally Qualified Health Centers (FQHCs) serve diverse populations and may enhance participant diversity in clinical trials; however, their engagement in trials remains understudied. The objective of the current study was to examine participant diversity in hypertension (HTN) and type-2 diabetes (T2D) clinical trials.Methods: We searched PubMed, Cochrane, CINAHL (Cumulative Index of Nursing and Allied Health Literature), Web of Science, Embase, and Scopus for clinical trials of medical interventions addressing HTN or T2D among adults (≥18), engaging one or multiple FQHCs, and published between 2013 and 2023. We reported pooled proportions of representation of underserved populations in clinical trials.Results: Of 4552 articles identified, 26 clinical trials were included. The pooled proportion was 0.35 (95% CI: 0.26, 0.45) for Hispanic, 0.36 (95% CI: 0.23, 0.48) for Black/African American, 0.03 (95% CI: 0.02, 0.05) for Asian, 0.58 (95% CI: 0.54, 0.63) for female, and 0.25 (95% CI: 0.07, 0.43) for uninsured participants, and 0.54 (95% CI: 0.36, 0.72) for people with limited education (≤high school).Conclusion: Trials involving FQHCs demonstrated high inclusion of historically underrepresented than typical trial populations. This underscores the potential of FQHCs to improve clinical trial representativeness and to enhance the generalizability of research findings.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e107"},"PeriodicalIF":2.7,"publicationDate":"2026-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13373607/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148471007","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}

引用次数: 0