Journal of Clinical and Translational Science最新文献

[This corrects the article DOI: 10.1017/cts.2025.10133.].

Cooperative Extension provides research-based outreach to the public, making it a valuable resource for translation scientists. Herein, we describe a collaboration between Cooperative Extension and the Department of Nutritional Sciences at Pennsylvania State University that resulted in widespread dissemination of novel nutrition education materials. Short videos (3 to 5 minutes each) for the public, healthcare professionals and patients focused on using spices and herbs (S&H) to decrease sodium, saturated fat (SFA), and added sugars, and improve diet quality were developed and evaluated. The videos were effective in improving knowledge about S&H, intent to use them, and making healthy diet changes.

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.

Introduction: Clinical translational research relies on clinical research professional staff, and efforts to stimulate a future workforce has included outreach to high schools.

Methods: 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.

Results: 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.

Discussion/conclusion: 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.

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.

Introduction: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Introduction: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Background: 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.

Methods: 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 a priori by symptom/SABA thresholds or ≥20% FEV₁ decline.

Results: 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.

Conclusions: 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.

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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).