Abstract Introduction: Persistent challenges with clinical trial enrollment and retention limit the extent to which novel approaches are translated into clinical and community practice for real-world benefit. Community engagement is one strategy that may improve enrollment and retention. The current study sought to 1) describe the extent to which clinical trials utilized specific levels of community engagement and 2) examine associations between level of community engagement and study process outcomes. We hypothesized that clinical trials with higher levels of community engagement would have more successful participant enrollment and retention. Methods: Using manifest content analysis, we examined associations between community engagement strategies and three study process outcomes: total enrollment, time to full enrollment, and retention, as documented on ClinicalTrials.gov. Results: Of 619 studies that met inclusion criteria, 349 published findings, of which only eight studies described any community engagement. The eight studies with publications that described community engagement had higher actual enrollments and shorter time to full enrollment than studies without any description of community engagement in their associated publications. Conclusions: Results demonstrate positive associations between documented community engagement and enrollment in clinical trials. Community engagement has strong promise for increasing the efficiency and real-world impact of clinical research. However, findings revealed the infinitesimal number of clinical trials that utilized community engagement and the rarity of co-leadership.
Abstract Biostatistical methods are currently one of the cornerstones of modern health sciences research. Open-source statistical programs are powerful, free tools for data management and advanced statistical analysis. JASP is one of the main open-source statistical software currently available worldwide. One of the possible facilitators for a broader use of open statistical software might be the availability of basic tutorials, which might be quite helpful for novel users. In this manuscript, we provide a user-friendly tutorial for basic statistical analyses using the open JASP software. The following statistical analyses are covered, with examples of the respective menus and of the resulting tables and figures: Descriptive statistics, normality testing, comparison of means between two groups, comparison of means between three or more groups, contingency tables and Pearson correlation. Promoting and facilitating, through detailed tutorials, the adequate implementation of user-friendly and open statistical software might contribute to the training of scientists around the world. The use of open software, in addition to facilitating access to researchers in environments with limited economic resources, has advantages in terms of reproducibility and transparency.
Abstract Informed consent remains a persistent challenge in clinical research, as traditional processes often fail to ensure participant understanding and voluntariness. We developed and evaluated an artificial intelligence (AI)-driven consent process utilizing large language models to conduct interactive, participant-centered consent conversations. The system’s scalability, auditability, and capacity to tailor communication may address barriers to informed consent. In silico testing with simulated participants demonstrated high rates of successful teach-back across consent concepts, with auditability and adherence to predefined ethical and procedural safeguards. These simulation-based results support pilot testing of AI-driven consent processes to evaluate their potential to enhance participant understanding, autonomy, and trial accessibility.
Objectives/Goals: Our objective in this study was to develop a nanoparticle-based RNA delivery system that reprograms Müller glia toward neuronal fates in human relevant models, enabling localized and transient regeneration without viral vectors. Methods/Study Population: - Results/Anticipated Results: Fabricated nanoparticles encapsulating RNA cargoes were ~110–150 nm in size with polydispersity indices of ~0.2–0.3 and encapsulation efficiencies >95%. Nanoparticles successfully delivered GFP mRNA in both organoid and retinal explant models, showing significant expression of fluorescent reporters in both live cell imaging and in slides prepared using immunohistochemistry. We anticipate that our delivery system will lead to transcription factor expression after delivery of corresponding RNAs with evidence of proliferation and neuronal marker upregulation. We also hypothesize that this approach will enhance neurogenesis in retinal organoids and explants, potentially establishing a platform for non-viral retinal regeneration. Discussion/Significance of Impact: This work demonstrates a clinically translatable, virus-free strategy for retinal repair through targeted RNA delivery. By enabling transient expression of neurogenic factors, nanoparticle-mediated reprogramming presents a scalable and adaptable approach for restoring vision in degenerative retinal diseases.
