Objectives/Goals: To develop a personalized computational framework integrating computational fluid dynamics (CFD) and topology optimization for designing intracranial aneurysm implants. The primary objective is to reduce intra-aneurysmal blood flow velocity and enhance thrombus formation for improved treatment outcomes. Methods/Study Population: Patient-specific aneurysm geometries were extracted from pre-treatment rotational angiograms. A CFD-driven topology optimization framework was employed to design implants that reduce intra-aneurysmal flow velocity. The fluid dynamics were modeled using Navier–Stokes equations and the structural integrity of the implants was ensured by linear elasticity equations. The solid isotropic material with penalization (SIMP) method was applied to optimize the implant’s porous architecture, balancing flow reduction with structural support. COMSOL Multiphysics software was used to implement the optimization. Results/Anticipated Results: The optimized implants demonstrated significant reductions in intra-aneurysmal blood flow velocity and improved hemodynamic conditions. Flow velocity within the aneurysm was reduced by 77%, and the fluid energy dissipation ratio showed a 78.9% improvement compared to pretreatment conditions. The optimized porous structures were tailored to the aneurysm’s specific geometry, providing personalized designs that improve flow stasis and thrombus formation. Further validation of the implants will be performed in vitro and in vivo to assess their effectiveness and biocompatibility. Discussion/Significance of Impact: This personalized implant design framework could lead to better treatment outcomes by reducing aneurysm recurrence and complications compared to current devices. It provides a pathway for improved occlusion rates and patient-specific solutions for intracranial aneurysms.

Objectives/Goals: Colorectal cancer (CRC) is classified into right-sided, left-sided, and rectal cancer. Clinicopathological and molecular features vary along the colorectum, even within subsites, leading to inconsistencies in identifying relevant biomarkers. We created a CRC metabolome map to explore diagnostic and survival heterogeneity across subsites. Methods/Study Population: A total of 372 patient-matched tumor and normal tissue samples were collected from seven colorectal subsites: cecum (n = 63), ascending colon (n = 44), transverse colon (n = 32), descending colon (n = 28), sigmoid colon (n = 75), rectosigmoid colon (n = 38), and rectum (n = 92). Liquid chromatography–mass spectrometry was used to compare metabolite abundances. Cox proportional hazards regression assessed metabolite impact on survival, adjusted for clinical covariates. Parametric and nonparametric tests were applied to compare the metabolite abundances. An interactive, publicly accessible online platform was developed to allow researchers to explore and generate hypotheses from this data. Results/Anticipated Results: Our study identified 39 and 70 significantly altered metabolites, including bile acids and lysophosphatidylcholines, across tumors and normal mucosa, showing metabolic heterogeneity between CRC subsites. We observed significant linear trends in metabolite gradients from the cecum to the rectum, and it was depended on the disease status. Comparison of tumors to patient-matched normal mucosa revealed metabolite changes exclusive to each subsite. Metabolite differences correlated with survival were unique to each subsite. Additionally, we developed an interactive, publicly accessible CRC metabolome database to share this valuable resource: https://colorectal-cancer-metabolome.com/yale-university. Discussion/Significance of Impact: This study provides the first CRC metabolome map, revealing metabolic differences across colorectal subsites. It challenges the right vs. left CRC classification, highlighting subsite-specific biomarker identification. Findings offer insights for personalized treatments tailored to the tumor type to improve patient outcomes.

Objectives/Goals: Lung transplant is a life-saving surgery for patients with advanced lung diseases yet long-term survival remains poor. The clinical features and lung injury patterns of lung transplant recipients who die early versus those who survive longer term remain undefined. Here, we use cell-free DNA and rejection parameters to help elucidate this further. Methods/Study Population: Lung transplant candidacy prioritizes patients who have a high mortality risk within 2 years and will likely survive beyond 5 years. We stratified patients who died within 2 years of transplant as early death (n = 50) and those who survived past 5 years as long-term survivors (n = 53). Lung transplant recipients had serial blood collected as part of two prospective cohort studies. Cell-free DNA (cfDNA) was quantified using relative (% donor-derived cfDNA {%ddcfDNA}) and absolute (nuclear-derived {n-cfDNA}, mitochondrial-derived {mt-cfDNA}) measurements. As part of routine posttransplant clinical care, all patients underwent pulmonary function testing (PFT), surveillance bronchoscopy with bronchoalveolar lavage (BAL), transbronchial biopsy (TBBx), and donor-specific antibody testing (DSA). Results/Anticipated Results: Over the first 2 years after transplant, the number of episodes of antibody-mediated rejection (p) Discussion/Significance of Impact: Clinically, early-death patients perform worse on routine surveillance PFTs and experience a worse degree of CLAD. These patients also have higher levels of cfDNA as quantified by n-cfDNA and mt-cfDNA. These results provide preliminary evidence that early-death patients have worse allograft rejection, dysfunction, and molecular injury.

Objectives/Goals: Identify risks in the regulatory reliance ecosystem, specifically for generic reliance pathways, using system theoretic process analysis (STPA), a proactive hazard analysis method, and create sustainable solutions to ensure global accessibility to the highest attainable standard of health. Methods/Study Population: A systematic literature review will assess the regulatory reliance ecosystem and interactions among National Regulatory Agencies (NRAs). This will involve using a hierarchical control structure (HCS) to identify operational loop failures, decision-making, and information flow. The HCS will inform an STPA to prevent adverse outcomes like patient harm or regulatory non-compliance. With IRB approval, 10 regulatory experts will also be interviewed to gather insights on risk scenarios. Their input will be used to integrate regulatory pathways into the HCS for adaptability, and a second round of interviews will be conducted to validate the scenarios and assess the effectiveness of recommendations. Results/Anticipated Results: A preliminary literature review on regulatory reliance pathways from PubMed, WHO guidelines, and the DIA global forum, revealed potential risks in NRA interactions, such as overly redacted reports obscuring critical details and discrepancies in product versions or incomplete reviews affecting evaluations. Diverging guidelines and failure to adapt to country-specific needs are potential risks that also impact patient access to essential medicines. The STPA framework, along with expert feedback, will uncover unknown risks like “secondary-reliance” and soft risks, leading to sustainable recommendations to improve and optimize the safety of regulatory reliance. Discussion/Significance of Impact: Safe regulatory reliance is crucial for global health equity and patient access to essential and innovative medicines. STPA will identify and address different layers of risk in the system, improving safety, efficiency, and innovation for timely patient access to therapeutics.

Objectives/Goals: This research aims to modify an existing regulatory benchmarking framework, initially designed for medical products, to assess cosmetic product regulations in different countries. This tool will provide qualitative and quantitative comparisons of global regulatory approaches to cosmetics. Methods/Study Population: The World Health Organization’s global benchmarking tool (GBT) was selected as a suitable template for the adapted methodology. The GBT contains a comprehensive set of functions, indicators, and sub-indicators defining the high regulatory maturity standard. Although the 269 sub-indicators are tailored to the regulation of medical products, they can be intentionally adapted for other products. Relevant indicators specific to cosmetic regulation will be identified to construct a customized benchmarking tool. This tool will then be used to assess the regulatory maturity of selected countries and regulatory authorities, including the United States, the European Union, Japan, India, Brazil, China, Ethiopia, and Nigeria. Results/Anticipated Results: Preliminary analysis indicates a lack of harmonized standards for regulatory maturity across the global cosmetic market. The recent passage of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has strengthened the United States’ regulatory framework, incorporating 11 of 13 adapted maturity indicators. The United States joins the European Union (10/13 indicators) and Japan (8/13 indicators) as leaders in cosmetic safety and manufacturing transparency. Common basic policies included good manufacturing practice regulations, while more advanced regulations cover adverse event reporting and premarket requirements. Discussion/Significance of Impact: Cosmetics, supplements, and homeopathic products lack transparency regarding safety and quality requirements. This project establishes a benchmark for cosmetic product regulation, addressing a historic gap in oversight. The benchmark supports regions with less developed regulatory policies to enhance cosmetic safety and quality standards.

Objectives/Goals: This study aims to gather user feedback from clinical research professionals on the usefulness and relevance of regulatory resources found on a new regulatory web portal, OpenRegSource, to enhance its usability, thereby advancing this project from the initial to the full implementation phase of the implementation science framework. Methods/Study Population: The Regulatory Knowledge and Support core of the Southern California Clinical and Translational Science Institute developed a regulatory web portal called OpenRegSource to help researchers gain basic regulatory information prior to professional and/or paid consultation. Before publicly launching, a virtual focus group (FG) composed of 21 members of the local clinical research workforce was given two weeks to explore the web portal and answer three surveys. Two other research professionals also gave feedback outside of the focus group. The user feedback data was analyzed and discussed by the web portal project team. Updates were then made accordingly. Once the portal was launched, a plan was implemented to collect usage metrics and additional feedback for continuous improvement. Results/Anticipated Results: Of the 21 FG participants, 20 completed the feedback survey specifically for their experience with the web portal. 65% (13/20) said the number of resources was just right. 90% (18/20) found the resources to be very relevant to their respective topics. 85% (17/20) found the resources very useful and somewhat useful to their daily work activities. 75% (15/20) found the organization of the portal to be good or very good. 85% (17/20) found it very easy and somewhat easy to navigate the web portal. 90% (18/20) found the portal to be effective in providing its audience with a basic understanding of regulatory requirements. 95% (19/20) found the portal useful for novice research professionals. 85% (17/20) found the web portal useful overall. Participants were also able to provide commentary feedback for specific pages. Discussion/Significance of Impact: Obtaining stakeholder input during the development of a resource or tool is essential to ensure the final product meets user needs and is effectively utilized. In this case, involving the feedback of clinical researchers will help improve OpenRegSource to better facilitate the advancement of their work.

Objectives/Goals: The informed consent (IC) process is similar between clinical trials and expanded access (EA), which allows clinical use of investigational products outside studies. Physicians face unique barriers to IC in clinical environments. This project assesses IC documentation, identifies potential barriers, and evaluates efforts to improve compliance. Methods/Study Population: This is a continuous quality improvement project. To assess the compliance of IC processes for EA patients, informed consent documents signed by EA patients in 2023 were collected and reviewed against institutional standards. Five components of each form were evaluated, and the number and type of noncompliant documentation were tracked. Five physicians who provided EA treatments in 2023 were interviewed and the transcripts were analyzed to identify barriers to physician’s and teams’ IC processes. Efforts made to address these barriers and improve the compliance of informed consent documentation are being tracked and trends in compliance are being evaluated. Results/Anticipated Results: Sixty seven (67) signed informed consent documents for EA treatments were systematically reviewed and 34% were found to be compliant in all key aspects assessed. Analyses of interview notes, transcripts, and memos identified barriers to informed consent processes for expanded access treatments, including the infrequent or irregular occurrence of EA treatments making it difficult for care teams to develop and maintain their understanding of IC process and resources. Efforts made to improve compliance by pre-populating available information into informed consent documentation and removing unnecessary boxes in these forms may have driven improvement in compliance with further efforts underway. Discussion/Significance of Impact: This project evaluated the compliance of IC documentation for EA treatments and identified drivers affecting physicians’ IC processes for these patients. Different strategies to improve the compliance of IC documentation were evaluated and potential best practices for EA support were identified.

Objectives/Goals: Diffusion of innovations (DoI) posits that new health-related ideas spread through communities over time and across stages of adoption. We will apply DoI to understand a paradigm shift toward seeing participants as partners in clinical research, specifically through delivery of plain language summaries of results. Methods/Study Population: The return of results in lay language (plain language) to clinical trial participants represents a paradigm shift in the EU and now the USA. We will conduct a systematic review of the implementation of “lay summaries” or “plain language summaries” in different jurisdictions to understand current regulatory influence. We will then review PLS samples and published studies to determine the rate of adoption by industry and non-pharmaceutical company sponsors. Using the DoI framework, groups will be placed in an adopter category. Finally, we will employ an implementation science approach to understand the diffusion process and the translation to participants, laying the groundwork for a culture of change in medical product development. Results/Anticipated Results: Our search on PubMed using key terms “Diffusion of Innovation” and “Plain Language Summary” did not produce any relevant results in the context of clinical trials in the USA, which illustrates a gap in the literature and application of this theory in this context. In the future analyses, we will examine factors influencing the adoption stage and outcomes, such as regulatory action, what best practices have been defined/implemented (if any), culture shifts in the context of clinical research, health communications, and inclusion of patient voices in clinical research. Our analysis will include a network analysis to evaluate characteristics that influence adoption of PLS in clinical research. We hope to identify who is at the forefront of innovation and why. Discussion/Significance of Impact: Novel application of DoI theory will help lay the groundwork for a culture of change in patient-focused drug development, specifically for the dissemination of results to patients. In future studies, we plan to develop a tailored framework for the inclusion of PLS as part of a paradigm shift in the patient-focused drug development process.

Objectives/Goals: This literature review examines the current landscapes of plain language summaries (PLS), which are used to make research accessible to nonexpert audiences. It aims to identify gaps in their implementation by focusing on challenges related to consistency, accessibility, and quality across fields. Methods/Study Population: A systematic search was conducted using databases such as PubMed and Google Scholar, employing key search terms like “plain language summaries,” “scientific communication,” “health literacy,” “patient education,” “knowledge translation,” “accessibility in research,” “public engagement,” “lay-person,” and “lay summaries.” Literature from multiple sources (pharmaceutical companies/industry, nonprofit organizations, private–public partnerships, and government) was compared to assess the gaps in current PLS best practices. Results/Anticipated Results: Search results yielded 95 articles. Of those, 37 articles fit the criteria, highlighting critical gaps in PLS implementation for clinical research. Preliminary findings suggest a lack of standards and guidelines, as well as a need for more research on the effectiveness of PLS for improving knowledge transfer and patient engagement. Key limitations were identified for investigator-initiated trials (IITs). A best practice table, comparing recommendations from each group of sources, was developed with suggestions for writing effective PLS. While there is consensus on some principles (i.e., importance of simplicity), differences emerge regarding optimal length and the use of layperson glossaries and graphics. The table aims to serve as a guide for creating effective and standardized PLS across fields. Discussion/Significance of Impact: There are limited PLS best practice resources tailored for IITs. These findings could lead to more practical tools and a streamlined approach to enhance communication strategies for lay audiences. This would benefit trial participants and community members who rely on this information and bridge the gap between scientific communities and the public.

Objectives/Goals: How do we care for a patient whose mental health is deteriorated such that their decision-making capacity may be compromised? The high-potency opioid crisis in Ontario demands that we provide effective care for the affected population. We must also avoid patients having a subjective experience of coercion and must protect their human rights and dignity. Methods/Study Population: Ontario’s legislation governing mental health care will be explored: the Ontario Mental Health, Healthcare Consent, and Substitute Decisions Acts. We will identify best practices/learning across locales. Patients who have been involuntarily treated/confined will be welcomed to voice what the law should contain. International strategies for: coercion reduction practices, advanced care directives, less prohibitionist care culture, and supports for social determinants of health (SDH) may also help Ontarians. Patients, family members, law enforcement, judiciary, community agencies, and healthcare professionals will be invited to contribute via focus groups to drafted mental health care legislative improvements. Thus, we ensure law enforces patient-defined quality care and practical workflows. Results/Anticipated Results: We hope to emerge from our focus group consultation with draft legislative and procedural edits for Ontario’s mental healthcare laws to ensure that the laws protect human rights and that the laws reflect patient-defined needs. We must ensure controls are in place to de-risk power imbalances and limit the incidence of potential procedural misuse. We intend to design legislated procedures to ensure that people don’t get inappropriately involuntarily confined/treated. We will incorporate the perspectives and lived experiences of patients who have experienced involuntary treatment and/or involuntary medical confinement (locally in a focus group(s)) and internationally (in literature) to inform this legislative development. Discussion/Significance of Impact: We will learn from engaged stakeholders about how to shape Ontario’s legislation to support quality mental health care. We hope to identify and draft legislation improvements that voice what patients and their families’ value, drafts informed by evidence-based best practices and informed innovation. Via inclusion, we create a policy that serves.

Objectives/Goals: To identify the most impactful regulations regarding the approval and marketing of TMs in the U.S., E.U., Japan, Australia, China, and India enacted between the years 2000 and 2022. To explore TM-related regulations in new countries, Japan and Australia, for their novel regulatory approaches in intersecting Western and Eastern medical practices. Methods/Study Population: International regulatory bodies included in this study were chosen based on the country’s long history with TM and/or the existence of review processes specific to TM. TM-related regulatory changes that were enacted between the years 2000 and 2022 were identified and categorized into special departments, changes in clinical trials, or specialized tracks. The impact of these TM policies was measured via the number of TM-related INDs, approved applications, marketed drugs, and rejected applications per decade since 2000. This data was then organized alongside policies to draw conclusions about the influence of these regulatory changes. All data was collected using official government websites and journals published by independent, external research institutions accessed via USC’s library services. Results/Anticipated Results: Previous research revealed each country made efforts to integrate TMs into existing drug practices, such as clinical trials and safety requirements, although the extent and methods for the integration differed. Countries with a longer history with TMs are predicted to have regulatory systems that are more accommodating to the unconventional nature of TMs, making the approval and marketing of TMs much easier in these countries. As TM-related policies are more refined and increase in number in a given country, the number of TM-related applications and TMs marketed as legitimate, prescribable medications will also increase. Discussion/Significance of Impact: Timelines and charts displaying the impact of new TM-related regulatory changes will help identify a successful model for increasing TM IND submissions, approvals, and marketed TM drugs.

Objectives/Goals: The purpose of this pilot study is to conduct a survey interview to understand the knowledge and attitudes of people experiencing homelessness (PEH) toward clinical trial participation, provide insights for future engagement strategies, and begin bridging the gap between clinical researchers and this marginalized group. Methods/Study Population: A 14-question survey, developed in collaboration with the street medicine (SM) team at the University of Southern California and other key stakeholders in PEH research, was administered in a survey–interview style to PEH in SM’s East Side Los Angeles area of operations. The questions were designed to assess PEH’s knowledge and attitudes toward the significance of clinical research and their potential participation. No identifying information was collected. To ensure diversity in responses, the surveys were conducted in different SM healthcare providers’ areas of operations. The responses were then analyzed both quantitatively and qualitatively, taking into account the broader perspectives that PEH may have toward clinical trial research. Results/Anticipated Results: A total of 9 PEH were surveyed. When asked to share their thoughts on “clinical trials” (CTs), most described the need to travel on-site to a practitioner to be studied/tested. They indicated that they knew what CTs were and that the FDA’s official definition was easy to understand. Only one respondent reported being part of a diagnostic trial, and one declined to answer. Four respondents indicated a willingness to participate in a CT. Four answered “maybe” and one answered “no.” Of note, most believed that CTs have a positive impact, and only one responded that they think researchers do not maximize health benefits and minimize risk. Outside of the allowed answer choices, respondents also shared that there should be payment for participation in a CT, even if they don’t expect any. Discussion/Significance of Impact: The survey results could significantly influence the future of clinical research, guiding it to be better tailored to PEH’s unique circumstances, thereby potentially improving their participation rates. A key objective for the future will be to increase the sample size of the survey to improve the applicability and impact of the results.

Objectives/Goals: The World Trade Center (WTC) Health Program (Program), a limited federal healthcare program for eligible people exposed to the terrorist attacks on September 11, 2001, expanded telemedicine services during the COVID-19 pandemic. We analyzed service use trends from 2020–2021 to describe how the program implemented telemedicine services. Methods/Study Population: We estimated use rates of telemedicine-eligible services and telemedicine services by all included program members and by subgroups of members defined by member type (responder or survivor) and selected characteristics for the study period 2020–2021. We described the use trends of total telemedicine-eligible visits, telemedicine visits, and in-person visits, respectively, by quarter. We calculated the quarterly rates of telemedicine use per 1000 living members. We used a multivariable logistic regression to examine associations between member characteristics and telemedicine use rates. Results/Anticipated Results: About 75% of telemedicine visits were related to mental health services. In the second quarter of 2020 (April–June), telemedicine use rate (367 visits/1000 members) increased, exceeding in-person service rate (152 visits/1000 members) by 1.4 fold. Telemedicine use rate decreased gradually in the rest of the study period but still represented 38% of total visits by the end of 2021. Regression models showed differences in telemedicine use rates by member type and by demographic characteristics. Survivor members (vs. responder members), those self-identified as non-Hispanic Other races (vs. non-Hispanic White), those with preferred non-English language (vs. preferred English), and those not living in the New York metropolitan area (vs. living in the New York metropolitan area) were less likely to use telemedicine. Discussion/Significance of Impact: The expansion of telemedicine service provided members uninterrupted access to necessary health services during the COVID-19 pandemic. It underscored the importance of extensive partner collaboration, the capacity to rapidly develop necessary technical guidance, and the flexibility to timely address frequent regulatory guidance updates.

Objectives/Goals: MyCTSC harmonizes data from many sources into one database for evaluation, marketing, and CTSC member management to address current disparate collection and siloed use of data. It simplifies report creation with real-time dashboards so administrators and leadership can view progress quickly and plan for improvements based on real-time data. Methods/Study Population: MyCTSC is built using open-source software like Python, Django, MariaDB, Bootstrap, and Chart.js, and integrates data from sources such as systems for consult requests, pilot/voucher applications, and REDCap surveys. Each data source is imported into the warehouse either automatically via API, if available, or via manual file upload. De-duplication and other data cleaning are performed as well. Customized, real-time dashboards are developed based on the needs of administrators and leadership. While MyCTSC does not have a study population, it does have the stakeholders mentioned above as well as leadership. The development timeline spans three years: initial development and data warehouse population in Year 1, data cleaning and dashboard creation in Year 2, and full rollout to all CTSC members in Year 3. Results/Anticipated Results: MyCTSC aims to create a seamless data and member management system to resolve issues stemming from multiple data sources. Demographic challenges are addressed by implementing data cleaning and consolidating duplicate identities into a single profile. The initiative will enhance stakeholder buy-in by presenting evaluation use cases that show the impacts of CTSC resources. For example, workforce development needs will be met through surveys and integration of a course catalog. MyCTSC will also facilitate targeted resource and event advertising, and support investigator outreach and collaboration by utilizing dashboards and reports. Furthermore, it will serve as the consolidated data source for all CTSC modules, promoting greater interaction and collaboration across administration and modules. Discussion/Significance of Impact: MyCTSC integrates multiple sources, consolidates identities, and simplifies reporting for outreach and collaboration. It enhances interaction with researchers and community members, advancing translational science by linking projects and publications. MyCTSC, built with open-source software, can be made available to other CTSA hubs.

Objectives/Goals: Our goal is to develop a CRM platform to streamline support for investigators, optimize resource use, and enhance service delivery within a CTSA institution. This platform will measure outcomes, improve transparency, and ensure compliance, creating an efficient, supportive research environment. Methods/Study Population: Beginning with the design concepts and collecting technical requirements, ensuring alignment with the needs of investigators, administrators, and service units. Apply project management methodologies to iteratively design, prototype, and test features. Focus on user-centric interfaces and seamless integration with institutional systems. Incorporate stringent data security protocols in compliance with regulatory standards. Conduct pilot studies to refine functionalities and gather constructive feedback. Facilitate extensive user training programs and offer continuous support. Regularly monitor performance metrics, iterating based on empirical data and user feedback to ensure continuous enhancement and adherence to institutional objectives. Results/Anticipated Results: YCCI successfully designed, developed, and implemented a CRM platform for managing the intake, navigation, consultation, service delivery, and outcomes tracking of the clinical and translational science activities that are supported by and beyond the CTSA-supported infrastructure. The CRM platform has been live in production since roughly July 1, 2024, and YCCI is excited to share data, results, and outcomes with the ACTS community. Discussion/Significance of Impact: YCCI’s CRM platform advances the CTS mission by streamlining PI support, enhancing resource utilization, and fostering inter-team collaboration within the research ops and administration teams. Measuring outcomes and service efficiency enables data-driven decisions, ensuring continuous improvement, and impactful translational science.

Objectives/Goals: To explore how generative AI and chatbot technologies can transform clinical research administration by improving operational efficiency, reducing administrative burden, and thereby enhancing overall productivity and accuracy in clinical research environments. Methods/Study Population: This explores AI’s application in enhancing clinical research administration. We specifically address AI’s role in QCT/MCA activities, charge master data cleaning, and generating IRB consent forms from award documents. AI algorithms optimize charge master data for accuracy and compliance. Generative AI models are employed to produce IRB consent forms efficiently, incorporating key grant documents. AI also conducts thematic analyses of historical CTSA aims to identify trends and recurring themes. Furthermore, AI-assisted tools enhance study design through innovative approaches to hypothesis generation, sample size calculation, and protocol development. Integrating these AI methods aims to significantly improve efficiency, accuracy, and overall quality in clinical research administration. Results/Anticipated Results: Incorporating AI into clinical research administration will yield improvements in efficiency and accuracy. AI-driven QCT/MCA steps are expected to reduce human error and enhance data integrity. Chargemaster data cleaning via AI prompts will likely result in optimized, error-free data, ensuring compliance with regulations. The use of genAI for creating IRB consent forms from grant documents should significantly streamline the IRB approval process, reducing preparation time and administrative burdens. Thematic analysis of CTSA aims by AI will provide deep insights into historical trends and recurring themes, aiding in strategic planning. AI-assisted study design tools are anticipated to optimize sample estimation, protocol development, and advance the quality of clinical research administration. Discussion/Significance of Impact: The significance lies in enhancing efficiency, accuracy, and quality in clinical research administration. By streamlining processes, reducing errors, and providing strategic insights, AI supports the CTSA mission to accelerate translational research, thus improving public health outcomes and scientific innovation.

Objectives/Goals: Digital recruitment can improve participant engagement in medical research, but its potential to introduce demographic and socioeconomic biases is unclear. This study investigates pathways participants took during a digital recruitment workflow in neurology, examining potential associations with socioeconomic and demographic factors. Methods/Study Population: As part of an ongoing study aiming to remotely capture speech from patients with neurologic disease, most participants seen in neurology on our campus are invited to complete a self-administered speech examination. We exported participant data from Epic (semi-automated identification and invitation), Qualtrics (eligibility screening), the participant tracking database (consent), and the recording platform (completion) for March to July 2024. Data visualization was performed using a Sankey diagram. Socioeconomic status was assessed using the housing-based socioeconomic status (HOUSES) index and area deprivation index (ADI) national rank. Kruskal–Wallis and Wilcoxon rank-sum tests were used to compare the median age, socioeconomic indices, and time taken to reach different steps of the study. Results/Anticipated Results: Of the 5846 invited participants, 57% were from urban areas, 23% from rural areas, and 20% from urban clusters. Most did not read/respond (2739) or declined (1749) the initial invitation via Epic. Of the 1358 interested participants, 415 completed the study. Participants from urban areas completed enrollment steps faster than those from rural areas and urban clusters, though the variance was large (42.6 ± 41.4 days vs. 50.6 ± 42.2 days and 50 ± 43.9 days, respectively; p  =  0.030). Female participants took longer to complete enrollment than males (48.7 ± 44 days vs. 40.5 ± 38.8 days; p  =  0.026). Participants who successfully finished the study had significantly lower ADI national ranks compared to other common pathways (40.6 ± 19; p  =  0.0021). No associations were found with the HOUSES indices. Discussion/Significance of Impact: Our findings support differences in participant engagement, with urban participants and males more likely to complete enrollment steps. Those who finished the study were less disadvantaged suggesting potential bias in digital recruitment. These findings can inform strategies to improve digital recruitment in neurology research.

Objectives/Goals: Conduct an evaluation of the Clinical Research Support Center (CRSC) model using a structured methodology, leverage insights to drive continuous improvement and evolution, and broadly disseminate outcomes to promote knowledge sharing and best practices for similar translational science initiatives. Methods/Study Population: We will utilize a structured case study approach, including adapting a translational science case study evaluation approach to assess impact as well as support practices, barriers, and facilitators that influence research translation. We will collect data from diverse sources. Primary data will come from structured interviews with stakeholders and a survey of a random sample of faculty and research staff. Secondary data includes grant applications, reports, and publications; public stories/media related to research supported by CRSC; scientific publications; and organizational documents. Results/Anticipated Results: The case study will identify the CRSC model’s impact on the research enterprise. Findings will articulate the specific strategies and practices the CRSC implemented to support clinical research; key factors, people, and resources that helped develop, improve, and promote CRSC services; significant milestones in evolution of the CRSC; and specific ways in which support services impact clinical research infrastructure and outcomes. The findings will highlight both strengths and areas for improvement. Early results show historical challenges with operational silos and resource limitations. Findings suggest CRSC facilitators include a team science approach with institutional support. Discussion/Significance of Impact: This case study will provide insights related to benefits, challenges, and facilitators of a translational science support model. Insights will guide the CRSC’s evolution and be broadly disseminated to promote knowledge sharing and best practices for future translational science applications.

Objectives/Goals: This continuous quality improvement project focuses on the efficiency and effectiveness of social media campaigns for clinical trials and other health research. We analyzed data from 160 studies that recruited via social media campaigns on Meta and used the results to make improvements to MICHR’s Participant Recruitment social media campaigns. Methods/Study Population: Data on 440 ad buys purchased for Meta advertising campaigns designed for 160 studies were collected from U-M’s Research Data Warehouse, Meta, and other administrative sources. MICHR’s participant recruitment team systematically reviewed these data and rated the relevance and effectiveness of the recruitment strategies for each study. Stepwise linear regressions were used to test predictors of the efficiency and effectiveness of social media campaigns on Meta, as measured by the 1) total reach, 2) total clicks, 3) the “click-through rate,” and 4) cost per “click” of the campaign over time. Differences between the impact of campaigns for clinical trials and other clinical and translational research were found. Improvement initiatives informed by these results are underway and their impact is being evaluated. Results/Anticipated Results: 64 clinical trials and 94 non-trials were identified, with an average of $1,635 spent on social media campaigns for trials and $950 spent on non-trials. Across all social media campaigns, an average of 121,500 people were reached at a total cost of $1,220 per campaign, returning 4,288 clicks (4% click through rate) at $0.38 per click. The campaigns for trials reached more people than non-trials (152,998 vs. 101,261) and they attracted a larger number of clicks (6090 vs. 3106). The resulting average click-through rate was higher for clinical trials (4.9% vs. 3.7%), and the cost per click was lower ($0.35 vs. $0.39). Campaigns for clinical trials cost significantly more (Mean  =  $1,635, SD  =  $1,473, p  =  .020) but returned more clicks (Mean  =  6,090, SD  =  5,105, p  =  .007), and higher click-through rates (Mean  =  4.9%, SD  =  2.2%, p  =  .017). Discussion/Significance of Impact: There is great variation in the efficiency and effectiveness of social media advertising campaigns for recruitment into clinical trials and other clinical and translational studies. While the size and cost of these campaigns were found to be higher for clinical trials than for non-trials, the effectiveness of trials’ campaigns can also be greater.

Objectives/Goals: Clinical and Translational Science Award hubs will be the primary investors in advancing translational science until academic reward structures and funding agencies incentivize these efforts. As such, hubs will benefit from systematic methods to strategically identify and efficiently solve challenges in the translational process. Methods/Study Population: Translational science (TS) problems are abundant, complex and typically reside within systems of interconnected processes and people. These characteristics are informing efforts at the Michigan Institute for Clinical & Health Research (MICHR) to create a framework that guides how we select the right translational science problems to invest in solving and how we solve these problems in user-centric, efficient, and effective ways. Our framework leverages methods from the fields of design and systems thinking. Design thinking is a human-centered approach to problem solving and innovation that is ideal for tackling ill-defined and complex problems. Systems thinking methods help us situate and analyze problems within broader dynamics, structures, and perspectives, ultimately informing key levers for change. Results/Anticipated Results: Applying design and systems methods, we created an eight-step TS framework that centers on the diverse perspectives of those experiencing a TS problem and those implementing solutions. The first four steps guide in defining the TS problem within its context, understanding why previous solutions have not worked, and determining the value and generalizable knowledge that a solution would create. The last four steps are solutions-focused, with iterative brainstorming, testing, and refining of potential solutions before they are implemented locally and disseminated widely. Each step is underpinned by guiding questions, methods, outputs, and metrics to ensure a scientifically rigorous approach to defining, prioritizing, and solving TS problems. We are currently prototyping the framework with various case studies. Discussion/Significance of Impact: A framework that guides strategic investment in TS should ensure resources are allocated to the most well-defined and pressing problems that are important to the community and should speed up the process of creating solutions. Engaging myriad viewpoints leads to more viable solutions that foster a commitment to real change within the research ecosystem.