OBJECTIVES/SPECIFIC AIMS: Because clinical trial results are instrumental in the approval of a new drug or changes to the practice of medicine, ensuring the accuracy and validity of collected data is critical in the clinical trial process. This function, routinely carried out by clinical trial monitors in industry-sponsored trials, is often lacking in investigator-initiated trials (IITs) conducted in academia. To address this challenge, we have developed a self-study module that can be used to cross-train academic researchers in essential concepts and practical approaches to monitoring. Furthermore, we are applying a framework drawn from implementation science in the development and launch of this initiative. This framework, as used in other educational programs, is employed here to close the gap between initiative and practice, thereby effectively disseminating this training would improve the quality of clinical trials in academia. METHODS/STUDY POPULATION: This research project applied exploration, installation and implementation stages of the implementation science process by 1) exploring the need for a new initiative, 2) disseminating results, 3) engaging stakeholders, 4) creating standard operating procedures (SOPs) for installation and implementation, 5) studying user satisfaction and effectiveness, 6) addressing feedback and 7) conducting implementation. RESULTS/ANTICIPATED RESULTS: From literature review and internet searches we determined that although numerous GCP training resources exist, most are too broad and lack the practical approaches to meet the complex requirements of monitoring. Moreover, most of the offerings identified are costly or inaccessible. With only about 65% of IITs reported as being monitored (Figures 1 and 2), it appears that there is a clear need for training tools that are easily available to a broader audience. And because monitoring skills are substantially different from those associated with research coordination, it is not surprising that research professionals believed that they would need additional training to become proficient. To address this need, we began developing a monitoring module. We engaged key stakeholders from academia and industry to gain insights into their needs. The results indicated that although our training module was effective, supplementary information on the fundamentals of clinical trials should be included for those new to the field. After incorporating suggested changes and completing the module, we conducted user testing to determine if our module is ready to be broadly disseminated (Figures 3 and 4). Following positive feedback from the group, we are currently in the process of disseminating our module and studying its impact. DISCUSSION/SIGNIFICANCE OF IMPACT: IITs are instrumental in translating academic research into product development. Deficiencies in the quality control of these trials can lead to inadequacies in data accuracy and validity that could lead to significant delays in bringing innovative therapies to patients. Recent NIH policies require data and safety monitoring for all of the trials it supports. The latest addendum to ICH GCP, E6(R2), discusses a need for quality management across the clinical trial lifecycle. As we continue to disseminate and share information during the development of our self-study monitoring module, we are engaging key stakeholders from academia, government, and private institutions to understand and address quality challenges in conducting clinical trials. Finally, this research informs dissemination and implementation research, specifically for creating training for academic research professionals.

OBJECTIVES/GOALS: Improving physical activity of African American women experiencing disproportionate health risks from sedentarism, educational and socio-environmental barriers. BeFit: Building Empowerment through Fitness is based on “What I Learned At Home” project, run by Women Under Construction Network, for residents of the Birmingham Housing Authority. METHODS/STUDY POPULATION: A qualitative study design to understand unique cultural context and challenges faced by African American women residing in the Birmingham Housing Authority, regarding physical activity engagement, including sedentarism. A needs assessment approach will help determine barriers, support systems, and social networks. Semi-structured, pre, mid, and post program focus groups will identify challenges and opportunities for health, such as diet and exercise, and will be analyzed by hand with a thematic analysis. The project framework uses exercise and home repair tools with a life-building/life repair curriculum to influence health, self-efficacy, and program engagement. The Study enrollment will include 50 women over two cohorts in a 12-week project. RESULTS/ANTICIPATED RESULTS: This research addresses the urgent health needs of African American women in low-income communities. These women face heightened health risks due to sedentary lifestyles, educational gaps, and socio-environmental barriers. This project targets the pronounced prevalence of allostatic burden in this population by applying a culturally sensitive, bottom-up approach. Our goal of incorporating healthy lifestyles to improve health in at-risk women and their families requires multiple projects. This project is a necessary first step in engaging with a community to identify local environmental circumstances and barriers to increasing the relevance of physical activity within the home. These barriers can then be addressed by adapting an exercise promotion program to the needs of this community. DISCUSSION/SIGNIFICANCE: Black women in under-resourced communities are more likely to be sedentary and have poor health. Exercise programs can be a powerful tool to address disparities and help prioritize health. The circumstances of women in public housing in Birmingham, AL, need community partners to adapt exercise engagement programs to meet environmental challenges.

OBJECTIVES/GOALS: The goal of this study was to perform a comparative, multi-reader, retrospective clinical evaluation of prostate multiparametric MRI (mpMRI) at 3 Tesla (3T) vs. 7 Tesla (7T) primarily in terms of prostate cancer localization. Subjective measures of image quality and artifacts were also evaluated. METHODS/STUDY POPULATION: Nineteen subjects were imaged at 3T and 7T between March 2016 and October 2018 under IRB-approved protocols. Four radiologists retrospectively and independently reviewed the data, and completed a two-part assessment for each dataset. First, readers assessed likelihood of cancer using Prostate Imaging Reporting & Data System (PI-RADS) guidelines. Accuracy of cancer detection was compared to findings from prostate biopsy. The numbers of correctly or incorrectly classified sextants were summed across all four readers, then used to summarize detection performance. Second, readers assigned a score on a five-point Likert scale to multiple image quality characteristics for the 3T and 7T datasets. RESULTS/ANTICIPATED RESULTS: Sensitivity and specificity of 3T and 7T datasets for sextant-wise cancer detection were compared by paired two-tailed t-tests. Readers identified more sextants harboring cancer with the 3T datasets while false-positive rates were similar, resulting in significantly higher sensitivity at 3T with no significant differences in specificity. Likert scores for image quality characteristics for 3T and 7T datasets were compared by applying paired two-tailed t-tests to mean scores of the four radiologists for each dataset. Readers generally preferred the 3T datasets, in particular for staging and assessment of extraprostatic extension as well as overall quality of the contrast-enhanced data. DISCUSSION/SIGNIFICANCE OF IMPACT: Readers agreed 7T prostate mpMRI produced images with more anatomic detail, though with equivocal clinical relevance and more pronounced artifacts. Reader unfamiliarity with 7T images is a major extenuating factor. Forthcoming technological developments are anticipated to improve upon the results.

Translation of research discoveries into health impact can take many years, creating delays in improving clinical outcomes. One approach to promoting timely translation is to examine successful cases in order to understand facilitators and strategies for overcoming barriers. We examined the development of evidence-based management for neonatal abstinence syndrome (NAS) at one academic medical center, with a primary focus on pharmacologic treatment. Despite a substantial increase in NAS case incidence starting in the early 2000s, significant sociocultural, policy, and regulatory barriers limited collaborative NAS research. Facilitators for translation encompassed: 1) pursuing research of societal interest, 2) building an effective interdisciplinary team, 3) intentionally linking clinical, research, and advocacy efforts, 4) broad stakeholder engagement across clinical, policy, and research arenas, and 5) leveraging local resources. Challenges included lack of commercially available U.S. Food and Drug Administration approved neonatal drug formulations, legal and regulatory barriers related to off-label and illicit use of opioids, recruitment for a treatment associated with drug withdrawal syndromes, misalignment of research design needs with real-world scenarios, and episodic funding. Benefits of successful translation included improvements in clinical care, reduced healthcare costs related to NAS, and enhanced legislative, policy, and research strategies to support broader neonatal investigations.

ABSTRACT IMPACT: This study will provide important insight about effective team formation from coming up with an idea to successfully implementing that idea, as well as will highlight the implementation, evolution, and future directions of a team science initiatives. OBJECTIVES/GOALS: The goal of this study is to describe the feasibility of initiating an ideation forum to catalyze team formation, explore the process by which themes and teams are selected to participate in the forum setting, and assess the progress of participating teams post-forum through internal and external funding and other synergistic research activities. METHODS/STUDY POPULATION: Three ideation forums took place between 2018-2019 at Rutgers University, with a defined process and collection of data. The method of intervention to trigger team science, specifically the methodology employed to identify teams and produce new collaborative ideas, will first be described to show the feasibility of such an event to encourage team formation. In post-hoc analysis, we compare various success matrices of participating teams received seed funding versus teams that didn’t receive any funding to assess the progress of teams in the research ideation forum incubation process. RESULTS/ANTICIPATED RESULTS: Triggering team science through ideation forums is feasible and, in fact, quite productive to creating a durable response in formed teams showing continued productivity in publications, fundraising, and other academic metrics. DISCUSSION/SIGNIFICANCE OF FINDINGS: Our case review can illuminate how academic institutions can support team science research through ideation forums. In addition, this study lays an initial foundation for improvements in ideation forum creation and new metrics that can be shared broadly to compare across other institutions.

OBJECTIVES/GOALS: In spite of significant growth in undergraduate research, there is little accessible RCR training material targeting this group. The goal of this project was to develop level appropriate RCR materials and test them for effectiveness of teaching basic knowledge of RCR. It was developed cognizant of the type of learning preferred by this group. METHODS/STUDY POPULATION: Todays undergraduate students are digital natives accustomed to using on-line resources for learning and value the ability to work independently. An asynchronous, online series of eight RCR modules were developed using PowerPoint. Audio instruction was overlaid over the presentations and uploaded to YouTube. Each module includes quiz at the end that must be completed with a 90% score in order to continue and students can retake each quiz until correct. Case studies, a plagiarism game, and additional resources such as infographics created by the Office of Research Integrity were included. 275 first year undergraduates completed the pilot and the on-line retrospective pre-post assessment that included 28 Likert scale items and two open-ended questions that were analyzed with RapidMiner. RESULTS/ANTICIPATED RESULTS: Participants rated their ability prior to and after the course to recognize the roles/responsibilities of a mentor, maintain and organize data records, recognize what constitutes research misconduct and multiple types of plagiarism, define ethics of authorship and the types of peer review, recognize responsible handling of human and animal subjects and to define collaborative research. Responses were analyzed using t-Tests and all items showed a significant increase. Students reported between a 28% and 50% increase in knowledge in each topic and gains in understanding where to report RCR violations. Text analysis using RapidMiner provided developers with suggestions on how to enhance the project. Students reported finding the course concise and easy to understand and valued the included case studies. DISCUSSION/SIGNIFICANCE: This study demonstrated that RCR materials developed specifically for todays undergraduate students, presented an easily accessible format, effectively conveys the basics of RCR. The on-line, asynchronous format made it accessible to those for whom in person course is not possible. This model fills the gap in RCR training for early researchers.

Chronic non-cancer pain (CNCP) involves one-third of the US population, and prescription opioids contribute to the opioid epidemic. The Centers for Disease Control and Prevention emphasizes maximizing non-opioid treatment, but many rural populations cannot access alternative therapies. Clinical and Translational Science Award hubs across four rural states performed a multi-site, single-arm intervention feasibility study testing methods and procedures of implementing a behavioral intervention, acceptance and commitment therapy, in primary care CNCP patients on chronic opioids. Using the CONSORT extension for feasibility studies, we describe lessons learned in recruiting/retaining participants, intervention implementation, data measurement, and multi-site procedures. Results inform a future definitive trial and potentially others conducting rural trials.

Clinical and translational research relies on a well-trained workforce, but mentorship programs designed expressly for this workforce are lacking. This paper presents the development of a mentoring program for research staff and identifies key programmatic outcomes. Research staff participating in this program were matched with a senior mentor. Focus groups were conducted to identify key program outcomes. Surveys were administered throughout the program period to assess participants’ experience, gains in skill, and subsequent careers. Analysis of the resultant qualitative and quantitative data are used to characterize the implementation and impact of the program. A total of 47 mentees and 30 mentors participated in program between 2018 and 2023. A comprehensive logic model of short-, intermediate- and long-term outcomes was developed. Participants reported positive valuations of every programmatic outcome assessed including their program experience, learning and research careers. The pool of available mentors also grew as new mentors were successfully recruited for each cohort. This mentorship program developed and implemented by senior research staff successfully provided junior research staff with professional development support, mentorship, and professional development opportunities. Junior and senior health research staff built mentoring relationships that advanced their clinical and translational research careers.

OBJECTIVES/GOALS: Using a community-based participatory research (CBPR) approach, the All of Us (AoU) Wisconsin Froedtert & the Medical College of Wisconsin (MCW) site aimed to improve public understanding of science by creating a Special Interest Group (SIG) of community members and scientists and driving healthcare research relevant to Southeastern Wisconsin. METHODS/STUDY POPULATION: We recruited community members from the AoU advisory boards and scientists from Froedtert & MCW. These SIG participants will converge on a hypothesis that aligns with community priorities and conduct research using the national AoU database, which combines EHR, survey, and whole genome sequencing data. A year of monthly SIG meetings from 2022-2023 will serve as focus group sessions that will be recorded and transcribed. In addition to descriptive statistics on participant demographics and affiliations, we plan to qualitatively characterize transcripts, field notes, and feedback, such as participation satisfaction or reflection on self- and group-driven impact. We will publish alongside all SIG members on both the research outcomes and the SIG-driven process to inform future similar endeavors. RESULTS/ANTICIPATED RESULTS: To date, we held three SIG meetings, which together formed the discover and define stages in the human-centered design framework. We narrowed down SIG membership to 15 consistent participants. Our coalition building conversations emphasized group priorities and future payoffs for independent research and community partnerships. Realizing a crucial need for bioinformaticians to prosecute SIG-driven research questions, we created a data subgroup of trainees and scientists to familiarize themselves with the AoU Researcher Workbench. Through shared decision making during this community engaged process, we are converging on a research direction centering on specific diseases or adverse outcomes with relevance to Southeastern Wisconsin communities and with implications for personalized medicine. DISCUSSION/SIGNIFICANCE: SIG scientists will learn about CBPR and access the AoU database. SIG community members will better understand the research process and share their lessons with local communities. The AoU Wisconsin research team will disseminate findings on the collective research process and empower scientist use of this nationally curated AoU database.

OBJECTIVES/GOALS: The HIV acquisition rate is higher for cisgender black women in the United States. This population has a much lower use of FDA-approved pre-exposure prophylaxis drug (PrEP) for HIV prevention. This systematic literature review examines factors that hinder PrEP use among cisgender black women. METHODS/STUDY POPULATION: PubMed, CINAHL, and Cochrane were used to conduct a systematic literature search. Inclusion and exclusion criteria were predetermined to narrow down the search and to identify the appropriate studies. The retrieved literature was exported to EndNote for deduplication. The literature was then uploaded into Rayyan for title and abstract screening. The two collaborators were blinded to limit bias. Literature characterized as conflict was resolved by an independent, third collaborator. Full-text screening of the selected studies was done and a PRISMA flow diagram was developed for identification, screening, eligibility, and to detail included literature. RESULTS/ANTICIPATED RESULTS: 185 articles were obtained from the systematic literature search. 172 were excluded and 13 full-text articles were accessed for eligibility. One was removed. 12 studies involving 974 study participants met inclusion criteria for analysis. Despite the disproportionally high risk of HIV infection, black women only represented 29% of the study participants. Top three barriers to low PrEP use were stigma, socio-economic factors, and personal factors. Stigma included concerns about HIV and sexuality. Socio economic barriers were related to homelessness and low income. Personal factors included substance abuse, incarceration, and commercial sex work. The data confirms that these risk factors were not always rigid but changed based on patient characteristics and external factors. DISCUSSION/SIGNIFICANCE: The study outcomes confirmed a multitude of risk factors that serve as impediments in the use of PrEP among cisgender black women. When these risk factors are identified and addressed, the decision to use PrEP among cisgender black women may increase, therefore this warrants further investigation.

In a prospective, remote natural history study of 277 individuals with (60) and genetically at risk for (217) Parkinson’s disease (PD), we examined interest in the return of individual research results (IRRs) and compared characteristics of those who opted for versus against the return of IRRs. Most (n = 180, 65%) requested sharing of IRRs with either a primary care provider, neurologist, or themselves. Among individuals without PD, those who requested sharing of IRRs with a clinician reported more motor symptoms than those who did not request any sharing (mean (SD) 2.2 (4.0) versus 0.7 (1.5)). Participant interest in the return of IRRs is strong.

The rate at which the coronavirus disease (COVID-19) spread required a rapid response across many, if not all, industries. Academic medical centers had to rapidly evaluate, prioritize, and coordinate the multiple requests for clinical trial participation. This involved redirecting resources and developing a collaborative system for assessment, decision making, and implementation. Our institution formed a team with diverse representation from multiple stakeholders to review and prioritize all research protocols related to COVID-19. To accomplish this, a prioritization matrix was developed to help determine the order in which the protocols should be placed for consideration by the treating clinician. The purpose of the team was to review the COVID-19 clinical trials in the pipeline, prioritize those trials that best met the needs of our patients, oversee training and resource needs, and lead the formulation of procedures for integration with clinical care. Resources from the Clinical Research Unit were then allocated to support the swift execution of such studies. This manuscript describes that process, the challenges encountered, and the lessons learned on how to make all clinical trials more successful in a complex and dynamic environment.

OBJECTIVES/GOALS: Particulate matter (PM) and metabolic syndrome (MetSyn) increase risk of World Trade Center-Lung Injury (WTC-LI). Mediterranean-type diets have also been found to improve lung function. Fire Department of New York 1st-responders with a high PM exposure at WTC and MetSyn may have improved lung function after a Mediterranean dietary intervention. METHODS/STUDY POPULATION: Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE) randomized clinical trial (RCT) assessed our hypothesis that a low-calorie Mediterranean (LoCalMed) intervention targeting clinically relevant disease modifiers will improve metabolic risk, subclinical indicators of cardiopulmonary disease, quality of life, and lung function in firefighters with WTC-LI. Primary-outcome targeted a LoCalMed loss of BMI(≥1kg/m2). Secondary-outcomes included lung function, quality of life, and cardiovascular health. Male firefighters with WTC-LI and a BMI>27kg/m2 were randomized to: 1. LoCalMed (n=46); or 2. Usual Care (UC; n=43). Clinicaltrials.gov:NCT03581006. RESULTS/ANTICIPATED RESULTS: LoCalMed’s estimated efficacy on BMI reduction crossed the pre-specified significance boundary on interim analysis compared to UC. In addition, improvements were observed in secondary-outcomes of lung health (FEV1 and FVC), inflammation (WBC), vascular disease (DBP), quality of life (SF-36, health perception) and dietary habits (less cholesterol, carbohydrates, fats, and sweets and increased protein) in the LoCalMed arm. DISCUSSION/SIGNIFICANCE: LoCalMed significantly decreased BMI and alleviated adverse health outcomes in our WTC-exposed first responders. A fully powered RCT is required to determine if this approach is efficacious for the treatment of WTC-associated pulmonary disease, as well as LoCalMed’s generalizability to PM associated disease.

OBJECTIVES/SPECIFIC AIMS: We aim to leverage our analysis of the scientific collaboration network at a research university to design an innovative pilot program and foster scientific productivity. We test the impact of creating a new collaboration in a research community, which decreases the average network distance and accelerates the diffusion of information and expertise among the community’s investigators. METHODS/STUDY POPULATION: We mapped the whole network of co-authorship on publications and co-participation on extramurally awarded grants at the University of Florida (UF) between 2013 and 2015. We used network science methods to identify research communities of investigators who have consistently worked together and/or have other collaborators in common with at least one researcher based in the UF Health Science Center. We selected pairs of communities with (i) similar productivity levels, research interests, and network structures and (ii) no research projects in common. Communities in each pair were randomly assigned to a treatment or control group. In each treatment community, we selected 1 pair of investigators who had not collaborated in the past 3 years and whose connection would maximally reduce average network distance in the community. The pair was provided with an economic incentive to collaborate for the submission of a CTSA pilot proposal. RESULTS/ANTICIPATED RESULTS: We successfully identified 15 pairs of treatment/control communities. In each of 8 treatment communities, a pair of potential collaborators agreed to participate in the intervention. DISCUSSION/SIGNIFICANCE OF IMPACT: Network-informed Clinical Translational Science Awards (CTSA) pilot programs can identify research communities and create innovative collaborations. Statistical experiments can establish the programs’ causal effects on scientific productivity.

OBJECTIVES/GOALS: A clinical research coordinator (CRC) digital badge offers a novel approach to addressing the ongoing shortage of CRCs at academic medical centers. We sought to pilot this low-cost, short-term training digital badge to train entry level CRCs and to attract a diverse pool of individuals. METHODS/STUDY POPULATION: Experienced clinical research professionals outlined competencies needed by study coordinators working in an academic center using a Delphi approach. The competencies aligned with 6 of the 8 domains established by the Joint Taskforce for Clinical Trial Competencies. Five course modules were created in a standardized format consisting of instructional videos, handouts, and a 25-question quiz (passing grade: 90%) which was hosted in the university learning management system. Beta testers were recruited to complete surveys at the conclusion of each module addressing both module performance and content accuracy. An item analysis was performed on the 25-question quiz. RESULTS/ANTICIPATED RESULTS: Nine volunteers were recruited for the pilot. Seven completed the badge. All participants, with years of experience from 0 to over 10 in clinical trials, found the course to be informative. The majority (84%) of responses on course logistics were positive or neutral. The quiz item analysis identified most questions (86%) as either Easy or Neutral, which is ideal for a Level 1 Badge addressing foundational skills. Forty percent of the quiz questions scored high on the Discrimination Index, indicating that the quiz could identify those who performed well and those challenged by the quizzes. One negative comment received stated that course was too intense to be completed in 4 weeks. DISCUSSION/SIGNIFICANCE: The results of this pilot study demonstrated that this badging course offers a low cost, easily accessible option for recruiting and training entry level clinical research professionals. The proof-of-concept study encouraged our initiation of the program and attempt to broaden our reach.