OBJECTIVES/SPECIFIC AIMS: The accurate and efficient serial measurement of patient centered outcomes is a priority in the clinical care of systemic lupus erythematosus (SLE). Patient-Reported Outcomes Measurement Information Systems (PROMIS®) Global Health Short Form (PROMIS10) is a 10-item universal patient reported outcome measure of global physical and mental health with construct validity in SLE. The longitudinal responsiveness (sensitivity to change) of PROMIS10 in SLE patients is unknown. We aimed to evaluate the responsiveness of PROMIS10 in SLE outpatients using patient and physician-derived anchors. METHODS/STUDY POPULATION: Adults meeting SLE classification criteria were recruited from an SLE Center of Excellence. Subjects completed PROMIS10 at two visits a minimum of one month apart. SLE disease activity was measured with a patient global assessment of change, a physician global assessment and the physician-derived SELENA-SLEDAI. Responsiveness over time of PROMIS10 scores was evaluated using known-groups validity. Effect sizes of changes in PROMIS global physical health and global mental health scores from baseline to follow up were compared across groups of patients who differed in their patient global assessment of change, physician global assessment, and SELENA-SLEDAI using Kruskal-Wallis tests. RESULTS/ANTICIPATED RESULTS: A diverse cohort of 228 SLE patients completed baseline surveys (Table 1), with 190 (83%) completing a follow up survey. Using the patient-based anchor, PROMIS10 demonstrated mild to moderate responsiveness to improvement (effect size 0.29) and worsening (effect sizes −0.27 and −0.54) of health status for both global physical health and global mental health (Table 2). Using the physician global assessment and SELENA-SLEDAI as anchors, there were no statistically significant differences in effect sizes across groups. DISCUSSION/SIGNIFICANCE OF IMPACT: PROMIS10 showed responsiveness over time to patient-reported, but not physician-derived changes in lupus health status. These data suggest that PROMIS10 can be used to efficiently measure and monitor important aspects of the patient experience of lupus not captured by physician-derived metrics. Further studies are needed to evaluate the role of PROMIS in optimizing longitudinal disease management in SLE.

OBJECTIVES/SPECIFIC AIMS: Objective: Identify barriers and facilitators of positive patient-provider interactions for AAN patients. METHODS/STUDY POPULATION: Methods: Using a mixed-methods, longitudinal, patient-interview design, N = 29 (to date) women with a history of AAN have been enrolled. Each patient completed a diagnostic interview and standardized surveys to establish ED diagnosis, severity, and associated psychopathology. Transcribed, semi-structured qualitative interviews are assessed for common themes using content analysis methods. RESULTS/ANTICIPATED RESULTS: Anticipated Results: Patients aged 18 to 74 (M = 36.3, SD = 12.0), with mean BMI = 39.8 (22.7-61.1; SD = 11.3), and mean weight suppression (lbs) during their illness = 119.41 (SD = 69.3). Women reported a mean=12.75 years (0-37 years, SD = 10.5) treatment delay. Qualitative analysis revealed the following barriers in healthcare provider interactions: 1) experiences of provider weight-bias, 2) low specificity in ED screening questions, 3) lack of indicated screening procedures/diagnostic tests (orthostatic screening, EKG, food log, labs), and 4) provider praise of ED behaviors. Facilitators: 1) lower BMI at presentation, 2) provider education in EDs, 3) community-provider collaboration, and 4) patient self- and family- advocacy. DISCUSSION/SIGNIFICANCE OF IMPACT: Discussion: Unfortunately, while early intervention best predicts positive outcomes, higher-weight patients in this study experienced significant treatment delay. Translationally, it is taking too long for AAN patients to receive the right treatment at the right time. However, findings indicate that interventions at the provider level (increasing ED education, building community partnerships, increased adherence to screening protocols) could improve screening, diagnostic, and referral practices—and ultimately long-term outcomes for this unique patient population.

OBJECTIVES/GOALS: The primary purpose of the QA/QC Project Manager (PM), appointed under the NCATS UL1 administrative supplement award, is to facilitate quality and timely NCATS prior approval submissions preventing study start delays. Other goals include supporting these projects’ IRB applications and monitoring to ensure data quality and compliance. METHODS/STUDY POPULATION: At the Indiana CTSI, the QA/QC PM is assigned to the Regulatory Knowledge and Support program (RKS) and functions as a unique regulatory service provider. Through monitoring, auditing, and personalized consultations, the IN CTSI QA/QC PM provides study teams with regulatory, GCP, and other compliant study conduct insights while managing NCATS prior approval and RPPR submission quality and timeliness. In contrast to many CTSAs, this role is uniquely situated within RKS and provides QA/QC support through a regulatory lens. The Indiana CTSI QA/QC PM serves on the CTSA QA/QC Lead Team collaborating with NCATS and other CTSA QA/QC personnel. The Lead Team engages with NCATS to host monthly/quarterly meetings and participate in a discussion forum of NCATS and other CTSA QA/QC personnel. RESULTS/ANTICIPATED RESULTS: Not all CTSAs employ the QA/QC PM as regulatory support and the role and skill sets at each CTSA vary, yet the collaborative nature of these individuals across the CTSAs facilitates sharing of resources and knowledge. While prior approval and RPPR submissions vary widely, the QA/QC PMs can rely on their counterparts for guidance complying with the same regulations and policies within unique research settings and institutional nuances. The IN CTSI QA/QC PM, in collaboration with the QA/QC Lead Team, provided quality assurance revisions to the NCATS prior approval instructions which were adopted and published by NCATS January 2022 for implementation at all CTSAs. Ongoing, quality control efforts are accomplished through education, monitoring, and regulatory consultations. DISCUSSION/SIGNIFICANCE: As the research environment evolves, the QA/QC PM responsibilities shift in response to needs within RKS and NCATS. The versatility of the position enables QA/QC to occur at all stages of a study. QA/QC strategies aim to facilitate communication, quality NCATS prior approval and RPPR submissions, and compliance with proposed study conduct.

OBJECTIVES/GOALS: To identify challenges faced by academic researchers in accessing online regulatory information and/or tools to advance their research work to develop a free, publicly accessible, interactive web portal that provides regulatory support. METHODS/STUDY POPULATION: The Regulatory Knowledge and Support core of the Southern California Clinical and Translational Science Institute interviewed five local research professionals. These interviews guided the development of a Qualtrics survey, consisting of multiple responses and open-ended questions, submitted to our local institutional review board (IRB). After receiving IRB approval, the survey was disseminated via email, newsletters, flyers, and presentations targeting researchers at academic institutions and members of clinical and translational science hubs. Survey data will be used to identify the challenges academic researchers face in finding regulatory resources and to compile the types of regulatory information or tools they would find helpful for their research. RESULTS/ANTICIPATED RESULTS: According to the interviews, researchers with extensive involvement in clinical trials found regulatory resources easily accessible compared to those with less experience. Additionally, they all stated having a colleague or regulatory specialist whom they can consult about regulatory requirements. Insights from these initial interviews confirmed the need to obtain a comprehensive view across research professionals. Anticipated results will show the challenges in accessibility, source, and type of regulatory resources researchers typically encounter. It is also anticipated that researchers will share what kinds of resources they would find most useful for their work. Ultimately, the information and tools identified as essential by survey takers will be collected and incorporated into the web portal. DISCUSSION/SIGNIFICANCE: Academic researchers find navigating through regulatory hurdles persistently challenging when translating their work from bench to clinic, especially since academia is typically resource-constrained. Findings from this study will allow the creation of a web portal for researchers that is broadly accessible and meets their regulatory needs.

OBJECTIVES/GOALS: Although their 5-year survival >90%, young patients with HL face tradeoffs between near-term disease control and risk of treatment-related adverse effects decades later, so we seek to understand what patients and clinicians value in HL treatment decisions. METHODS/STUDY POPULATION: Leveraging our access to large cohorts of physicians, HL patients/survivors, and caregivers, we will use adaptive choice-based conjoint analysis (ACBC) to elicit treatment preferences when offered scenarios that incorporate tradeoffs, e.g., would a patient rather live 20 years with 10% risk of second malignancy or live 40 years with 30% of second malignancy. To reduce survey fatigue, prior choice responses limit subsequent scenarios. Through ACBC, we will identify variations in preferences and the importance of disease outcomes, treatment characteristics, and late effects for HL by respondent type. RESULTS/ANTICIPATED RESULTS: The goal is a final sample of 200 physicians and 200 patients/caregivers. We will collect demographics from physicians (age, type of physician, years practicing, type of practice, gender, and geography) and patients/caregivers (age at diagnosis, time since treatment, race, gender, smoker, education). We will ask questions about values of disease outcomes, late effects (second cancers, cardiac disease, chronic fatigue and neuropathy), and treatment characteristics (uncertainty of late effects, salvageability). Results will include utilities about participants views on disease-control and late effects. We anticipate participants to value disease control over late effects. DISCUSSION/SIGNIFICANCE OF IMPACT: Our study will elicit how physicians and patients/caregivers value treatment tradeoffs for HL. In an era of multiple treatment choices with varying short- and long-term benefits and harms, identifying values and preferences become critical for patient-centered treatment decisions.

OBJECTIVES/SPECIFIC AIMS: According to Diffusion of Innovations Theory, an important predictor of successful implementation of a new intervention within an organization is perceived need for change (i.e. tension for change [TFC]). No research has examined factors influencing TFC in relation to human papillomavirus (HPV) vaccination. Providers who assume their clinic already performs well in HPV vaccination coverage may perceive a lower need for assistance for improvement. We assessed the association between perceived HPV vaccine completion compared to peer clinics and perceived support needed to increase HPV vaccination coverage. METHODS/STUDY POPULATION: All providers (physicians/nurse practitioners/physician assistants) and staff (clinical/non-clinical) from 21 pediatric clinics participating in an HPV vaccine quality improvement (QI) intervention study in Tennessee were invited to complete a baseline survey. Perceived comparative performance (i.e. perceived HPV vaccine completion compared to peer clinics) and TFC (i.e. perceived support needed to increase HPV vaccination coverage) were measured on continuous scales of 0-100. We used logistic regression to estimate odds of perceiving higher TFC (upper tertile, score of 51-100) for every unit increase in perceived comparative performance. Analyses controlled for age of respondent, perceived strength of evidence for HPV vaccine guidelines, and clinic factors, including culture/climate and available resources. RESULTS/ANTICIPATED RESULTS: Of 325 respondents, most were staff (61%), female (87%), and non-Hispanic White (83%). Respondents who perceived higher HPV vaccination coverage compared to peer clinics perceived lower clinic-level TFC (adjusted OR [aOR] = 0.98; 95% CI, 0.97-0.99). When stratifying by job role, this negative association was observed among providers (aOR = 0.95; 95% CI, 0.92-0.98), but not among staff (aOR = 1.00; 95% CI, 0.98-1.03). DISCUSSION/SIGNIFICANCE OF IMPACT: Providers who perceived higher HPV vaccination coverage compared to peer clinics perceived lower need for support to improve vaccination outcomes. Our results suggest that QI efforts targeting pediatric clinics may find it useful to assess providers’ perceptions of their clinic’s performance, which could affect motivation to engage in QI efforts and successfully improve outcomes.

OBJECTIVES/GOALS: Examine the use of Patient-Reported Outcomes (PRO) in Huntington’s Disease (HD) clinical trials (CT) and compare across time and sponsor types. METHODS/STUDY POPULATION: Conduct literature review on 1. background of HD, 2. what symptoms and outcome measures are most important to patients, including the Patient-Focused Drug Development (PFDD) meeting for HD–led by the U.S. Food and Drug Administration (FDA), 3. what outcome measure tools currently exist and what they measure. Utilizing Clinicaltrials.gov, trials for HD were examined to assess the number of trials conducted, what COAs were used, and funding types. Trials were filtered by study type (keep Interventional) and status (filter out suspended, terminated, unknown, and withdrawn). The frequency of COAs will then be mapped based on the symptoms from the PFDD meeting. RESULTS/ANTICIPATED RESULTS: From the PFDD meeting for HD, symptoms that were important to patients include cognitive impairment, depression and anxiety, and motor symptoms. From the 139 interventional studies that were active, complete, recruiting, or not recruiting, 79 studies were conducted by Industry, 3 by NIH, 93 by Other (Academia/Community Organizations), and 1 by a U.S. Federal Agency (other than NIH). One of the most commonly used COA is the Unified Huntington’s Disease Rating Scale (UHDRS), which includes a motor, cognitive, and behavior assessment, and an assessment on functional capacity and independence. Of the 27 out of 139 trials analyzed to date, there were a total of 37 COAs. DISCUSSION/SIGNIFICANCE: The widespread use of UHDRS can be attributed to its standardization in 1999. It captures the symptoms of HD that are most important to patients. Because UHDRS is not sensitive to any one symptom, other COAs have been developed which focus on unique aspects of HD and allow for its earlier detection.

OBJECTIVES/GOALS: To identify possible failures that could occur in the delivery of an evidence-based parenting program for mothers with substance use disorders (SUD) through existing home-visiting services, and to develop solutions to the most significant failures. METHODS/STUDY POPULATION: Using failure modes and effects analysis (FMEA) methodology, we conducted two 2-hour advisory panel discussions with 15 people from a variety of disciplines and life experiences related to SUDs. The intervention delivery process included five steps: (1) Recruitment, (2) Screening, (3) Matching, (4) Enrollment in person, and (5) Intervention delivery. Participants collectively determined possible failures, causes, and consequences. Participants then agreed on three scores (Likert Scale 0-10) for the likelihood of occurrence, detection, and severity of the failure, with 10 being the highest likelihood, difficulty detecting, or severity. A risk priority number (RPN) was calculated as the product of the 3 scores (maximum RPN = 1,000). The group then identified possible solutions for failures with higher RPNs. RESULTS/ANTICIPATED RESULTS: For each step in the process we identified the following number of failure nodes and RPN scores: (1) recruitment: 13 failures; RPN = 800, (2) screening: 102 failures; RPN = 10, (3) matching: 4 failures: RPN = 490, (4) enrollment: 6 failures; RPN = 80, (5) delivery: 11 failures; RPN = 80. The most critical failures related to recruitment and were perceived as being caused by potential development of mistrust in the community. Participants strongly encouraged the use of “strengths-based language,” clear referral plans for mothers that did not qualify, and inclusion of mothers that did not have custody of their children. These findings resulted in changes to the screening script, enrollment procedures, and inclusion criterial for the program. DISCUSSION/SIGNIFICANCE OF IMPACT: FMEA methodology was particularly effective in identifying possible failures for the integration of an evidence-based parenting program into existing home-visiting services as they related to the psychological safety of mothers with SUDs. The process resulted in direct changes to procedures for the anticipated program integration and study.

The National Center for Advancing Translational Sciences (NCATS) has defined translation as the process of turning observations into interventions that are adopted, sustained, and improve health. Translation must attend to research and community systems and context at multiple levels, and to key stakeholders. Dissemination and implementation (D&I) sciences are informed by an understanding of the critical role of people and systems in disseminating, adopting, and sustaining innovations within real-world settings. Thus, the D&I sciences provides a set of principles that can guide the translational work of Clinical and Translational Science Award (CTSA) programs from basic research to public health. In this special communication, our cross-domain working group of the CTSA consortium, comprised of experts in methods and processes, workforce development, evaluation, stakeholder engagement, and D&I sciences, share a vision of how CTSAs can enhance translation across the translational spectrum through the integration of D&I sciences into the critical areas of methods and processes, workforce development, and evaluation. We propose a set of recommendations for NCATS national and local leaders that are intended to move D&I sciences out of a position of unfamiliarity and ancillary value and into the core identity of who CTSAs are, how they think, and what they do, to advance translation and health.

Clinical trial processes are unnecessarily inefficient and costly, slowing the translation of medical discoveries into treatments for people living with disease. To reduce redundancies and inefficiencies, a group of clinical trial experts developed a framework for clinical trial site readiness based on existing trial site qualifications from sponsors. The site readiness practices are encompassed within six domains: research team, infrastructure, study management, data collection and management, quality oversight, and ethics and safety. Implementation of this framework for clinical trial sites would reduce inefficiencies in trial conduct and help prepare new sites to enter the clinical trials enterprise, with the potential to improve the reach of clinical trials to underserved communities. Moreover, the framework holds benefits for trial sponsors, contract research organizations, trade associations, trial participants, and the public. For novice sites considering future trials, we provide a framework for site preparation and the engagement of stakeholders. For experienced sites, the framework can be used to assess current practices and inform and engage sponsors, staff, and participants. Details in the supplementary materials provide easy access to key regulatory documents and resources. Invited perspective articles provide greater depth from a systems, DEIA (diversity, equity, inclusion, and accessibility) and decentralized trials perspective.

OBJECTIVES/SPECIFIC AIMS: This is a prospective, longitudinal cohort study correlating postoperative opioid use, prescription availability at discharge and patient use at home using survey methodology and longitudinal cohort data. The primary objectives of this project are twofold. First, we will determine whether the number of opioid pills prescribed after surgery increases the risk of abuse, diversion and conversion to chronic use. Next, we will determine whether patient and parent characteristics, behavioral factors and medical comorbidities increase the risk of opioid abuse, diversion and conversion to chronic use after surgery. METHODS/STUDY POPULATION: A mixed-methods approach will be employed utilizing retrospective and prospective medical record review, survey methodology, and longitudinal cohort matching with California’s Controlled Substance Utilization Review and Evaluation System (CURES) reports of opioid usage. Surveys will be administered before and after surgery and will capture both parent and patient level factors that may influence longitudinal opioid use. Adolescents and young adults 13-20 years old discharged from Children’s Hospital Los Angeles undergoing one of seven procedures most commonly associated with an opioid prescription at time of discharge (spinal fusion, arthroscopy, bowel resection for inflammatory bowel disease, pectus excavatum repair, tonsillectomy, pilonidal excision and hip reconstruction) will be enrolled. RESULTS/ANTICIPATED RESULTS: Inpatient and outpatient opioid usage will predict incidence of diversion, abuse and conversion to chronic usage. Furthermore, socioeconomic factors and behavioral comorbidities such as anxiety and depression will be identified as predictors of diversion, abuse and conversion to chronic opioid use. DISCUSSION/SIGNIFICANCE OF IMPACT: This study will be one of the first to identify opioid prescribing variation in children who require surgery and will identify multiple provider, patient and family level factors influencing use. Furthermore, it will identify factors predictive of possible diversion, abuse and conversion to chronic use. The results of this exploratory analysis will lay the foundation for future studies utilizing physician decision support tools, aid in crafting “best practice” patterns and clinical benchmarks for opioid prescribing, and serve to inform policy makers on the most impactful ways to optimize opioid prescribing practices for adolescents who require surgery.

OBJECTIVES/SPECIFIC AIMS: Our overall objectives are to determine (i) whether natural disaster-related prenatal maternal stress (PNMS) alters infants’ effortful control (EC) at two years of age, and (ii) if the timing of exposure moderates its effects on toddlers EC. METHODS/STUDY POPULATION: We propose a longitudinal study with 50 mother-toddler dyads. Natural disaster-related PNMS would be measured at 12-15 and 18-24 months of age and will include: objective exposure and maternal distress. EC will be measured with a questionnaire and a Laboratory Temperament Assessment Battery at two years of age. RESULTS/ANTICIPATED RESULTS: We anticipate that children exposed to Hurricane-related PNMS would present low EC levels compared to those with low prenatal exposure. DISCUSSION/SIGNIFICANCE OF IMPACT: These results are expected to provide evidence for further promoting early intervention and ameliorating negative effects of PNMS on child outcomes.

OBJECTIVES/SPECIFIC AIMS: Understand the association between ADI and completion of preventative cancer screening and high risk behaviors -Identify how to operationalize ADI in clinical settings to assist care teams and improve overall care delivery. METHODS/STUDY POPULATION: Aim 1: Paneled Mayo Clinic patients living in MN, IA, or WI Aim 2: BRFSS survey respondents from MN, IA, or WI Aim. 3: Community health officials and Mayo Clinic care teams. RESULTS/ANTICIPATED RESULTS: We anticipate that areas with greater composite deprivation will have lower completion rates of cancer screening and higher risk behaviors. DISCUSSION/SIGNIFICANCE OF IMPACT: No single body of work has illustrated how ADI relates to completion of preventative cancer screening and high-risk behaviors. Due to the limited research focused on area deprivation and behavioral health, our work will identify some of the first national hot spots with high deprivation and high-risk behaviors. Additionally, this is one of the first studies describing spatial variation in health outcomes for Mayo Clinic patients. Understanding the association between ADI and patient adherence to preventative screening will allow us to support care teams in providing personalized and sustainable care for patients living in areas of high deprivation. The strength and novelty of this project is in the utility of the mixed methods design, which provides a more complete understanding of geographic disparities and a unique perspective to patient care, a perspective that is not portrayed in existing literature.

OBJECTIVES/GOALS: To validate the previously developed ototoxicity prediction model for objective (i.e., audiometric-defined) hearing loss from cisplatin-based and radiation treatments in a new cohort of head and neck cancer patients treated from 2018 to 2019. METHODS/STUDY POPULATION: This study will use a cohort of 106 patients undergoing treatment for head and neck cancers at a single institution to temporally validate a model for post-treatment ototoxicity. We are interested in understanding if this model will be able to predict ototoxic risk (calibration) and if this model can differentiate high- and low-risk patients (discrimination). Observed and predicted values for audiometric hearing loss will be calculated and then compared using a calibration curve available in SAS v9.4, while the c-index (area under the receiver-operator curve) will be used to assess discrimination. The implementation of this model will be assessed in a clinical setting. RESULTS/ANTICIPATED RESULTS: The validation cohort is generally similar in age (61 years) and sex-mix (23% female) to the original cohort. However, there seems to be a different case-mix the types of treatments with more patients receiving cisplatin overall (59% vs. 43%), but fewer getting induction and high-dose cisplatin (1% vs. 13%). The original model showed good calibration and fair discrimination in the validation cohort with and area under the curve of 0.700. This concordance statistic suggests possibly-useful discrimination and the calibration curve suggests the model is well-calibrated. DISCUSSION/SIGNIFICANCE OF IMPACT: This project can improve clinical treatment paradigms, enhance patient education, and reduce healthcare costs. Our model allows oncologists to weigh the risks of hearing loss with the benefits of treatment on an individualized level before treatment, facilitating informed treatment decision-making.

OBJECTIVES/GOALS: This study’s goal is to examine the feasibility and acceptability of using VRM to impact the APP of adults in the inpatient setting. Aims include examining the: 1) feasibility of VRM for APP management; 2) acceptability of using VRM for APP management; and 3) experience of VRM for APP management. METHODS/STUDY POPULATION: To comprehensively examine participants’ experience of using VRM for APP, this study will employ a convergent mixed-methods design in which living kidney donors (N = 45) will be recruited to serially use VRM during their hospital stay. Feasibility and acceptability will be evaluated using descriptive and inferential statistics evaluating patient-reported outcome (PRO) measures taken pre-, post- and 1-hour post-VRM, PRO measures extracted from the participant’s electronic health record and data on VRM use. Semi-structured interviews will allow formulation of inferences based on participants’ experience of VRM for APP management and their insights on content, deployment, and clinical use of VRM. RESULTS/ANTICIPATED RESULTS: This in-process study expects: 1) an adequate sample of participants undergoing living kidney donor surgery who agree to enroll with retention of >90% of participants (Aim 1); 2) participants to report VRM as an acceptable and suitable treatment, feel “present” and interested in the VR environment, and feel comfortable using VRM in the hospital (Aim 2); and 3) to provide insight into participants’ experience of VRM for APP, understanding of extended VRM use for APP analgesia, examination of key variables affecting participants’ experience of VRM for APP and feedback about VRM procedures and protocol to inform future VRM use for APP management (Aim 3). DISCUSSION/SIGNIFICANCE OF IMPACT: Results of the proposed study will inform future clinical testing and deployment of VRM, guide future use of VRM as an adjunct for inpatient APP management, and provide insight into inpatients’ experience of VRM for APP analgesia.

OBJECTIVES/GOALS: The FDA allows physicians to request clinical use of investigational drugs, biologics, and devices for patients with no satisfactory treatment options through a pathway called Expanded Access (EA). TEAMSS (Transforming Expanded Access to Maximize Support and Study) sought to examine single-patient cases to better characterize these patients. METHODS/STUDY POPULATION: We prospectively collected data on requests for single-patient EA at any one of the four collaborating TEAMSS institutions (Duke University, University of Rochester, University of Michigan, and University of Texas Southwestern) between September 1, 2021 and February 28, 2023. Regulatory and health records were reviewed for past cases that occurred between June 1, 2018 and August 31, 2021. Descriptive statistics were performed on data from the submission process, the patient demographics, the indication for treatment, and patient health status over time. RESULTS/ANTICIPATED RESULTS: The patient population was representative with respect to the largest racial groups (69.3% White / 13.0% Black or African American) and legal sex (51.3% male / 48.7% female). All ages were represented, with overrepresentation of those 60-70 years old (16.8%) and under 10 (14.8%). Patients were most often treated for infectious diseases (44.2%) or oncologic conditions (39.0%). Those who received more than one dose stayed on treatment for 76 days (median) and up to 1427 days (maximum). At the end of study, 53.9% had completed treatment as planned, moved to commercial product, or continued treatment. Death, disease progression, or failure to respond occurred for 31.9% of patients. DISCUSSION/SIGNIFICANCE: The population that receives Expanded access treatments is heterogeneous in both demographics and medical conditions. Some successful treatments are continued for years. Many patients complete their treatment, and a minority experience death or disease progression during treatment.

OBJECTIVES/GOALS: Mayo Clinic (MC) launched the Rapid Activation Trial (RAT) pilot program in 2022 to expedite the activation of high priority and high impact clinical trials. The objective was to develop a process for rapid activation through robust screening, prioritization, and project management (PM) support. METHODS/STUDY POPULATION: The project team developed a robust screening and approval process for the RAT program using a combination of an objective scoring tool (based on strategic priorities) and a diverse selection committee to screen and approve eligible trials. Sponsors had to commit to RAT program timelines. Upon approval, trials were prioritized at the highest level within each business unit involved in the activation process. The number of trials approved annually were limited to 8 to manage volume and facilitate seamless prioritization with an activation timeline goal of 6 weeks. Project management support for RAT program focused on financial, regulatory, logistical, and operational elements to open trials expeditiously. RESULTS/ANTICIPATED RESULTS: In 2022, thirteen (13) applications were received and eight (8) were approved by the RAT selection committee. The approved trials activated with a median open to enrollment time of 6.4 weeks from engaging with business units. They also aligned closely with organization’s strategic priorities, including but not limited to Investigator Initiated Trials, Multi-Site protocols, IND/IDE protocols, Rare Diseases, First in Human and Commercialization potential trials. PI and study team feedback was positive. In 2023, the RAT program was renewed due to the pilot’s significant success in 2022. The goal is to open 10 trials and 5 have been activated by the end of Q3, 2023 with a median timeline of 6 weeks. DISCUSSION/SIGNIFICANCE: Rapid activation of high priority and high impact clinical trials enables an organization to strategically prioritize and open complex clinical trials. This allows the delivery of innovative, timely cures to patients in an expeditious timeline.

The efficient and effective movement of research into practice is acknowledged as crucial to improving population health and assuring return on investment in healthcare research. The National Center for Advancing Translational Science which sponsors Clinical and Translational Science Awards (CTSA) recognizes that dissemination and implementation (D&I) sciences have matured over the last 15 years and are central to its goals to shift academic health institutions to better align with this reality. In 2016, the CTSA Collaboration and Engagement Domain Task Force chartered a D&I Science Workgroup to explore the role of D&I sciences across the translational research spectrum. This special communication discusses the conceptual distinctions and purposes of dissemination, implementation, and translational sciences. We propose an integrated framework and provide real-world examples for articulating the role of D&I sciences within and across all of the translational research spectrum. The framework’s major proposition is that it situates D&I sciences as targeted “sub-sciences” of translational science to be used by CTSAs, and others, to identify and investigate coherent strategies for more routinely and proactively accelerating research translation. The framework highlights the importance of D&I thought leaders in extending D&I principles to all research stages.