Clinical And Translational Science Institute Research Articles

99 Using LGBTQ+ Community Expertise to Co-Develop Inclusive Sexual Orientation and Gender Identity (SOGI) Screening for Research Studies

OBJECTIVES/GOALS: To promote diverse research engagement and address health disparities by creating an inclusive tool to collect sexual orientation and gender identity (SOGI) data from potential participants #_msoanchor_1 METHODS/STUDY POPULATION: The Penn State Community Health Equity & Engagement in Research (CHEER) team, part of our Clinical and Translational Science Institute (CTSI), developed inclusive screening guidance to collect SOGI data from potential research participants to fill an identified gap in the literature. Guidance was developed through an iterative feedback process, leveraging expertise from local, regional, and national organizations, healthcare systems, and leaders throughout Clinical & Translational Science Award hubs. By eliciting expert feedback, CHEER co-developed a comprehensive SOGI data collection form, filling an important gap of inclusivity in the consenting process. Training of this new tool was delivered to CHEER’s far-reaching listserv researchers (internal and external) and community partners. RESULTS/ANTICIPATED RESULTS: Feedback collected from our LGBTQ+ expert partners resulted in a total of five inclusive SOGI screening questions; two ‘Gender Identity’ questions, one ‘Sexual Orientation’ question, and two ‘Sex’ questions, with “prefer not to answer” and “another option not listed” provided. The goal of this effort is to equip research teams with a tool that integrates SOGI characteristics that may be particularly important to determine study eligibility respective to a person’s identity or orientation. Additionally, collecting SOGI data in an inclusive way may increase trust worthiness in research from potential research participants, particularly among the LGBTQ+ community, who have been underrepresented yet experience several inequities and disparities across multiple health outcomes. DISCUSSION/SIGNIFICANCE: CHEER’s goal is to reduce health disparities in underrepresented populations, including the LGBTQ+ community, by promoting inclusivity and engagement in research. Developing a community-driven screening that addresses the unique needs of the LGBTQ+ community successfully bridges a gap in equity across all research participants.

142 Using evaluation methods to improve evaluation processes: Creation and implementation of a new continuous improvement process at Duke Univ. Clinical and Translational Science Institute (CTSI)

OBJECTIVES/GOALS: (1) Assess challenges with our current continuous improvement processes via stakeholders. (2) Implement a revised continuous improvement process. (3) Evaluate the revised processes to assess implementation and use for strategic improvement. (4) Implement analysis mechanisms for new process to assess trends across the CTSI. METHODS/STUDY POPULATION: We used a mixed-methods, multi-phased, stakeholder-engaged approach with different processes per objective. Obj. 1: We implemented focus groups, surveys, and listening sessions incorporating two populations: both teams required to participate in reporting process, and CTSI leadership. Obj. 2: We utilized data from Obj. 1 processes to develop a revised continuous improvement process. Obj. 3: We integrated qualitative feedback processes onto the structure of continuous improvement processes, and we implemented a survey to assess use and value for the new process. Obj. 4: We developed a qualitative coding schema to assess key trends across teams and over time. RESULTS/ANTICIPATED RESULTS: Obj. 1: Numerous challenges in metrics format and process, including significant limitations in data use to inform decision-making and appropriately assess impact. Obj. 2: Resultant changes to continuous improvement processes, including a restructured reporting format and use-oriented approach that enhanced organizational integration; changes included added focus on facilitators of success, challenge, and key opportunities to better inform decision-making. Obj. 3: The majority of teams experienced the new quarterly process as a better tool for program monitoring and communicating program needs to leadership, but that fuller integration into vertical communication is needed. Obj. 4: Implementation of new analysis process enabling examination of trends and themes across diverse teams within the CTSI. DISCUSSION/SIGNIFICANCE: This work has particular relevance within ACTS given our focus on a clinical and translational research enterprise, the complexity in evaluating the diverse work of translation research entities, and limitations in a commonly-used metrics-monitoring approach. Our focus on improving translational processes advances translational science.

82 Tools to facilitate participant recruitment into research studies: Assessing early outcomes following implementation

OBJECTIVES/GOALS: The objective of this presentation is to describe different recruitment tools implemented by the Miami Clinical and Translational Science Institute (CTSI) to facilitate participant recruitment into research studies. METHODS/STUDY POPULATION: Participant recruitment is critical to the success of all research studies. In the effort of advancing clinical and translational science and to help investigators recruit volunteers for research studies, the University of Miami has two recruitment tools: 1) Consent to Contact (CTC), an opt-in research registry where University of Miami Health System patients are asked for permission to be contacted about studies matching their demographic and/or health profiles; and 2) UMiamiHealthResearch.org (UMHR), implemented with the Michigan CTSA, a community-based registry for volunteers to sign up and be contacted about studies. Study investigators can use these tools once they have obtained IRB approval for their research. RESULTS/ANTICIPATED RESULTS: The CTC was launched in 2016; to date, over 130,000 patients have enrolled in CTC; 69 studies have been approved with over 75,000 patients’contact information released to study teams. UMHR was launched in 2020. To date, the site lists 237 studies. A total of 2,727 portal visitors have expressed interest in participating in specific studies. Study team members were successful in engaging interested participants, and enrolling participants into studies. Overall, teams reported a positive impact on recruitment. Data collection on utilization and satisfaction of these recruitments tools is ongoing. In addition, focus groups of study team members are being conducted to identify best practices for using these tools, and findings will be presented. DISCUSSION/SIGNIFICANCE: The CTC and UMHR recruitment tools have demonstrated positive impact in helping study teams identify potentially eligible research volunteers. The continued promotion of these tools at the University of Miami Health System and in the community will be crucial to the recruitment process and execution of research studies.

166 Community Driven Research Day: Addressing Community Needs in Rural Pennsylvania

OBJECTIVES/GOALS: Describe the community of Norther Dauphin County, PA and increase awareness of this community’s health related needs. Establish partnerships between Penn State faculty and Northern Dauphin County community-based organizations to develop an optimal approach to address identified health related needs. METHODS/STUDY POPULATION: Northern Dauphin is located in the rural Northern Tier of Dauphin County, PA and has roughly 30,000 residents within 272 square miles. Of those residents, approximately 1 in 4 families live below the poverty level. Although over 6,000 residents receive Medical Assistance (MA), only one local provider accepts MA covered patients. Residents have limited access to health care due to the rurality of the area when paired with a lack of public transportation. The Penn State Clinical and Translational Science Institute (CTSI) Community Engaged Research Core (CERC) has partnered with Northern Dauphin County community- based organizations to explore the needs of community members and how partnerships with Penn State Faculty could help to address the community needs. RESULTS/ANTICIPATED RESULTS: A Community Advisory Board (CAB) of leaders (e.g., school officials, business owners) was created to identify community needs. After an initial workshop with the CAB, an assessment was created and distributed to the larger community to identify the top community health needs. Details from the assessment were then used to prioritize the themes for the Community Driven Research Day (CDRD). The CERC team identified Penn State University faculty with research interests related to these prioritized themes. The faculty identified and community leaders were then invited to the CDRD. The agenda for the event included an introduction to Community Engaged Research, a presentation from a researcher and community partner working together, round table discussions based on the themes selected, and an overview of pilot grants. DISCUSSION/SIGNIFICANCE: The CDRD will facilitate partnerships between the Penn State faculty and local community leaders to help effectively move forward addressing the community’s health needs. The PSU CTSI will offer pilot grants to formalize and strengthen these partnerships and conduct community engaged research initiatives to discover optimal ways to address them.

211 Using team science to support outbreak management in a large urban region during the COVID-19 pandemic

OBJECTIVES/GOALS: To describe how the UCLA Clinical and Translational Science Institute (CTSI) assembled and deployed a science team in support of a local jurisdictions effort to manage and control COVID-19 outbreaks in one of the nations largest metropolitan regions, Los Angeles County (LAC). METHODS/STUDY POPULATION: During the COVID-19 pandemic (2020-21), building an efficient data infrastructure to support outbreak management became a priority for the local health department. In response, the UCLA CTSI assembled a science team with expertise across the translational continuum: epidemiology, laboratory and microbiology, machine learning, health policy, medicine and clinical care, and community engagement. The team partnered with a new LAC Data Science Team to foster a collaborative learning environment for scientists and public health personnel, employing improvement and implementation science to help mitigate COVID-19 outbreaks in sectors including healthcare, skilled nursing facilities, and K-12 education. The goal was a public health workforce that is prepared to problem-solve complex, evolving outbreaks. RESULTS/ANTICIPATED RESULTS: The science team created a learning environment with data modeling and visualization, problem-based learning, and active knowledge and skills acquisition. First, control charts and time series methods were used to visualize COVID-19 data and find signals for action. Second, a series of 16 Grand Rounds offered interactive sessions on problem-solving of outbreak challenges in different sectors. Third, a biweekly Public Health Digest provided fieldworkers with the latest scientific studies on COVID-19. All three elements guided and empowered the workforce to implement timelier, efficient outbreak mitigation strategies in the field. The partnered team also identified barriers to adoption of selected new data and management techniques, revealing areas for further skill-building and data-driven leadership. DISCUSSION/SIGNIFICANCE: The UCLA CTSI science team offered a backbone science infrastructure for helping public health and other sector agencies manage COVID-19 outbreaks and mitigation. It showed promise in bringing and translating science into public health practice. It revealed future priorities for CTSI innovation and scientific support of public agencies.

115 Interactive data displays for rapid responses to COVID-19 response in K-12 schools

OBJECTIVES/GOALS: A UCLA Clinical and Translational Science Institute (CTSI) science team partnered with the second largest US school district, with over 500,000 K-12 students, to design and implement a statistical process control dashboard to guide COVID-19 response, including mitigation and vaccination outreach. METHODS/STUDY POPULATION: District data for students, teachers, and staff are updated daily and include COVID-19 test results, counts of quarantine after positive tests, and COVID-19 vaccination rates. Displays used a new hybrid Shewhart control chart to detect changes in test positivity rates and distinguish meaningful signals from noise (random day-to-day variation). The dashboard uses the Shiny and plotly packages in R to display interactive graphs of each data stream (cases, tests, and vaccinations) charted at multiple levels (districtwide, subdistricts, schools). Displays of variation over time show policy impacts and inequities. Selected displays use municipal COVID-19 data to complement district data. RESULTS/ANTICIPATED RESULTS: The district has used the displays to assess the impact of their COVID-19 response and to identify variation in close to real-time to suggest areas with need for additional resources for mitigation or vaccination. The CTSI team has continued to edit and add displays in response to the district’s changing operational needs and questions. DISCUSSION/SIGNIFICANCE: The UCLA CTSI team developed and implemented a robust data visualization dashboard to monitor COVID-19 case rates and plan vaccination outreach efforts. Control charts enabled the district to distinguish noise from signal, thereby rapidly identifying when specific parts of the district needed targeted support to achieve equity goals.

Fostering diversity and a culture of inclusion in clinical research by training and hiring community members as clinical research assistants.

The University of Pittsburgh (Pitt) Clinical and Translational Science Institute (CTSI) and the nonprofit Bidwell Training Center co-developed a new program for translational workforce diversification and development to foster diversity and inclusion in clinical research. The STricklAnd Research Training (START) program provides students in the Medical Assistant program at Bidwell a career path in clinical research. We created a 12-hour didactic package that covers responsible conduct of human subjects research and good clinical practice as an add-on to existing vocational curriculums. Students have the option of completing a clinical research-related externship at Pitt, which includes mentoring, shadowing, and protocol-specific training on a study team whose intention is to hire them as a clinical research assistant. Those who accept a position at Pitt receive continued mentorship, education, and professional development through Pitt CTSI. In the first three cohorts, two of which had access to research externships at Pitt, 92% of students successfully completed the instruction in clinical research. We plan to expand START to new venues to train and hire local community members from diverse backgrounds who can bring their lived experience to research programs.

Myocardial Injury After Noncardiac Surgery-Slightly Heavier May Be Better.

Myocardial Injury After Noncardiac Surgery-Slightly Heavier May Be Better.

Creating effective academic research teams: Two tools borrowed from business practice.

Academic Medical Centers strive to create multidisciplinary research teams to produce impactful science. However, few faculty researchers receive training in "team science," a well-established concept in business research and practice. Responding to demand for assistance developing effective research teams, the Collaboration and Team Science Program of the Clinical and Translational Science Institute (CTSI) at Wake Forest School of Medicine (WFSM) partnered with faculty from the Wake Forest University (WFU) School of Business with expertise in leadership, management, and team building. We initiated a needs assessment, including a written survey from a diverse set of 42 research scientists as well as semi-structured interviews with 8 researchers. In response to identified needs, we developed training sessions and consultations to teach teams to implement two tools known to enhance team dynamics: (1) Team charter, a document that defines the team's purpose, goals, roles, and strategies; and (2) Responsible, Accountable, Consulted, Informed (RACI) matrix, a table or spreadsheet that clarifies tasks and accountability. Since 2018, 10 teams and over 100 individuals have attended training sessions and 6 teams received personalized team consults. We describe these tools, present a formal analysis of quantitative results, and highlight the next steps being taken in response to these findings.

Pilot test of an accrual Common Metric for the NIH Clinical and Translational Science Awards (CTSA) Consortium: Metric usefulness.

The Common Metrics Initiative aims to develop and field metrics to improve research processes within the national Clinical and Translational Science Award (CTSA) Consortium. A Median Accrual Ratio (MAR) common metric was developed to assess the results of efforts to increase subject accrual into a set of clinical trials within the expected time period. A pilot test of the MAR was undertaken at Tufts Clinical and Translational Science Institute (CTSI) with eight CTSA Consortium hubs. Post-pilot interviews were conducted with 9 CTSA Principal Investigators (PIs) and 23 pilot team members. Over three-quarters (78%) of respondents reported that the MAR could be useful for performance improvement, but also described limitations or concerns. The most commonly cited barrier to MAR use for performance improvement was difficulty in interpreting the single value that is produced. Most respondents were interested in using the MAR to assess recruitment at an individual trial level. Majority of respondents (63%) had mixed opinions about aggregating metric results across the CTSA Consortium for comparison or benchmarking. Collecting data about additional contextual factors, and comparing accrual between subgroups, were cited as potentially helping address concerns about aggregation. Significant challenges remain in ensuring that the MAR can be sufficiently useful for collaborative process improvement. We offer recommendations to potentially improve metric usefulness.

Pilot test of an accrual Common Metric for the NIH Clinical and Translational Science Awards (CTSA) Consortium: Metric feasibility and data quality.

Failure to accrue participants into clinical trials incurs economic costs, wastes resources, jeopardizes answering research questions meaningfully, and delays translating research discoveries into improved health. This paper reports the results of a pilot test of the Median Accrual Ratio (MAR) metric developed as a part of the Common Metrics Initiative of the NIH's National Center for Advancing Translational Science (NCATS) Clinical and Translational Science Award (CTSA) Consortium. Using the metric is intended to enhance the ability of the CTSA Consortium and its "hubs" to increase subject accrual into trials within expected timeframes. The pilot test was undertaken at Tufts Clinical and Translational Science Institute (CTSI) with eight CTSA Consortium hubs. We describe the pilot test methods, and results regarding feasibility of collecting metric data and the quality of data that was collected. Participating hubs welcomed the opportunity to assess accrual efforts, but experienced challenges in collecting accrual metric data due to insufficient infrastructure and inconsistent implementation of electronic data systems and lack of uniform data definitions. Also, the metric could not be constructed for all trial designs, particularly those using competitive enrollment strategies. We offer recommendations to address the identified challenges to facilitate progress to broad accrual metric data collection and use.

0857 Factors Associated With Sleep Health Among Middle-aged And Older Adults

Abstract Introduction The concept of Sleep Health (SH) was developed to provide a multidimensional framework consisting of characteristics of sleep that have been closely associated with physical and mental well-being. Identification of key factors associated with SH can identify targets for intervention for its improvement. This study aimed to identify factors related to SH among middle-aged and older adults. Methods A valid Sleep Health Composite Measure was recently developed from the data of the 2014 Core Survey of the Health and Retirement Survey and was used to assess overall SH in middle-aged and older adults. Spearman’s correlations, T-test, and Kruskal-Wallis tests were used to explore the association of SH with age, gender, self-rated health, chronic disease burden, disability, pain, and modifiable lifestyle behaviors (physical activity, smoking, alcohol, sleep medication). Results Our sample included 6,095 adults with mean age of 68 years (SD=10.1; range 50-99 years). The majority were female (59.7%) and white (77%). Correlations showed significant moderate associations between SH and self-rated health (r=.404), sleep medications (r=.390), pain (r=-.315). There were significant but small associations between vigorous activity (r=-.193), alcohol (r=.112), currently smoking (r=-.089) and SH. SH was significantly worse among women compared to men (t(6093)=6.996, p<0.001). Furthermore, SH scores were significantly different between middle-aged versus older adults (p<0.001); varying levels of self-rated health (p<0.001), number of chronic diseases (p<0.001), and degree of physical disability (p<0.001). Conclusion These findings provide evidence of factors related to SH among middle-aged and older adults, providing targets for intervention to improve health in this population. Age-related differences in relation to SH indicate intervention tailored for middle-aged adults may improve health outcomes as they age. Future studies are warranted to extend these findings using multivariable statistical approaches. Support This study was supported by the University at Buffalo Clinical and Translational Science Institute (CTSI) funded by the National Institutes of Health (Lorenz PI).

0854 Exploration Of Sleep Health Among Middle-aged And Older Adults

Abstract Introduction Sleep health, a construct introduced to characterize the multidimensional attributes of sleep, has been explored in a variety of populations; however has not been adequately examined for middle-aged and older adults. As attributes of sleep may change with age, the dimensional structure of sleep health may differ in this population. This study aimed to validate a composite measure of sleep health among middle-aged and older adults using data from the Health and Retirement Survey (HRS). Methods Data from the 2014 Core survey of the HRS was used to create a composite measure of Sleep Health including sleep efficiency, duration, timing, satisfaction, and alertness. We standardized and averaged the original variables before transforming to T scores. Sleep Health T scores (ranging 0-100, higher scores indicating better sleep health) were examined using exploratory and confirmatory factor analysis (EFA; CFA). Results Our sample included 6,095 adults with mean age of 68 years (SD=10.1; range 50-99 years). The majority were female (59.7%), white (77%), with high school education (53.9%). Sleep Health T scores ranged from 27-61 (mean=50; SD=6.7). EFA identified one factor. Timing was removed due to low factor loading (<0.4). The revised four-dimension composite Sleep Health measure had acceptable reliability (Cronbach’s alpha 0.6). CFA showed a well-adjusted model (REMSA=0.097; NFI=0.964; RMR=0.035; GFI=0.990; AGFI=0.951). Conclusion These results suggest that the composite measure was valid for assessing sleep health among middle-aged and older adults. Limitations include the use of secondary data, as sleep health dimensions were based on variables not created specifically for our research question. Future research should further examine the role of sleep timing in overall sleep health among middle-aged and older adults. Support This study was supported by the University at Buffalo Clinical and Translational Science Institute (CTSI) funded by the National Institutes of Health (Lorenz, PI).

Translating research into practice: Protocol for a community-engaged, stepped wedge randomized trial to reduce disparities in breast cancer treatment through a regional patient navigation collaborative

BackgroundRacial and socioeconomic disparities in breast cancer mortality persist. In Boston, MA, Black, Non-Hispanic women and Medicaid-insured individuals are 2–3 times more likely to have delays in treatment compared to White or privately insured women. While evidence-based care coordination strategies for reducing delays exist, they are not systematically implemented across healthcare settings. MethodsTranslating Research Into Practice (TRIP) utilizes community engaged research methods to address breast cancer care delivery disparities. Four Massachusetts Clinical and Translational Science Institute (CTSI) hubs collaborated with the Boston Breast Cancer Equity Coalition (The Coalition) to implement an evidence-based care coordination intervention for Boston residents at risk for delays in breast cancer care. The Coalition used a community-driven process to define the problem of care delivery disparities, identify the target population, and develop a rigorous pragmatic approach. We chose a cluster-randomized, stepped-wedge hybrid type I effectiveness-implementation study design. The intervention implements three evidence-based strategies: patient navigation services, a shared patient registry for use across academic medical centers, and a web-based social determinants of health platform to identify and address barriers to care. Primary clinical outcomes include time to first treatment and receipt of guideline-concordant treatment, which are captured through electronic health records abstraction. We will use mixed methods to collect the secondary implementation outcomes of acceptability, adoption/penetration, fidelity, sustainability and cost. ConclusionTRIP utilizes an innovative community-driven research strategy, focused on interdisciplinary collaborations, to design and implement a translational science study that aims to more efficiently integrate proven health services interventions into clinical practice.

A CTSA-based consultation service to advance research on special and underserved populations

In this report, we describe the implementation and short-term outcomes of a Special Populations Consultation Service within the University of California, Los Angeles (UCLA) Clinical and Translational Science Institute (CTSI). With the goal of increasing the quality and quantity of special population (SP) research, the UCLA CTSI Integrating Special Populations program designed a consultation service to support faculty and trainees conducting research involving one of three CTSI "special populations:" children, older adults, and/or minority; underserved; or health disparity populations. The Special Populations Consultation Service offers three types of activities: grant proposal studios, career consultations, and project reviews. UCLA CTSI faculty with appropriate content expertise serve as consultants. We evaluated this consultation model using satisfaction surveys and by quantifying funded grants and reported changes in career goals in SP research. Between 2016 and 2019, the Special Populations Consultation Service provided 59 consultations including 42 grant studios and was used by researchers at all levels from all four UCLA CTSI institutions. Recipients rated the consultations very highly. Funding success rates were 57% following K-level grant studios and 28% following R-level grant studios. Users of project and career consultations commonly attributed career accomplishments in part to their consultation experiences. The SP Consultation Service is feasible and acceptable and appears to enhance careers of investigators studying special populations.

3403 Understanding the career pathways of scholars participating in Scholar Programs and Academy

OBJECTIVES/SPECIFIC AIMS: The Wake Forest Clinical and Translational Science Institute (CTSI) put in place a KL2 program in 2007 and introduced an 18-month Translational Research Academy (TRA) in 2010. The TRA provides education and leadership development training, research support services, mentoring, and networking opportunities to 15-20 early-career clinical and translational researchers, including those receiving KL2 awards. The KL2 and TRA programs make up the Mentored-Career Development Core that is administered by the Wake Forest CTSA Education Program. Over the years, the program administrators have collected feedback from the graduates on what they liked and did not like about the programs. However, a comprehensive evaluation to understand the impact of the trainings on helping scholars advance their research and their research careers was not conducted. The purpose of this evaluation was to assess if and how the KL2 and TRA programs are helping scholars advance their research and career in research. METHODS/STUDY POPULATION: Semi-structured phone interviews were conducted with 11 selected CTSI scholars from both KL2 and TRA programs. The interviews focused on 4 key areas: expectations coming into the program, role the program played in their career development over time, what else could/should have program done to support them and their research, and which of the other CTSI services were valuable in their career development. RESULTS/ANTICIPATED RESULTS: Even though scholars joined the program as an early-career researcher, the amount of experience in research they had varied and so did their areas of interest. The participants in the program also included both clinician and basic researchers. Scholars came into the program with different level of expectations and drive to use this program as a platform to lift their research careers. The conversations during these interviews gave an insight on career trajectories that the scholars have taken before and after joining the academy. For example, among the scholars that had graduated from the programs, 5 of the 6 had received a career development award, all 6 had their own grants to support their research, 3 had received professional promotions, and all 6 have an administrative leadership role they play, in addition to focusing on their research career. The information on where the scholars were at the beginning and the pathway they have taken to get to where they are now allowed us to better understand what aspects of the program was most valuable. The scholars noted that sessions around grant writing and developing specific aims were very helpful. Among the services provided, having a grant editor support was something that everyone noted as the most important service to them, even after leaving the program. DISCUSSION/SIGNIFICANCE OF IMPACT: The impact of the interviews and candid feedback provided by the scholars have been immensely valuable to program administrators to really understand the impact the program (and which components specifically) is having for the scholars. Looking at the career trajectories of the scholars, it was noted that scholars coming in to the academy with some experience doing research and ability to continue engaging in research benefited the most from what the program had to offer. Scholars that were still very early in their research career gained knowledge but were not always able to apply it because they were not working towards a grant at the time. Using the data on career trajectories, recommendations for improving the program, and other CTSI services that were most valuable, the program administrators decided to redesign the curriculum. The new version of the program is now tailored for scholars who have research experience and are working towards a career development grant such as a K or R. This will allow them to have a curriculum that is more intense and hands-on with an expectation that the scholars will submit the application towards the end of the program. A separate program is being developed for early-career researchers who are still setting their foot into t field to provide them basic research competencies through ad hoc courses and seminars.

2360 Engaging, capturing, and integrating the voice of the customer and collaborator in a clinical and translational science program

2360 Engaging, capturing, and integrating the voice of the customer and collaborator in a clinical and translational science program

2178 Drug development core facilitates institutional collaboration and translational science innovation

OBJECTIVES/SPECIFIC AIMS: Drug development is a common research pursuit for basic and clinical scientists that interfaces diagnostic/therapeutic challenges with funding agencies, pharmaceutical industry, regulatory systems, and education. The University at Buffalo Clinical and Translational Science Institute (CTSI) has implemented a Drug Development Core (DDC) with goals that foster team science and collaboration, optimize laboratory use, and networks investigators. Our goals are to foster collaborations within the region and with other CTSAs. METHODS/STUDY POPULATION: The DDC met with 300 potential investigators from 14 departments and several local companies. There were 35 portal requests from 15 departments and 7 companies; 8 were from training programs. For 28 requests, a reviewer provided consultation, while 7 required discussions and review of data. DDC assisted with 15 grant applications (outcomes pending), 10 industry-related new drug development requests and 1 regulatory review. Curriculum reviews noted overlap and gaps. Cross-institute opportunities for M.D.-Ph.D. research mentoring were identified. RESULTS/ANTICIPATED RESULTS: The DDC met with 300 potential investigators from 14 departments and several local companies. There were 35 portal requests from 15 departments and 7 companies; 8 were from training programs. For 28 requests, a reviewer provided consultation, while 7 required discussions and review of data. DDC assisted with 15 grant applications (outcomes pending), 10 industry-related new drug development requests and 1 regulatory review. Curriculum reviews noted overlap and gaps. Cross-institute opportunities for M.D.-Ph.D. research mentoring were identified. DISCUSSION/SIGNIFICANCE OF IMPACT: The CTSI DDC was well received by investigators. The request process fosters collaboration among researchers with similar interests and identifies core laboratory resources that add innovation to ongoing research, funding applications, education, and interinstitutional planning.

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OBJECTIVES/SPECIFIC AIMS: Due to scope and breadth of research activity and infrastructure capacities at academic medical centers, the discipline of Biomedical Informatics is often deployed in a decentralized manner through geographically dispersed and unrelated organizational units. As a result, without a conscious strategy, an academic medical center risks redundant effort and gaps in resources, and perhaps poor coordination. A mechanism to bring together disparate organizational entities to identify, discuss, and negotiate Informatics-related concerns may produce a better institutional research environment. The University of Rochester (UR) has implemented such a strategy of Informatics governance, adapting tactics from team science, diplomacy, and deliberative engagement. METHODS/STUDY POPULATION: Based on current needs and institutional Informatics priorities, the UR’s Clinical and Translational Science Institute (CTSI) established 6 Informatics “clusters” in distinct but deliberately overlapping focal areas: (1) Data—capture, management, and analysis of all types of data for research. (2) Analytics—quantitative research across the spectrum of translational research. (3) Infrastructure—technical and computing infrastructure to support informatics. (4) Electronic health records (EHR)—(i) features within the EHR explicitly designed to address the needs of research; (ii) accessing and procuring EHR data for research. (5) Population health—Informatics design and systems expertise relevant to population health research (a key CTSI focus area). (6) Education—development, deployment, and assessment of Informatics learning opportunities for learners at all levels. Each cluster facilitates access to expertise and resources around the institution, promotes collaboration, identifies redundancy, and serves as a forum to strategize regarding institutional needs related to Biomedical Informatics. A CTSI faculty or staff member leads each cluster. To maximize effectiveness of the cluster, other members are decision-makers in the organizations they represent, or serve in a critical staff function. Clusters meet in person on a quarterly basis with more frequent electronic interaction. The clusters share documents via Box, a secure online file sharing app. The cluster coordinators meet as a group on a biweekly basis to monitor progress and make plans. RESULTS/ANTICIPATED RESULTS: There were 45 different people representing 46 distinct centers, departments or offices, and 2 outside agencies agreed to participate in the clusters. In total, 20 people represented a single organizational unit; 15 represented 2 units; 8 represented 3 units, and 2 represented 4 units. The richness and complexity of these organizational linkages illustrates the decentralized nature of Informatics at the institution and the promise of the cluster approach. DISCUSSION/SIGNIFICANCE OF IMPACT: Adapting to a decentralized Informatics environment, the CTSI established clusters that recognize and respect autonomy and capacity of a wide range of units throughout the university, creating a collaborative atmosphere for steering and implementing an overall Informatics vision. As Informatics capacity rapidly expands throughout growing biomedical research institutions without a centralized Informatics hub, this distributed, deliberative approach could offer an effective governance solution that promotes cooperation. In this model, the CTSI provides the leadership and staffing necessary to ensure progress at the institutional level around Informatics and creates a venue for communication and coordination on Informatics-related topics.

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OBJECTIVES/SPECIFIC AIMS: The objective of this partnership was to create a global network of clinical and public health researchers and communities conducting technology-assisted research in noncommunicable disease. METHODS/STUDY POPULATION: The University of Rochester’s Clinical and Translational Science Institute (CTSI) has successfully leveraged the informatics core’s capacity into an emerging network of organizations that focus on technology and health in settings outside of the mainland United States. The CTSI coordinated with another NIH-funded infrastructure program [the RCMI Translational Research Network (RTRN)] to identify partner institutions interested in technology and health. RTRN identified the University of Puerto Rico and the University of Hawaii, both of which serve as hubs for common research interests in technology and health throughout the Caribbean and the Pacific. This network was formalized as the CDC’s Coordinating Center for its Global and Territorial Health Research Network (the “Global Network”), with additional US partners (Yale, University of Illinois at Chicago, University of North Caroline Chapel Hill, and the University of South Florida) within a wider scope of the CDC’s Prevention Research Centers (PRC) program. RESULTS/ANTICIPATED RESULTS: Through combining 2 main NIH-funded research infrastructure networks (CTSA and RTRN), with a large CDC-funded PRC, the University of Rochester’s Informatics Core was successful in establishing a new productive global health network throughout Latin America and the Caribbean, and in the Pacific, garnering additional research support from NIH Fogarty and other programs. The resulting network not only supports locally-important research in technology and health on compelling health issues (eg, diabetes, ZIka, participation in research), but also facilitates community engagement through local partnerships and the cores of the involved networks. In addition, much of the information and communications technology (ICT)-related research and learnings from the Global Network activity is immediately applicable to populations in the United States, served by the various collaborative networks. In total, while new, the Global Network supports a wide range of projects and engagements throughout the world that expand local informatics capacity and use of technology in the research process and to address global health problems, further enhancing the CTSI’s informatics core to serve the needs of its own constituency and promote research engagement with technology within this population. Local research collaborative projects reinforce the utility of the network and its resources, evidenced by tools, publications, partnerships, and conference presentations that have arisen. Lessons to date from this Global Network collaboration include: specific global research projects provide opportunities for partnership building and meaningful collaboration, team science is of central importance in distributing the work of the network, synergy is multidirectional with expertise and need flowing in all directions, and project team members in all locales learned and contributed substantially in ways that carried into their other responsibilities. DISCUSSION/SIGNIFICANCE OF IMPACT: The overall partnership has created opportunity for South-South collaboration, for adaptation of projects among locales, and has helped boost reputational value for all partners involved. Implications for other CTSA awardees include: global collaboration can serve core research and technical needs for the CTSA itself and its local partners, CTSA status can be leveraged to access resources to support local research, and collaboration in other federally-funded research networks helps expand the insight, scope, and potential for new research.