Search

OBJECTIVES/GOALS: The Stanford CTSA Program has started to create Clinical Research Units (CRUs) with the goal to establish CRUs in all clinical departments by the end of 2020. CRUs will be responsible for managing the portfolio of projects proposed and conducted by faculty within departments. CRUs will be responsible for reviewing all clinical research studies. METHODS/STUDY POPULATION: CRUs will be an integral part of the Stanford’s research infrastructure, tasked with 5 key functions to ensure clinical research conducted by Stanford investigators: scientific merit, feasibility, funding, compliance, progress. Each CRU will review all clinical research projects proposed by investigators within the department prior to moving forward with IRB review. Studies will be evaluated annually to ensure compliance with the protocol, applicable laws and regulations, and recruitment goals. The Stanford CTSA will provide guidelines, SOPs and personnel to assist CRUs. In fall 2019, a landscape analysis of SoM clinical departments was conducted to identify: 1)similar existing CRU-like systems,2)unique needs of departments/divisions for developing CRUs and3)barriers to implementation.RESULTS/ANTICIPATED RESULTS: Challenges the pilot CRU has faced include communication and concerns regarding additional obstacles to conducting research. However, as study teams moved through the initial CRU formation, the feedback was overwhelmingly positive. Study teams were appreciative of the constructive feedback and the support for setting up studies. Results from the landscape analysis identified CRU-like systems in 5 departments and highlighted concerns regarding resources needed to implement CRUs. Based on feedback from the landscape analysis, a faculty and operational lead was identified in each clinical department to oversee CRU implementation. Facilitated by CTSA personnel, CRU leads have met quarterly since April 2019. Meetings consist of discussing expectations, sharing ideas and identifying potential roadblocks. DISCUSSION/SIGNIFICANCE OF IMPACT: CRUs will constitute a new organizational structure that consists of teams of investigators and staff to promote high quality, efficient clinical research and enhance collaborative opportunities. The CRU leadership will champion new initiatives in CTR and create pathways for investigators to access research infrastructure and resources. CONFLICT OF INTEREST DESCRIPTION: NA.

In 2017 the American College of Cardiology issued an Expert Consensus Decision Pathway dedicated specifically to the management of bleeding in patients on anticoagulants. The consensus document is both timely and important as indications for more novel anticoagulants expand rapidly. The document reviews in detail recommendations for interruption, management and re-initiation of anticoagulation in bleeding scenarios. Numerous points within the document are relevant to perioperative physicians managing patients on anticoagulation with either bleeding complications or undergoing surgical procedures. The intent of this narrative review is to highlight the salient points within the expert consensus for perioperative physicians.

OBJECTIVES/SPECIFIC AIMS: Engaging patients and consumers in research is a complex process where innovative strategies are needed to effectively translate scientific discoveries into improvements in the public’s health (Wilkins et. al., 2013; Terry et. al., 2013). The Clinical Translational Science Awards (CTSA)—supported by the National Institute of Health (NIH) under the auspices of the National Center for Advancing Translational Sciences (NCATS)—aim to provide resources and support needed to strengthen our nation’s clinical and translational research (CTR) enterprise. In 2008, Stanford University was awarded a CTSA from the NIH, establishing Spectrum (Stanford Center for Clinical and Translational Research and Education) and its Community Engagement (CE) Program aimed at building long-standing community-academic research partnerships for translational research in the local area surrounding Stanford University. To date, the CE Pilot Program has funded 38 pilot projects from the 2009-2017 calendar year. The purpose of this study was to understand, through a unique pilot program, the barriers, challenges, and facilitators to community-engaged research targeting health disparities as well as community-academic partnerships. METHODS/STUDY POPULATION: Investigators conducted a qualitative study of the community engagement pilot program. Previous pilot awardees were recruited via email and phone to participate in a one-hour focus group to discuss their pilot project experience—describing any barriers, challenges, and facilitators to implementing their pilot project. RESULTS/ANTICIPATED RESULTS: The focus group revealed that community engage research through the pilot program was not only appreciated by faculty, but projects were successful, and partnerships developed were sustained after funding. Specifically, the pilot program has seen success in both traditional and capacity building metrics: the initial investment of $652,250.00 to fund 38 projects has led to over $11 million dollars in additional grant funding. In addition, pilot funding has led to peer-reviewed publications, data resources for theses and dissertations, local and national presentations/news articles, programmatic innovation, and community-level impact. Challenges and barriers were mainly related to timing, grant constraints, and university administrative processes. DISCUSSION/SIGNIFICANCE OF IMPACT: The Community Engagement Pilot Program demonstrates an innovative collaborative approach to support community-academic partnerships. This assessment highlights the value and importance of pilot program to increase community engaged research targeting health disparities. Challenges are mainly administrative in nature: pilot awardees mentioned difficulties working on university quarterly timelines, challenges of subcontracting or sharing money with community partners, onerous NIH prior approval process, and limitations to carryover funding. However, pilot grants administered through the program strengthen the capacity to develop larger scale community-based research initiatives.

OBJECTIVES/SPECIFIC AIMS: Helping researchers assess and effectively translate innovations into healthcare improvements is a complex process (Terry et. al., 2013). The Clinical Translational Science Awards (CTSA)—supported by the National Institute of Health (NIH) under the auspices of the National Center for Advancing Translational Sciences (NCATS)— provide the resources and support needed to strengthen our nation’s clinical and translational research (CTR) enterprise. In 2008, Stanford University was awarded a CTSA from the NIH, establishing Spectrum (the Stanford Center for Clinical and Translational Research and Education). Under the Spectrum umbrella, the Byers Center for Biodesign manages the MedTech Pilot Program with the goal of translating discoveries into novel health technologies that address important unmet health needs. The MedTech Pilot Program is an innovative funding mechanism that seeks to (1) stimulate clinical translational research, (2) help promising projects bridge the gap between the bench and the patients’ bedside, and (3) encourage collaborative, transdisciplinary work. Specifically, the Pilot Program offers up to $50,000 to support projects involving medical devices and mobile technologies used for (1) therapeutic applications and (2) device-based patient-specific (or POC) diagnostic applications. This analysis of the MedTech Pilot Program will: 1) describe the Program’s structure and process; 2) highlight the intensive, hands-on mentorship and practical guidance awardees receive that enables them to more efficiently and effectively advance their projects toward patient care; and 3) characterize the progress of the 36 funded projects. METHODS/STUDY POPULATION: Key elements of the Pilot Program’s infrastructure and mentoring processes as they relate to project outcomes were identified. Additionally, outcomes data were collected from two sources: (1) annual survey of Pilot Awardees and (2) publicly available information relevant to the pilot projects. RESULTS/ANTICIPATED RESULTS: The Pilot Program’s framework and infrastructure has supported a diverse group of transdisciplinary projects. These projects were evaluated using both traditional and non-traditional metrics (e.g., patents, startups, publications). The initial investment of $1.5 million to fund 36 projects has led to over $88 million dollars in additional funding. Additionally, taking full advantage of the expertise in Silicon Valley, strong mentorship has helped advance projects along the clinical and translational path. DISCUSSION/SIGNIFICANCE OF IMPACT: The Pilot Program has benefited Stanford innovators and researchers by providing seed funding to help promising projects bridge the gap between the bench and the bedside. The intensive, hands-on mentorship, early pilot funding, and practical guidance pilot awardees receive effectively help translate their technologies into patient care.

Indigenous cultural festivals are increasingly being recognized for their contribution to the growth and vitality of communities around the globe. Such festivals invigorate the communication and celebration of indigenous culture, tradition, and rituals. Additionally, indigenous cultural festivals are often used as a draw card to attract tourists to a host destination and contribute to the development of the region. In Papua New Guinea (PNG), festivals have long been essential to community life and are fundamental in sharing and sustaining Indigenous culture. More recently, local communities and the PNG Government alike are recognizing that these festivals have the capacity to facilitate development of the country's embryonic tourism and event industry. The purpose of this qualitative research was to identify and examine cultural festivals in PNG, to develop a footprint of indigenous cultural festivals in PNG, and explore the extent to which tourism influences the cultural commodification of indigenous cultural festivals in PNG. Weaver and Lawton's cultural commodification model provided theoretical scaffolding for the development of the PNG Indigenous Festival Cultural Commodification Framework, which revealed that overall, cultural festivals in PNG are a relatively unspoiled resource. To date, tourism has had little influence on the festivals, which celebrate, among other things, PNG culture and traditions. However as tourism in PNG gains momentum, arguably a key issue will be the extent to which tourism development adopts the principles of sustainability and, concomitantly, avoids turning a triumph into a tragedy as a result of over commodification of PNG indigenous cultural festivals.

OBJECTIVES/SPECIFIC AIMS: The Clinical Research Operations Program is a free educational program designed to educate clinical research personnel on the conduct of clinical research (CR). The participant completes 16 required core sessions (24 h), 4 elective sessions (4 h), and passes the final exam to receive a certification in CR operations at Stanford. Sessions focus on the 9 domains of CR (established by the Joint Task Force for Clinical Trial Competency), such as Ethical & Participant Safety Considerations, Clinical Study Operations, & Data Management/Informatics. METHODS/STUDY POPULATION: Sessions are taught by volunteer lecturers. Participants may also attend the sessions without pursuing the certification. The program objective is to provide easy-access education in CR in order to increase regulatory compliance, staff retention, and improve CR at Stanford. The program targets CR coordinators, however, staff, postdocs, fellows, and faculty also participate. RESULTS/ANTICIPATED RESULTS: Since the program’s launch in January 2017, 119 individuals have enrolled in the certification program. The most represented group is the Department of Medicine. Sessions consistently reach their maximum with a waiting list. Each core session requires that the participant complete an evaluation (Likert scale, 1–5) of the registration process (4.5/5), the class environment (4.6/5), the presented content (4.5/5), and the instructor (4.6/5). Data from these evaluations are positive to date and is used to continually refine the program. DISCUSSION/SIGNIFICANCE OF IMPACT: N/A.

OBJECTIVES/SPECIFIC AIMS: Dissemination of research findings through the published literature is a complex but critical part of the scholarly communication process. Additionally, this time point on the translational spectrum is a key objective of the National Clinical Association for Advancing Translational Sciences (NCATS). Tracking the dissemination of research outputs can be difficult to identify and evaluate. The purpose of this case study was 2-fold: (1) identify tools and resources available freely to the public and through university subscriptions used to assess research output; and (2) compare the effectiveness of these tools oat tracking output at different levels of granularity. METHODS/STUDY POPULATION: The authors, Spectrum staff (D.A.) and School of Medicine librarian (M.B.), attended webinars hosted by other Academic Medical Center libraries conducting work on impact tracking and learned from vendor product managers about available tools and resources during on-site campus visits. Publications from Stanford’s Clinical and Translational Science Award (CTSA) were used to track the diffusion of research outputs (e.g., number of citations, document types, research areas, relative citation ratio, CTSAs collaboration) via library subscription services (e.g., Web of Science and Scopus) and freely available tools (e.g., iCite and PubMed). RESULTS/ANTICIPATED RESULTS: The authors found certain tools were more inclusive in retrieving grant funded research outputs. For example, in the case of UL1 grant (UL1TR001085, UL1TR000093, UL1RR025744), on a grant-level output, there were discrepancies in the number of publications retrieved: (1) PubMed found 644 outputs; (2) Web of Science found 497 outputs; and (3) Scopus found 190 outputs. After de-duplication, the search across Web of Science (WoS), Scopus, and PubMed yielded 899 publications. In total, 389 outputs were unique to PubMed; 165 were unique to WoS; and 90 were unique to Scopus. Future analysis will be conducted to identify the source of unique outputs from each database (e.g., conference proceeding, specific journals). Additional analysis based on other units of research outputs (e.g., author-level outputs and article-level outputs) are expected to yield similar discrepancies. DISCUSSION/SIGNIFICANCE OF IMPACT: Citation analysis is a valuable method of assessing research output and, to a larger extent, research impact in a given field. It can help investigators illustrate qualifications for undertaking new projects, highlight collaborations across schools and departments, justify a grant renewal, and/or highlight accomplishments for promotion. However, systematic and comprehensive evaluations are needed in tandem with citation analysis/bibliometric analysis to assess the translation and uptake of research outputs and activities that result in research impact. Furthermore, both investigators and staff need adequate time and training to process research outputs/activities and to effectively organize them in easily understood visualizations.

Since the observations in the 1960s that granulocyte-colony stimulating factor (G-CSF) stimulated the proliferation of granulocytic cells in semisolid cultures of bone marrow cells, G-CSF has established itself as a useful clinical agent for increasing levels of neutrophilic granulocytes. However, these early findings did not firmly establish whether G-CSF is a genuine regulator of granulocyte formation under normal physiological conditions or rather acts as an emergency regulator, playing an important role only under stress conditions. The advent ofgene-knockout technologyhas allowed us to evaluate these questions in a physiological setting through analysis of mice with a targeted mutation of G-CSF or its receptor, while the development of relevant cell models has enabled us to dissect the molecular basis of G-CSF action. This review discusses our current state of knowledge regarding the role of G-CSF in granulopoiesis.