Browsing by Subject "Indiana CTSI"

Now showing 1 - 6 of 6
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    4255 Indiana Clinical and Translational Sciences Institute (CTSI) – CTSA-wide podcast opportunity
    (Cambridge University Press, 2020-07-29) Drury, Christine; Carroll, Aaron E.; Indiana Clinical and Translational Sciences Institute
    OBJECTIVES/GOALS: The podcasts highlight work from our partners: Indiana University, Purdue University and the University of Notre Dame. Our goal is to expand our podcast reach to include work from at least three additional CTSAs, as well as highlighting the benefits of translational research to the public. METHODS/STUDY POPULATION: Aaron E. Carroll, is the director of Education and Workforce Development for the Indiana CTSI and a popular writer covering health, research, and policy for The New York Times. He is host of the Indiana CTSI-sponsored Healthcare Triage podcasts as well as the Healthcare Triage YouTube show, with 340,000 subscribers. We will leverage his audience and research expertise to grow the Indiana CTSI podcast participation and increase audience engagement. We will eventually allow the nation-wide network of CTSAs to pitch guests and shows covering Translational Research, and invite local CTSA leadership or faculty to participate in the podcast. RESULTS/ANTICIPATED RESULTS: Utilizing quantitative analytics, we expect to see a significant increase in podcast downloads and listeners as we expand our offering to other CTSAs, beyond Indiana We expect that the CTSA-wide podcast will increase the nationwide level of knowledge and understanding of NCATS, translational research, and its benefits to society and healthcare. We anticipate, through this expanded podcast offering, a growing number of community members who are informed and engaged on the topics of translational research, clinical and translational sciences and beyond. DISCUSSION/SIGNIFICANCE OF IMPACT: Podcasts are a convenient, portable, and efficient form of science communication. Podcasts also make information personal and offer us an excellent and innovative communications vehicle to spread the word about translational research, as well as the excellent work happening at each of our CTSAs.
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    472 Indiana CTSI Think Tank Program
    (Cambridge University Press, 2022) Garcia, Kara; Portonovo, Padma; Garci, Kara; Medicine, School of Medicine
    OBJECTIVES/GOALS: The Think Tanks’ aim to assist faculty innovators along the path from discovery to commercialization; serving as a one-stop-shop where investigators can access advice, pilot funds, and direction toward other available resources within the Indiana CTSI. METHODS/STUDY POPULATION: Faculty receive guidance from a pool of advisors in the drug and device industry, as well as their respective university commercialization offices; who serve as an essential resource for a wide range of scientific, technical, clinical, business, and regulatory questions. Investigators submit a simple intake form to connect with a project facilitator for detailed guidance prior to formal meetings. Projects are guided from start to finish with robust tracking and milestone-based funding to help generate data for Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications. Project tracking is conducted using REDCap, which is used for all investigator submissions, with internal processes also tracked in REDCap. RESULTS/ANTICIPATED RESULTS: From Feb-Aug 2021; the Think Tanks provided feedback to 15 drug projects and 6 medical device projects. This included 12 from Indiana University; 4 from Purdue University; and 5 from the University of Notre Dame. Interestingly; drug innovations were submitted primarily by tenure track faculty (100%) with a history of NIH/NSF funding (50%); while device innovations were submitted primarily by clinical faculty without a history of NIH/NSF funding (66%). Based on first-round feedback, a total of approximately $3;400 in pilot funds were provided. Efforts are underway to obtain survey-based feedback from all applicants to date; which will be used to inform future program modifications. DISCUSSION/SIGNIFICANCE: The budding “Think Tank” program provides faculty with a broad perspective of the entire drug and medical device development process, helping investigators understand the critical interplay development stages. Future work seeks to enhance faculty engagement in, and understanding of the commercialization process across Indiana CTSI institutions.
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    509 Regulatory Lens of a QA/QC Project Manager
    (Cambridge University Press, 2024-04-03) Bennett, Rachel; Caldwell, Christine Sego; Medicine, School of Medicine
    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.
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    522 Recruitment Optimization: A Strategic Approach to Integrating Recruitment Services through a Coordinated Multidisciplinary Team
    (Cambridge University Press, 2022) Hudson, Brenda L.; Claxton, Gina; Egan, Carmel; Hardwick, Emily; Shwery, Michelle; Bork, Jason; Amin, Waqas; Anderson, Angela; Wiehe, Sarah; Moe, Sharon; Medicine, School of Medicine
    OBJECTIVES/GOALS: Provide recruitment support via a coordinated application of strategic operations, participant engagement practices, and informatic capabilities best practices. Improve study success through the discovery of optimal recruitment practices, development of needed services, leverage of existing resources, infrastructure and guidance. METHODS/STUDY POPULATION: The optimization effort utilized a variety of methods for engaging participants and obtaining information related to the recruitment needs of study teams. Information was collected from an advisory board and through surveys of a diverse group of investigators and research coordinators examining recruitment barriers as well as current and possible future recruitment services. A workflow of the investigative teams recruitment experience was created to identify strengths, gaps and areas for improvement. This information was used to develop a set of recommendations for the Indiana CTSI leadership. Three pillars were tasked with tackling specific areas through an integrative and collaborative approach: (1) study planning and operations, (2) informatics, and (3) participant engagement and health literacy. RESULTS/ANTICIPATED RESULTS: Key resulting recommendations included: creating a recruitment navigator to direct clients to the most appropriate service(s), adding a community engaged staff member and a digital public engagement specialist to the recruitment services team, redesigning the website navigations, creating participant payment guidelines, creating participant engagement principles guidelines, improving informatics support, and continual evaluation of best practices and innovations in recruitment support. An intake and follow-up survey were created for clients to assess services offered, those used, and ultimately the success of those services in improving recruitment measures. DISCUSSION/SIGNIFICANCE: The optimization efforts have shown a positive response from study teams demonstrated by an uptick of support requests. By taking an intensive strategic planning approach to streamlining recruitment services, the Indiana CTSI has leveraged existing resources to better serve clients in need of critical recruitment assistance.
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    Cross-institutional collaborations for health equity research at a CTSA
    (2022-04-20) Whipple, Elizabeth C.; Ramirez, Mirian; Dolan, Levi; Hunt, Joe D.
    Objective/Goals: We were interested in health equity research for each CTSA-affiliated institution, specifically focusing on cross department and cross-campus co-authorship. We conducted a bibliometric analysis of our CTSA-funded papers relating to diversity and inclusion to identify cross department and cross-campus collaborations. Methods/Study Population: We worked with our CTSA’s Racial Justice, Diversity, Equity and Inclusion Task Force to conduct an environmental scan of diversity and inclusion research across our CTSA partner institutions. Using the Scopus database, searches were constructed to identify and retrieve the variety of affiliations for each of the CTSA authors, a health equity/health disparities search hedge, and all of our CTSA grant numbers. We limited the dates from the beginning of our CTSA in 2008-November 2021. We used PubMed to retrieve all MeSH terms for the articles. We used Excel to analyze the data, Python and NCBI’s Entrez Programming Utilities to analyze MeSH terms, and VOSviewer to produce the visualizations. Results/Anticipated Results: The results of this search yielded 94 articles overall. We broke these up into subsets (not mutually exclusive) to represent five of the researcher groups across our CTSA. We analyzed the overall dataset for citation count, normalized citation count, CTSA average authors, gender trends, and co-term analysis. We also developed cross department co-authorship maps and cross-institutional/group co-authorship maps. Discussion/Significance of Impact: This poster will demonstrate both the current areas where cross-departmental and cross-institutional collaboration exists among our CTSA authors, as well as identify potential existing areas for collaboration to occur. These findings may determine areas our CTSA can support to improve institutional performance in addressing health equity.
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    Project Development Teams in the Indiana CTSI: A resource for investigators
    (Office of the Vice Chancellor for Research, 2011-04-08) Sajdyk, T.J.; Denne, S.
    The Project Development Team (PDT) program is a unique pilot project program found only at the Indiana CTSI. A PDT is a committee of multidisciplinary researchers who assist investigators in developing ideas/hypotheses into well-designed translational research projects. The teams serve as “one stop shops” by providing investigators access to protocol development; pilot funding; biostatistics; IRB/regulatory and nursing support; facilitation of collaboration with other investigators and access to Core Resources on the IUPUI, IU, Purdue and Notre Dame campuses, all in one meeting. There are currently seven PDTs within the Indiana CTSI.