scholarly journals Re-engineering The Clinical Research Enterprise in Response to COVID-19: The Clinical Translational Science Award (CTSA) Experience and Proposed Playbook for Future Pandemics

2021 ◽  
pp. 1-28
Author(s):  
Barry S. Coller ◽  
John B. Buse ◽  
Robert P. Kimberly ◽  
William G. Powderly ◽  
Martin S. Zand
Keyword(s):  
Clinical Research ◽  
Translational Science

scholarly journals 4195 “Learning Shots” are an Innovative, Versatile Educational Tool for Clinical and Translational Science

2020 ◽  
Vol 4 (s1) ◽  
pp. 55-56
Author(s):  
Jean Eby ◽  
Susie Hoffman ◽  
Karen Johnston ◽  
Jennifer Phillips
Keyword(s):  
Clinical Research ◽  
Learning Needs ◽  
Translational Science ◽  
Educational Tool ◽  
University Of Virginia ◽  
Research Information ◽  
Research Environment ◽  
Continuous Evaluation ◽  
Clinical Research Coordinators ◽  
The University

OBJECTIVES/GOALS: To demonstrate how brief online audiovisual presentations, “learning shots”, informed by evaluation, can be used to quickly and effectively provide essential just-in-time research-related education in the complex and evolving world of clinical and translational science. METHODS/STUDY POPULATION: “Learning shots” are an educational tool, originally developed by the University of Virginia IRB for Health Sciences Research, that cover a broad spectrum of methodological, regulatory, and ethical topics in research. They are designed to be responsive to adult learners, a rapidly changing research environment, and the need for flexible offerings. Learning shots target different groups involved in research including clinical research coordinators, investigators, and trainees. A survey was used to assess the role of learning shots in meeting learning needs. Moving forward, continuous evaluation will occur through the addition of tracking and a short evaluation survey to each learning shot. RESULTS/ANTICIPATED RESULTS: The University of Virginia has an online library of over 30 learning shots. Learning shots are used to cover foundational topics (e.g. GCP) as well as more specialized topics (e.g. comparative effectiveness research). They can also be used to quickly respond to breaking issues (e.g. single IRB review). In an initial survey targeting University of Virginia clinical research coordinators, 54 (68%) of 79 respondents reported having viewed a learning shot. Among those who had, 41 (84%) of 49 respondents reported that learning shots were helpful to their learning needs. Continuous evaluation is expected to further inform how learning shots meet clinical and translational science education needs. DISCUSSION/SIGNIFICANCE OF IMPACT: Learning shots are an innovative and versatile educational tool for clinical and translational science that can be used to quickly and effectively convey important research information in response to an increasingly complex research environment and diverse learner needs.

scholarly journals 3392 Tapping into Community Insight and Lived Experience to Inform, Guide and Direct Translational Science Initiatives

2019 ◽  
Vol 3 (s1) ◽  
pp. 95-95
Author(s):  
Miles McNeeley ◽  
Katrina Kubicek ◽  
Lourdes Baezconde-Garbanati ◽  
Karen D. Lincoln ◽  
Michele Kipke
Keyword(s):  
African American ◽  
Los Angeles ◽  
Clinical Research ◽  
Community Engagement ◽  
Community Advisory Board ◽  
Translational Science ◽  
Community Members ◽  
Black African ◽  
African American Communities ◽  
Community Input

OBJECTIVES/SPECIFIC AIMS: This study aims to describe adaptability in methods used to apply community input to programming within the field of translational science. The outcomes of community informed programming include opportunities for innovative projects and approaches, and better responsiveness to community needs. It is anticipated that this will result in greater community involvement in research, moving towards greater health equity. METHODS/STUDY POPULATION: The SC CTSI is situated in urban Los Angeles, one of the most diverse communities in the world. Eight SC CTSI Community Engagement Core initiatives that employ community partnership are illustrated. The activities include social marketing campaigns for cervical cancer prevention; use of community-embedded research ambassadors to increase scientific literacy in Latino and Black/African-American communities; use of innovative technologies to educate pediatric patients and families about clinical research; working with the entertainment industry to promote clinical research in popular television shows; a community advisory board that is tailored and embedded in each CSTA core group; a community based research dissemination program; an ad-hoc community advisory group assembled to adapt a research 101 curriculum for Black/African-American communities; and a series of listening sessions conducted throughout Los Angeles. RESULTS/ANTICIPATED RESULTS: Integration of community voices provide direction for future planning, programming and execution of all referenced initiatives. Ultimately, the goal for these discussions with community members is to develop innovative approaches to CTSA programming. DISCUSSION/SIGNIFICANCE OF IMPACT: Racial and ethnic minorities continue to experience underrepresentation in clinical research trials. CTSAs have been tasked with addressing barriers that have historically led to disparities in research participation, and by extension, the effectiveness of medical interventions in diverse populations. Community input is an invaluable source for knowledge and innovative ideas in how to increase involvement in various aspects of the research process, including dissemination, recruitment and enrollment in clinical trials. CTSAs have increasingly augmented Community Engagement programs within their respective cores to address population disparities. The approaches used to engage communities require an element of fluidity and flexibility, and a reliance on the input of community members, in order to maintain relevant and desired community engagement practices.

scholarly journals 3222 University of Mississippi Center for Clinical and Translational Science (CCTS): A Catalyst for Clinical and Translational Sciences

2019 ◽  
Vol 3 (s1) ◽  
pp. 135-135
Author(s):  
Leigh Ann Ross ◽  
Christian R. Gomez ◽  
Ingrid C. Espinoza ◽  
Kim G. Adcock ◽  
Lauren S. Bloodworth
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Research Collaboration ◽  
Research Unit ◽  
Translational Science ◽  
University Of Mississippi ◽  
Community Population ◽  
Clinical Research Unit ◽  
The University ◽  
Clinical And Translational Research

OBJECTIVES/SPECIFIC AIMS: To introduce CCTS to the clinical and translational research community. METHODS/STUDY POPULATION: Established in the summer of 2017, the Center for Clinical and Translational Science (CCTS) fosters cooperative clinical and translational sciences between the University of Mississippi School of Pharmacy (UMSOP) and the University of Mississippi Medical Center (UMMC). CCTS facilitates the translation of basic research discoveries into clinically validated therapies to improve the health of populations in Mississippi and beyond. Priority areas of investigation in CCTS include Cardiometabolic disorders, Cancer, Neuroscience, Infectious diseases, Precision Medicine, and Community-Based Research. To accomplish CCTS mission three overarching goals have been defined: I) Develop progressive and sustainable capacity for clinical and translational research in Mississippi; II) Promote interprofessional engagement in clinical and translational science; and III) Foster research collaboration among stakeholders in and outside of Mississippi. RESULTS/ANTICIPATED RESULTS: To carry its CCTS’s mission three research units have been established: 1) The Pre-clinical Research Unit: Develops processes to move basic science discoveries towards translation into research in humans. This unit provides guidance in the development of Investigational New Drug (IND) applications; and identifies and pursues opportunities to develop progressive capacities for in vitro, ex vivo, in vivo, and in silico approaches for evaluating new pharmaceutical and therapeutic agents. 2) The Clinical Research Unit: Transitions projects that have received IND approval into the first phase of clinical trials. It also transitions clinical trials from Phase I to Phase II and to Phase III; develops standard operating procedures (SOPs), personnel training plans, and policies to guide clinical research; works with industry sponsors and governmental funding agencies; and assures compliance with regulatory requirements. 3) Community/population Research Unit: Develops, coordinates, and facilitates research activities and translation between clinical and community/population research stages. To do so, this unit works closely with community partners and Population Health programs on the Oxford and Jackson campuses. DISCUSSION/SIGNIFICANCE OF IMPACT: Since its inception, the CCTS has surpassed 1.5 million dollars in competitive funding. This early success positions the CCTS well to promote research collaboration between UMSOP and UMMC and to progress in becoming a national leader in clinical and translational investigation.

scholarly journals A content analysis of Clinical and Translational Science Award (CTSA) strategies for communicating about clinical research participation online

2017 ◽  
Vol 1 (6) ◽  
pp. 340-351 ◽  
Author(s):  
Elizabeth Flood-Grady ◽  
Samantha R. Paige ◽  
Nicki Karimipour ◽  
Paul A. Harris ◽  
Linda B. Cottler ◽  
...  
Keyword(s):  
Content Analysis ◽  
Clinical Research ◽  
Web Sites ◽  
Research Participation ◽  
National Institutes Of Health ◽  
Transactional Model ◽  
Translational Science ◽  
Design Strategies ◽  
Cr Content ◽  
Phone Number

IntroductionThere is a dearth of literature providing guidance on how to effectively communicate about clinical research (CR).MethodsUsing the transactional model of communication, a content analysis of the investigator (n=62) and participant (n=18) Web sites of institutions funded through the National Institutes of Health Clinical and Translational Science Award (CTSA) was conducted to identify their strategies (e.g., messages) for communicating about CR participation.ResultsCTSAs targeted investigators with CR participation content across the main Web sites, although most CTSAs (n=55; 88.7%) also included CR participation content for participants. In total, 18 CTSAs (29%) hosted participant Web sites. Participant sites included 13 message types about CR participation (e.g., registry enrollment) and 5 additional channels (e.g., email, phone number) to communicate about CR. However, many CTSA participant Web sites excluded information explaining the CR process and offered CR content exclusively in English.ConclusionCTSAs should identify their target audience and design strategies (e.g., messages, channels) accordingly.

scholarly journals Creation of an institutional semi-independent data monitoring committee

2019 ◽  
Vol 16 (5) ◽  
pp. 523-530
Author(s):  
Lisa R Tannock ◽  
Marietta Barton-Baxter ◽  
William W Stoops
Keyword(s):  
Clinical Research ◽  
Data Monitoring Committee ◽  
National Institutes Of Health ◽  
Data Monitoring ◽  
Translational Science ◽  
Major Goal ◽  
Regulatory Requirements ◽  
University Of Kentucky ◽  
Monitoring Committee ◽  
The University

Background A major goal of the National Institutes of Health’s Clinical and Translational Science Award program is to facilitate clinical research and enhance the transition of basic to clinical research. As such, a number of Clinical and Translational Science Award centers have developed services to facilitate the conduct of clinical research, including support with fulfilling regulatory requirements. Methods The University of Kentucky sought to establish an institutional semi-independent monitoring committee to provide oversight for clinical research studies per National Institutes of Health requirements and recommendations. Our semi-independent monitoring committee was initiated in 2010. Results Since the inception of our semi-independent monitoring committee we have restructured its operations and protocols to improve efficiency. This article discusses our experiences with semi-independent monitoring committee creation and growth. Conclusion This article summarizes our experience in creating and maturing an institutional data monitoring committee.

scholarly journals Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ): Recommendations for Good Clinical Practice (GCP) training for investigators and study coordinators

2017 ◽  
Vol 1 (1) ◽  
pp. 8-15 ◽  
Author(s):  
Thomas P. Shanley ◽  
Nancy A. Calvin-Naylor ◽  
Ruthvick Divecha ◽  
Michelle M. Wartak ◽  
Karen Blackwell ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Clinical Research ◽  
Behavioral Interventions ◽  
Task Force ◽  
Good Clinical Practice ◽  
Translational Science ◽  
Minimum Criteria ◽  
Research Professionals

IntroductionThe translation of discoveries to drugs, devices, and behavioral interventions requires well-prepared study teams. Execution of clinical trials remains suboptimal due to varied quality in design, execution, analysis, and reporting. A critical impediment is inconsistent, or even absent, competency-based training for clinical trial personnel.MethodsIn 2014, the National Center for Advancing Translational Science (NCATS) funded the project, Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ), aimed at addressing this deficit. The goal was to ensure all personnel are competent to execute clinical trials. A phased structure was utilized.ResultsThis paper focuses on training recommendations in Good Clinical Practice (GCP). Leveraging input from all Clinical and Translational Science Award hubs, the following was recommended to NCATS: all investigators and study coordinators executing a clinical trial should understand GCP principles and undergo training every 3 years, with the training method meeting the minimum criteria identified by the International Conference on Harmonisation GCP.ConclusionsWe anticipate that industry sponsors will acknowledge such training, eliminating redundant training requests. We proposed metrics to be tracked that required further study. A separate task force was composed to define recommendations for metrics to be reported to NCATS.

scholarly journals Core informatics competencies for clinical and translational scientists: what do our customers and collaborators need to know?

2016 ◽  
Vol 23 (4) ◽  
pp. 835-839 ◽  
Author(s):  
Annette L Valenta ◽  
Emma A Meagher ◽  
Umberto Tachinardi ◽  
Justin Starren
Keyword(s):  
Big Data ◽  
Clinical Research ◽  
Biomedical Informatics ◽  
Core Competencies ◽  
Translational Science ◽  
Current Version ◽  
Health Records ◽  
Clinical Research Informatics ◽  
Competency Domains ◽  
Over Time

Abstract Since the inception of the Clinical and Translational Science Award (CTSA) program in 2006, leaders in education across CTSA sites have been developing and updating core competencies for Clinical and Translational Science (CTS) trainees. By 2009, 14 competency domains, including biomedical informatics, had been identified and published. Since that time, the evolution of the CTSA program, changes in the practice of CTS, the rapid adoption of electronic health records (EHRs), the growth of biomedical informatics, the explosion of big data, and the realization that some of the competencies had proven to be difficult to apply in practice have made it clear that the competencies should be updated. This paper describes the process undertaken and puts forth a new set of competencies that has been recently endorsed by the Clinical Research Informatics Workgroup of AMIA. In addition to providing context and background for the current version of the competencies, we hope this will serve as a model for revision of competencies over time.

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