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

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.

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4079 Lessons learned from implementing Quality Improvement (QI) in academic clinical research setting

Journal of Clinical and Translational Science ◽

10.1017/cts.2020.241 ◽

2020 ◽

Vol 4 (s1) ◽

pp. 74-74

Author(s):

Chin Chin Lee ◽

DUSHYANTHA JAYAWEERA ◽

Marjorie Godfrey ◽

Matthias Salathe ◽

Jonelle Wright ◽

...

Keyword(s):

Quality Improvement ◽

Clinical Research ◽

Research Unit ◽

Lessons Learned ◽

Research Teams ◽

Team Members ◽

Clinical Research Unit ◽

Study Population ◽

Survey Results ◽

The University

OBJECTIVES/GOALS: We describe here the implementation of a pilot Quality Improvement (QI) program in clinical research processes in order to facilitate translation from bench to community. This presentation will also discuss challenges encountered by the research teams during the implementation of QI activities. METHODS/STUDY POPULATION: Miami CTSI collaborated with University of Kansas’ CTSA to test the implementation of a QI program for clinical research processes. The program has a duration of 1 year and consists of multi-modal training and coaching sessions with different research teams. Six teams comprising of Principal investigators, clinical coordinators, and regulatory specialists participated in the program based in applied clinical microsystem theory science. Team coaches and teams worked together to assess current processes, test new and improved processes, and standardize and disseminate applicable best practices of the QI program. RESULTS/ANTICIPATED RESULTS: The implementation of QI activities in large clinical research settings poses numerous challenges for the research team. We will present survey results from the coaching sessions and follow on feedback from the different teams involved in the program to implement the QI activities. We will describe the modifications and adjustments made to the original conceptual framework of QI program in order for it to be applicable and feasible for the settings of the University of Miami. We will provide recommendations for other academic clinical research centers that are considering implementing a QI program. DISCUSSION/SIGNIFICANCE OF IMPACT: The successful adaptation of a QI process to implement in academic clinical research settings relies on early engagement of the institution leadership, careful selection of team members, as well as developing communication skills to enhance team dynamics as a clinical research unit.

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Potential role of a pharmacist to enhance medication-related aspects of clinical trials conducted in a dedicated clinical research unit

Contemporary Clinical Trials Communications ◽

10.1016/j.conctc.2017.03.003 ◽

2017 ◽

Vol 6 ◽

pp. 55-57 ◽

Cited By ~ 1

Author(s):

Kimberly A. Redic ◽

Amy Skyles ◽

John Zaccardelli

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Potential Role ◽

Research Unit ◽

Clinical Research Unit

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The Clinical Research Unit — A nurse-led unit for cancer patients receiving chemotherapy in phase I clinical trials

European Journal of Cancer ◽

10.1016/s0959-8049(97)86385-x ◽

1997 ◽

Vol 33 ◽

pp. S334

Author(s):

C. Cameron

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Phase I ◽

Cancer Patients ◽

Research Unit ◽

Phase I Clinical Trials ◽

Clinical Research Unit

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C1-2: The Division of Research Comprehensive Clinical Research Unit Pre-Award Process and Budgeting for Clinical Trials

Clinical Medicine & Research ◽

10.3121/cmr.2013.1176.c1-2 ◽

2013 ◽

Vol 11 (3) ◽

pp. 164-164

Author(s):

N. Hock

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Research Unit ◽

Clinical Research Unit

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Comparison of actigraphy and polysomnography to assess effects of zolpidem in a clinical research unit

Sleep Medicine ◽

10.1016/j.sleep.2011.12.003 ◽

2012 ◽

Vol 13 (4) ◽

pp. 419-424 ◽

Cited By ~ 32

Author(s):

Barry T. Peterson ◽

Ping Chiao ◽

Eve Pickering ◽

Jon Freeman ◽

Gary K. Zammit ◽

...

Keyword(s):

Clinical Research ◽

Research Unit ◽

Clinical Research Unit

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The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC): experiences from a successful ERS Clinical Research Collaboration

Breathe ◽

10.1183/20734735.005117 ◽

2017 ◽

Vol 13 (3) ◽

pp. 180-192 ◽

Cited By ~ 17

Author(s):

James D. Chalmers ◽

Megan Crichton ◽

Pieter C. Goeminne ◽

Michael R. Loebinger ◽

Charles Haworth ◽

...

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Research Collaboration ◽

Clinical Care ◽

Research Priorities ◽

Chronic Obstructive ◽

List Type ◽

European Respiratory Society ◽

Obstructive Pulmonary Disease ◽

Research Education

In contrast to airway diseases like chronic obstructive pulmonary disease or asthma, and rare diseases such as cystic fibrosis, there has been little research and few clinical trials in bronchiectasis. Guidelines are primarily based on expert opinion and treatment is challenging because of the heterogeneous nature of the disease.In an effort to address decades of underinvestment in bronchiectasis research, education and clinical care, the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) was established in 2012 as a collaborative pan-European network to bring together bronchiectasis researchers. The European Respiratory Society officially funded EMBARC in 2013 as a Clinical Research Collaboration, providing support and infrastructure to allow the project to grow.EMBARC has now established an international bronchiectasis registry that is active in more than 30 countries both within and outside Europe. Beyond the registry, the network participates in designing and facilitating clinical trials, has set international research priorities, promotes education and has participated in producing the first international bronchiectasis guidelines. This manuscript article the development, structure and achievements of EMBARC from 2012 to 2017.Educational aimsTo understand the role of Clinical Research Collaborations as the major way in which the European Respiratory Society can stimulate clinical research in different disease areasTo understand some of the key features of successful disease registriesTo review key epidemiological, clinical and translational studies of bronchiectasis contributed by the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) project in the past 5 yearsTo understand the key research priorities identified by EMBARC for the next 5 years

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Referrals for panic disorder to a clinical psycho-pharmacology research unit

Psychiatric Bulletin ◽

10.1192/pb.17.7.416 ◽

1993 ◽

Vol 17 (7) ◽

pp. 416-417 ◽

Cited By ~ 3

Author(s):

Luiz Dratcu ◽

Alyson Bond

Keyword(s):

Panic Disorder ◽

Clinical Research ◽

Research Unit ◽

Clinical Population ◽

Constant Flow ◽

Research Projects ◽

Clinical Research Unit

Clinical research attempts to find out the best way to treat patients and audit attempts to make sure that patients are treated in the best possible way. The two are thus inextricably linked and should benefit from each other (Smith, 1992). In running a clinical research unit in which the personnel involved (two psychiatrists and two psychologists) have only honorary contracts, it is sometimes difficult to match the service offered to the clinical population required. A constant flow of patients does not mean a constant flow of those prepared or suitable to participate in research projects. Unlike clinical referrals, which are received passively, referrals of patients for research have to be looked for, even when treatment is on offer.

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