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

2017 ◽  
Vol 6 ◽  
pp. 55-57 ◽  
Author(s):  
Kimberly A. Redic ◽  
Amy Skyles ◽  
John Zaccardelli
2019 ◽  
Vol 3 (s1) ◽  
pp. 135-135
Author(s):  
Leigh Ann Ross ◽  
Christian R. Gomez ◽  
Ingrid C. Espinoza ◽  
Kim G. Adcock ◽  
Lauren S. Bloodworth

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.


2012 ◽  
Vol 13 (4) ◽  
pp. 419-424 ◽  
Author(s):  
Barry T. Peterson ◽  
Ping Chiao ◽  
Eve Pickering ◽  
Jon Freeman ◽  
Gary K. Zammit ◽  
...  

Author(s):  
Elizabeth Biswell R ◽  
Michael Clark ◽  
Michela Tinelli ◽  
Gillian Manthorpe ◽  
Joanne Neale ◽  
...  

1993 ◽  
Vol 17 (7) ◽  
pp. 416-417 ◽  
Author(s):  
Luiz Dratcu ◽  
Alyson Bond

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.


2020 ◽  
Vol 4 (s1) ◽  
pp. 74-74
Author(s):  
Chin Chin Lee ◽  
DUSHYANTHA JAYAWEERA ◽  
Marjorie Godfrey ◽  
Matthias Salathe ◽  
Jonelle Wright ◽  
...  

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.


2015 ◽  
Vol 37 (8) ◽  
pp. e125
Author(s):  
M. Serrano Olmeda ◽  
M. Del Álamo Camuñas ◽  
E. Lorente Páramo ◽  
M. Aguilar Jiménez ◽  
I. De Pablo López de Abechuco ◽  
...  

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