Overview

The University of Louisville has one of the oldest medical schools in the country. It was developed, in part, to provide medical care for riverboat workers on the Ohio River. The university has a long and rich history of educating excellent clinical practitioners, and it has graduated well over half of the practicing physicians in the state of Kentucky.

The university hosts a number of nationally recognized academic programs and is home to some of the nation's top researchers. The medical center is internationally recognized for advances made by its medical school faculty, including the first self-contained artificial heart, the first successful hand transplant and research in cancer, heart disease and stem cells.

The University of Louisville Hospital serves as the primary adult teaching hospital for the school’s faculty, who also practice at the university’s Health Care Outpatient Center. The clinical care provided by this center continues to receive recognition. The hospital is the site of the nation’s first trauma center, whose recent accolades include being named the state’s first certified stroke center and becoming the state’s first nationally accredited breast care center. Helping to serve as a place for translating research advances into treatments and cures are the seven acute care hospitals that comprise the Louisville Medical Center. Each hospital is managed by a not-for-profit organization with a long history of providing compassionate care. Member institutions are Frazier Rehabilitation Center, Jewish Hospital, Norton Children’s Hospital, Norton Hospital, Norton Medical Pavilion, Rudd Heart and Lung Center, and the University of Louisville Hospital. University faculty provide clinical care at each of these facilities

In the heart of downtown Louisville, the center offers the largest concentration of healthcare providers in Kentucky and the region and one of the largest concentrations in the nation. It employs 12,000 healthcare workers and has a half-billion-dollar payroll. It serves more than half a million patients each year from around the globe, who come because of its reputation for leading-edge medical research and breakthrough medical treatments.

Research Experience

• Anesthesiology
• Pain management
• Neurology
• Neurological surgery
• Pediatrics
• Neonatology
• Medicine
• Infectious diseases
• Cardiology/interventional cardiology
• Endocrinology/metabolism
• Gastroenterology/hepatology/nutrition
• Pulmonary/critical care/sleep disorders
• Nephrology
• Rheumatology
• Hematology/oncology
• Dermatology
• Emergency medicine
• Family Practice/Geriatrics
• OB/GYN
• Ophthalmology
• Urology
• General surgery
• Orthopedic surgery
• Pathology/laboratory medicine
• Forensic
• Critical care
• Emergency medicine
• Psychiatry/addiction psychiatry
• Radiation oncology
• Diagnostic radiology
• Dentistry

Please check out our website for information on active trials: University of Louisville, Clinical Trials Unit Outpatient Clinic.

The university has collaborated with the following sponsors/CROs in clinical research:

Facility Description

University of Louisville Clinical Trials Unit Outpatient Research Clinic

The University of Louisville Clinical Trials Unit (CTU) outpatient research clinic is dedicated to promoting and facilitating outpatient clinical research at the university. The unit is centrally located on the downtown medical campus and is easily accessible to research patients and healthcare researchers. The clinic serves all of the medical faculty of the university and offers a centralized, streamlined approach to human subject research. The fully staffed research unit can accommodate most outpatient research studies.

The CTU Outpatient Research Clinic features five fully furnished exam rooms, a four-chair infusion center, phlebotomy station and processing laboratory (CLIA certified). The facility can accommodate all types of research requirements from phase 1 to 4.

Facility Equipment

•  -70°C specimen freezers
•  -20°C specimen freezers
•  -2°C to 8°C specimen refrigerators
•  -2°C to 8°C drug storage refrigerator
•  Refrigerated centrifuges
•  Ambient centrifuges
•  24/7 temperature monitoring/logging
•  InBody 770 body compilation analyzer
•  Oxygen concentrator and bottle fill system
•  Monitor work areas
•  Research drug storage room (temperature-controlled, limited access)
•  Double-lock drug cabinets

There is convenient parking connected to the Outpatient Center via a pedway as well as direct access to the University of Louisville Hospital.

The CTU Outpatient Research Clinic employs two nurse practitioners and five full-time clinical research nurses and coordinators. The professionals in this clinic have an average of 10 years of experience in clinical research. These personnel have education/certifications in the following areas: clinical research coordinator, Bachelor of Nursing, master of nursing and advanced practice research nursing. For specific personnel information, please visit our website.

University of Louisville Physicians is staffed with more than 500 physicians. University Hospital is the region’s preeminent medical teaching and research hospital and plays a key role in ensuring the quality of healthcare in the community. It has developed a robot system for providing scarce specialty care to rural health partners. The hospital operates the area’s only 24-hour Level I trauma and emergency center. Other key specialty services include women’s health, digestive diseases, sleep disorders, bone marrow transplant, stroke center and psychiatry. The James Graham Brown Cancer Center, which is part of University of Louisville Healthcare, is the area’s most comprehensive cancer care research and treatment facility.

Jewish Hospital is a 442-bed regional referral center. The hospital is also the flagship of the KentuckyOne HealthCare Network, a regional network of more than 35 healthcare locations throughout Kentucky and southern Indiana, including the Frazier Rehabilitation Hospital and the Rudd Heart and Lung Center. The network encompasses nearly 1,700 beds and serves more than one million patients annually. Jewish Hospital is an internationally renowned specialty center, developing leading-edge advancements in heart and lung care, hand and microsurgery, rehabilitation medicine, neuroscience, occupational health, organ transplantation, outpatient care, plastic and aesthetic surgery and primary care. It is among the top 10 cardiac centers (by volume) in the U.S. and is a leader in transplantation, performing all five solid organ transplants (heart, liver, lung, kidney and pancreas), as well as hand transplantation.

Frazier Rehab Downtown is a 135-bed hospital located on the Jewish Hospital Medical Campus. Frazier is committed to the development of programs that combine traditional rehab with innovative therapy techniques. The facility stands 15 stories tall and houses world-class, groundbreaking programs, such as the Christopher and Dana Reeve NeuroRecovery Network, the spinal cord medicine program and the locomotor training program. The facility offers therapy gyms located on each floor and patient rooms offer a full spectrum of 24-hour-a-day hospital services, such as lab, x-ray, diagnostic imaging and respiratory therapy. The downtown facility offers both inpatient and outpatient rehabilitation and also offers a fitness and wellness facility designed to help those with disabilities stay fit for life.

Jewish Hospital Heart Care, Rudd Heart and Lung Center, and the Heart & Lung Institute boast the region’s only accredited chest pain center and a rich history of medical innovation and advancement. Offering the most complete range of diagnostic and interventional heart care services available anywhere in the region, Jewish Hospital's ranking and patient outcomes consistently exceed national averages. And Jewish provides a full spectrum of nonsurgical options encompassing cardiac catheterizations, angioplasties, electrophysiology studies, pulmonary function testing and hyperbaric medicine.

Louisville VA Medical Center is an acute care hospital located approximately four miles from the main Medical Center Campus, housing the inpatient population and multiple primary and subspecialty outpatient facilities. Several specialized programs exist at the Louisville VA Hospital, including the regional center for bariatric surgery and home-based primary care providing personal home monitoring and telehealth management of chronic obstructive pulmonary disease, congestive heart failure and diabetes, as well as hospice and palliative care programs.

Norton Healthcare is a not-for-profit organization, operating Norton Hospital, Norton Children’s Hospital and the Norton Healthcare Pavilion in the Louisville Medical Center. It also operates three other hospitals in Louisville, and 16 managed community and rural hospitals in Kentucky, Indiana and Illinois. Norton Healthcare also owns three physician practices and is affiliated with Floyd Memorial Hospital and Health Services in New Albany, Ind.; Southern Indiana Medical Center, Charlestown, Ind.; and Regional Medical Center in Madisonville, Ky.

Norton Healthcare Pavilion, formerly Methodist Evangelical Hospital, has served for more than a century. The people of Louisville and the surrounding region have turned to Norton Healthcare facilities for a full range of medical care. Through one of the area's most comprehensive healthcare networks, Norton Healthcare's integrated system bridges the life span, providing quality care to newborns, children, adults and the elderly.

Norton Children’s Hospital is a not-for-profit children’s hospital operated by Norton Healthcare. Norton has the area’s highest-level neonatal intensive care unit, a children’s burn unit and specialists in all areas of pediatric care. Importantly, it has a pediatric clinical research center focusing on pharmacokinetics and pharmacodynamics of drug metabolism in children. For more information on pediatric clinical trials, please visit: University of Louisville Kosair Charities Pediatric Clinical Research Unit.

Investigator Experience

The University of Louisville is privileged to have many renowned researchers. Please see our InNet database for more information.

Staff Expertise

The central clinical trials office, CTU, was established in July 2008 to offer investigators high-quality research administrative support. The CTU has more than 40 administrative and clinical staff who support research for many of the university’s departments.  Visit http://louisville.edu/research/ctu/about/administrative-staff and http://louisville.edu/research/ctu/about/clinical-staff for more information.

Patient Demographics

The University of Louisville serves a unique patient population. Kentucky sits in the midst of Coronary Valley and the Stroke Belt, so named due to the high prevalence of heart disease, obesity, diabetes, stroke and lung cancer. Unfortunately, Kentucky is also a leader in low educational achievement and high levels of smoking and alcohol use. These factors combine to make Kentuckians especially unhealthy. Its African-American, Hispanic, Appalachian and indigent populations are large, and they are disproportionately afflicted with above noted chronic diseases.

Therefore, the ULRF is well situated to perform clinical and translational research with multiple diverse/minority populations, including children, and to positively impact the health and well-being of these subjects.

Kentucky is second in the U.S. in the incidence of obesity in high school children, ninth in preschool children, tied for second in overweight adults and obese adults, ninth in hypertension, seventh in diabetes, second in physical inactivity and sixth in the highest poverty rates. Segments of Louisville Metro have the highest rates of many of these diseases in the state.

Kentucky ranks fourth among states in cancer mortality. In 2006, nearly 24,000 Kentuckians were diagnosed with cancer and more than 9,300 died of cancer. Kentucky’s overall cancer death rate is 17 percent higher than the national average, and the lung cancer death rate is 45 percent higher than the national average.

Other Information

Since its inception, CTU has focused on improving compliance for research as well as decreasing start-up times for industry-sponsored trials. Over the years, CTU has identified process changes that allow for parallel processes for IRB, contract and budget approvals.

For Patients:
Please check the listing of current trials to determine if a trial is right for you. Also, know your rights as a participant and get information about participation in a clinical trial by visiting the following address: http://louisville.edu/research/humansubjects/participants.

For Sponsors:
CTU is the central clinical trials office at the University of Louisville. CTU is the best point of contact for industry sponsors. The office provides information and communication about clinical research at the university.

CTU is your contact to:

• Identify principal investigators with particular research expertise and interests (investigator identification service);
• Obtain general information about clinical research resources, research capabilities and sponsored research administration; and
• Streamline communications among sponsors, research administrators, PI and research personnel.

CTU is a full-service research support office that provides the following services:

• Protocol placement and feasibility
• Regulatory approval
• Budget development and negotiation
• Billing plan development
• Contract routing
• Clinical coordination
• Grant and manuscript writing

For more information, click here: http://louisville.edu/research/ctu/.