University of Louisville Research Foundation (ULRF)

Center Information

Clinical Trials Unit (CTU)
University of Louisville Research Foundation (ULRF)
501 E. Broadway, Suite 210
Louisville, KY 40202
USA
502-852-1006
502-852-2610 (fax)
ctu@louisville.edu
louisville.edu/research/ctu
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Currently Enrolling Trials

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Therapeutic Areas

Cardiology/Vascular Diseases
Dental and Oral Health
Dermatology
Endocrinology
Family Medicine
Gastroenterology
Hematology
Hepatology (Liver, Pancreatic, Gall Bladder)
Immunology
Infections and Infectious Diseases
Musculoskeletal
Nephrology
Neurology
Nutrition and Weight Loss
Obstetrics/Gynecology (Women’s Health)
Oncology
Ophthalmology
Orthopedics/Orthopedic Surgery
Pediatrics/Neonatology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology
Sleep
Trauma (Emergency, Injury, Surgery)
Urology
Vaccines

Center Overview

The University of Louisville (UofL) 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. UofL 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 UofL Health Care Outpatient Center. The clinical care of UofL Health Care continues to receive recognition. UofL Hospital is the site of the nation’s first Trauma Center, which 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.UofL faculty provide clinical care at each of these facilities

In the heart of downtown Louisville, the center offers the largest concentration of health care 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.

Performance Metrics

Number of Studies Conducted: 300

Clinical 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

Facility Description

University of Louisville Clinical Trials Unit Outpatient Research Clinic

Center Overview

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 all outpatient research studies.

Facility Description

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

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.

    Outpatient Research Clinic Staff Expertise

    The CTU Outpatient Research Clinic employs 2 nurse practitioners and 5 full time clinical research nurses and coordinators. The professionals in this clinic have an average of ten years of experience in clinical research. These personnel have education/certifications in the following areas: Clinical Research Coordinator, Bachelors of Nursing Masters of Nursing, and Advanced Practice Research Nurse.

    For specific personnel information, please visit our website

    UofL 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 health care 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, that is part of UofL 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 health care locations throughout Kentucky and southern Indiana, including the Frazier Rehabilitation Hospital and the Rudd Heart and Lung Center, and encompassing nearly 1,700 beds and serving 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 United States 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, which 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, Spinal Cord Medicine Program and Locomotor Training Program. Therapy gyms located on each floor and patient rooms offer a full spectrum of 24-hours-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 boasts 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 non-surgical options encompassing cardiac catheterizations, angioplasties, electrophysiology studies, pulmonary function testing and hyperbaric medicine.

    Louisville VA Medical Center is an acute care hospital located approximately 4 miles from the main Medical Center Campus housing the inpatient population and multiple primary and subspecialty care outpatient facilities. Several specialized programs exist at the Louisville VA Hospital including the regional center for bariatric surgery; home based primary care providing personal home monitoring and telehealth management of chronic obstructive pulmonary disease, congestive heart failure, and diabetes; and hospice and palliative care programs.

    Norton Healthcare is a not-for-profit organization, which operates 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, Indiana, Southern Indiana Medical Center, Charlestown, Indiana, and Regional Medical Center in Madisonville, Kentucky.

    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 over 40 administrative and clinical staff that support research for many of the U of L departments.

    http://louisville.edu/research/ctu/about/administrative-staff

    http://louisville.edu/research/ctu/about/clinical-staff

    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.

    Sponsors

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

    Abbott LaboratoriesKAI Research, Inc.
    ACM Medical TechnologiesKendle International, Inc.
    Agennix, Inc.LAAx, Inc.
    Alba Therapeutics CorporationLevitronix LLC
    Altor Bioscience CorporationMead Johnson & Company
    Amgen, Inc.MedImmune, Inc.
    Angstrom Pharmaceutical, Inc.Merck & Co., Inc.
    Aspect Medical Systems, Inc.Micrus Endovascular Corp
    Astellas Pharma US, Inc.Mpex Pharmaceuticals, Inc.
    AstraZeneca LPNCGS Laboratories Inc.
    Bard Peripheral Vascular, IncNewLink Genetics Corporation
    Baxter Healthcare CorporationNMT Medical, Inc.
    Bayer HealthCare PharmaceuticalsNovartis Pharmaceuticals Corp.
    Bayside Health ABNNovartis Vaccines & Diagnostics
    Benechill, Inc.NxStage Medical, Inc.
    BioMarck Pharmaceuticals, LtdPacira Pharmaceuticals, Inc.
    Biosite IncorporatedParexel International Corporation
    BioVex IncPDL BioPharma, Inc.
    Boehringer-IngelheimPenumbra, Inc.
    Bristol Myers SquibbPfizer, Inc.
    Celator Pharmaceuticals, Inc.Pharmacogenetics Diagnostic Lab. (PGx)
    Celgene CorporationPharmaNet LLC
    Centocor Ortho Biotech Services, LLCPPD Development, LLC.
    Cerexa, IncPRA International, Inc.
    Certus International, Inc.Provectus Pharmaceuticals, Inc.
    Chiltern International Inc.Queen's University
    Cleveland Clinic FoundationQuintiles, Inc.
    Clinical Trial Management Services, Inc.Regenerex
    Clinimetrics Research Associates, Inc.Regeneron Pharmaceuticals, Inc.
    CoAxia, Inc.ReSearch Pharmaceutical Services, Inc.
    Concentric Medical, Inc.RH Bouchard & Associates
    Conor MedsystemsRoche Diagnostics Operations, Inc.
    CovanceRoche Laboratories, Inc.
    Duke Clinical Research Inst.Rockwell Medical Technologies, Inc.
    EKR Therapeutics, Inc.Ross Products Div., Abbott Laboratories
    Elan PharmaceuticalsSalix Pharmaceuticals, Inc.
    Eli LillySanofi Pasteur
    EMMES Corporation, EPP (NCI)Sanofi-Aventis U.S.
    Endo Pharmaceuticals Inc.SC Liver Research Consortium
    Endocyte, Inc.Schering-Plough Corporation
    Epigenomics, IncSchwarz Biosciences, Inc. (UCB acquired)
    FibroGen, Inc.SIRTeX Medical Ltd
    Gambro Renal ProductsSouthwest Oncology Group
    Gemin X, Inc.Spiration, Inc.
    Genentech, Inc.SRA International, Inc.
    GenzymeSt. Jude Medical
    GileadSunshine Heart
    GlaxoSmithKlineTakeda Pharmaceuticals North America Inc
    HeartWare, Inc.TKL Research, Inc.
    Hoffmann-La Roche Inc.United BioSource Corporation
    Hollis-Eden Pharmaceuticals, Inc.Vical, Inc.
    Hospira, Inc.ViroPharma, Inc.
    i3 ResearchW. L. Gore and Associates
    ICON Clinical ResearchWeill Medical College
    INC Research, Inc.Welch Allyn Inc.
    Inspire Pharmaceuticals, Inc.Westat
    Johnson & Johnson Pharm.Res.Dev.LLCWyeth Pharmaceuticals, Inc.

    Patient Demographics

    U of L serves a unique patient population. Kentucky sits in the midst of “Coronary Valley” and the “Stroke Belt” with 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, as well as 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, number nine 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% worse than the national average, and the lung cancer death rate is 45% higher than the national average.

    Other Information

    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 information about participation in a clinical trial by visiting the following address:
    http://louisville.edu/research/humansubjects/participants

    For Sponsors
    The Clinical Trials Unit (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 University of Louisville.

    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
    • Streamline communications among sponsor, 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/

    Contact Center

    If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the email form below. A representative from the research center will then follow up with you.