The Clinical Research Organization at the University of Medicine and Dentistry of New Jersey (UMDNJ) assembles the expertise, resources, intellect and motivation of faculty and staff across three medical schools and a dental school, six clinical research centers, and the technical and scientific capabilities of a state-wide institution to conduct clinical research in nearly all therapeutic areas. Each school and campus provides their own set of comprehensive research activities and is supported by a core of shared administrative competencies in human subjects protections, financial management, legal management and technology transfer. The CRO provides a portal into the University to select services at specific sites, or concurrent services at multiple sites across the state; it matches internal capabilities with external constituents. A full description of our main biomedical research schools can be found at the following CenterWatch.com links:
- New Jersey Dental School, Newark
- New Jersey Medical School, Newark
- Robert Wood Johnson Medical School, New Brunswick
- Cancer Institute of New Jersey, New Brunswick
- School of Osteopathic Medicine, Stratford
The UMDNJ CRO may be reached by contacting Ms. Debbie McCloskey, RN, BSN at CRO@umdnj.edu.
New Jersey Medical School (NJMS), located in Newark, NJ, is one of three medical schools at the University of Medicine and Dentistry of New Jersey (UMDNJ). NJMS has four mission areas: education, research, clinical care and community outreach. The school has 21 departments, more than 70 centers and institutes, and eight areas of excellence to highlight advances in disciplines to which considerable resources have been dedicated. These areas of excellence are: Brain Injury and Stroke, Cancer/Oncology, Cardiovascular Biology, Cellular Signal Transduction, Immunology, Infectious Diseases, Neurosciences and Psychiatry/Behavioral Sciences. NJMS conducts basic, translational and clinical research, receives significant research grants and awards, and holds an impressive list of groundbreaking discoveries by a world-class cadre of researchers.
The schools major centers and institutes include:
- NJMS/UH Cancer Center/New Jersey Cancer Center (NJCC)-- Although opened only in October 2006, this nine story, 220,000 square-foot, dedicated facility is already the focus of multiple campus-wide activities in research, education, and health care. The facility is home to the Center's initial phase of 100 faculty, staff and graduate students. Faculty are drawn from 10 academic departments, a mixture of basic science and clinical departments facilitating a diverse perspective to innovative cancer research. The NJCC also offers the successful Cancer Clinical Trials Program for access to advanced care for underserved populations. In 2008, physicians at the Center treated some 1,100 new patients for a variety of cancers; more than 60 percent were minorities. NJCC was recently designated by the National Cancer Institute as a Minority Based Community Clinical Oncology Program (MBCCOP) to enable people in the local community to participate in cancer prevention, cancer control, and cancer treatment research through local physicians and community hospitals.
- Global Tuberculosis Institute - Under the direction of Lee B. Reichman, MD, MPH, the Institute achieved federal designation as a national Model Tuberculosis Prevention and Control Center in 1994, indicating its success in delivering state-of-the-art treatment, providing education and training and conducting cutting-edge research. The Institute has been conducting trials as early as 1970 and provides outpatient services at a new state-of-the-art clinical facility.
- The Public Health Research Institute (PHRI) - Founded as an independent, not-for-profit research organization in 1941 in New York City, PHRI moved to Newark in 2002 to join the International Center for Public Health, an infectious disease research consortium comprised of The Global TB Institute, the Department of Microbiology and Molecular Genetics, and the School of Public Health. PHRI investigators lead in areas such as tuberculosis, HIV, fungal infections, drug resistance and diagnostics.
Major health care partners include University Hospital, University Behavioral HealthCare, Veterans Affairs New Jersey Healthcare System, and Hackensack University Medical Center. The school also has established clinics in local communities.
University of Medicine and Dentistry
UMDNJ, founded in 1970, has eight schools located throughout New Jersey. Our main campuses are Newark, Piscataway/New Brunswick, Stratford and Camden. Our campus collectively inhabits 185 acres, 64 buildings, 7.2 million square feet.
Our Schools include:
- New Jersey Medical School
- Robert Wood Johnson Medical School
- School of Osteopathic Medicine
- New Jersey Dental School
- Graduate School of Biomedical Sciences
- School of Health Related Professions
- School of Nursing
- School of Public Health
UMDNJ Clinical Research Organization:
- The University Clinical Research Organization (CRO) offers a gateway for current and future patients and sponsors into campus-wide clinical trial activities.
- The University CRO works with private sponsors to provide a single University-wide contact.
- The University CRO works with clinical trial units and research offices of each UMDNJ school to efficiently and effectively match trial and sponsor needs with University resources.
Our health care system includes:
- 2.3 million patient visits to UMDNJ healthcare facilities and faculty practice offices last year.
- Owns and operates UMDNJ-University Hospital (UH) in Newark with 22,192 admissions.
- 221,371 outpatient visits last year
- Owns and operates University Behavioral HealthCare (UBHC), a state-wide behavioral health care provider.
- 4 Principal Teaching hospitals (affiliated)
- 3 University hospitals (affiliated)
- Affiliations with more than 80 New Jersey hospitals and/or health systems
- More than 15 statewide centers of excellence
- UMDNJ's clinical practices have off campus offices in 32 New Jersey communities.
- UMDNJ has healthcare affiliates in each of New Jersey's 21 counties.
NJMS has basic, translational and clinical research in all its areas of excellence, as well as in its expanding departments. Disciplines with greater concentrations of clinical research expertise include cancer, cardiology and vascular diseases, infectious disease, rehabilitation and ophthalmology. Clinical research experience is not limited to these areas and can be found in nearly all departments, including psychiatry and behavioral sciences, alternative medicine, anesthesiology, gastroenterology, and neurology. Below are descriptions of some larger areas of research experience.
Cancer
Over 75 researchers from the New Jersey Medical School, including physicians and scientists, collaborate with the CCNJ to form the Cancer Center Community (CCC) at NJMS on the UMDNJ Newark Campus. This approach leverages the collective wisdom and expertise into more effective and efficient care for the patient. The clinical mission brings together surgical, medical and radiation oncologists with supporting disciplines such as breast, gastrointestinal, genitourinary, gynecologic hepatobiliary, lymphoma/leukemia, neurological pediatric, pulmonary, alternative medicine, and palliative care. CCNJ has formed collaborative agreements with nine National Cancer Institute (NCI)-approved cooperative groups. NJMS faculty serve as on-site principal investigator liaisons for each group, and nine disease-specific tumor boards meet regularly to discuss patient care. Currently, they have numerous active protocols and are in a rapid growth phase, opening dozens of additional NCI-approved clinical trials.
Infectious Disease
The Global Tuberculosis Institute is at the forefront of finding more effective ways to prevent and treat tuberculosis through research. Currently, the Institute is participating in the study of new drug regimens that could shorten tuberculosis treatment. It is a member of the Centers for Disease Control and Prevention Tuberculosis Trials Consortium and Tuberculosis Epidemiologic Studies Consortium. The Institute also collaborates closely with several of UMDNJ's centers and departments, including the Center for Emerging Pathogens and the Public Health Research Institute. These relationships create a unique synergy in which TB elimination can become a reality.
The Infectious Disease Practice continues to grow at NJMS. While the department boasts of a broad scope of research interests, the HIV/AIDS clinical research program has accelerated over the past few years. This practice has recently successfully brought the Adult AIDS Clinical Trials Group, as well as a new NIH Division of AIDS (DAIDS) Prevention Trial Network Site to NJMS.
Ophthalmology
The Center for Macular Degeneration Treatment and Research provides state-of-the-art treatment for Age-Related Macular Degeneration (AMD), including the latest FDA approved treatment modalities for neovascular AMD - Macugen (pegaptanib sodium injection) and photodynamic (Visudyne) therapy. The Center is involved in a number of research projects and clinical trials including those related to various aspects of photoreceptor and retinal pigment epithelium transplantation. The Institute of Ophthalmology and Visual Science conducts clinical research in cornea surgery, topography, imaging and other ophthalmologic analysis and interventions.
Neurology
The department of Neurology and Neuroscience offers excellence in clinical research in Multiple Sclerosis and neuroimmunology, endovascular treatment of acute stroke, autism, and epilepsy including epilepsy surgery. Research achievements by department faculty include conducting broad-based, instrumental trials in testing critical drug therapies for Multiple Sclerosis and honing efficient and effective protocols for stroke patients. The department values collaboration between physicians, physician-scientists and scientists to accelerate expertise in research and patient care.
The school has significant experience in nearly all levels of clinical research in a broad breadth of therapeutic areas. As investigators and scientists, our faculty are internationally known as prominent leaders in their respective fields. As physicians, they are motivated to improve not only the general health status of our state, country and world at large, but are also dedicated to applying the best medical care to each patient.
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The research staff has extensive experience in initiating and conducting clinical research projects of all phases and magnitudes. Their expertise includes, but is not limited to, study coordination, data and project management, human rights protection, patient safety and Good Clinical Practices, regulatory compliance, contracts and budgets, and coordinator support for new investigators. Our staff is well versed in acting as a central contact for sponsors and CROs.
We serve an economically and ethnically diverse patient population from the entire state of New Jersey and parts of Pennsylvania.
Cardiology/Vascular Diseases
Dermatology/Plastic Surgery
Endocrinology
Gastroenterology
Hematology
Musculoskeletal
Nephrology/Urology
Neurology
Obstetrics/Gynecology
Oncology
Pediatrics/Neonatology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology
Trauma/Emergency Medicine
In addition to employing state-of-the-art treatment tools and innovations, clinical care at NJMS is provided in a variety of in- and out-patient settings. These facilities offer clinical trial patients unparalleled care in convenient and welcoming environments. At the same time, a focus on specialty areas of medicine - including infectious diseases, cardiovascular science, neurological and visual sciences, cancer and trauma - ensures that NJMS meets a wide range of patient needs. The principal teaching hospital and inpatient care provider of NJMS is University Hospital, located next to NJMS on the Newark campus, and is the tertiary referral center for many of the state's most advanced medical services and specialty care programs. UMDNJ Newark campus opened the new the Ambulatory Care Center in January 2006. The six-story, 185,722 square facility includes services for pediatrics, infectious diseases, surgery, medicine, and urology. The surgery department accommodates subspecialties such as podiatry, infusion, and ENT with audiology. The Department of Medicine houses several components including gastrointestinal, hypertension, dermatology, cardiology, nephrology, metabolic and endocrine. Patients of clinical trials may also be seen at other major UMDNJ-affiliated institutions, including the Veterans Affairs New Jersey Healthcare System and Hackensack University Medical Center. The largest clinical research centers are the University Hospital and Clinical Research Unit, the NJMS Cancer Center Clinical Research Office, and the clinical research center at the Global Tuberculosis Institute. These school research offices coordinate with the University Clinical Research Organization, which is the prime contact for privately sponsored trials.
New Jersey Medical School/University Hospital Center for Clinical and Translational Research
The Center for Clinical and Translational Science (CTS) operates jointly with NJMS and UH. The center offers comprehensive guidance, services and resources for clinical investigators and their support staff to streamline the conduct of clinical research from inception to maintenance, including but not limited to
- protocol development,
- study initiation and conduct,
- clinical research budget and billing, and
- regulatory support.
The CST houses New Jersey Medical School/UH Clinical Research Unit (CRU) and the NJMS-UH Cancer Clinical Research Office (CCRO) and . The CRU, located within University Hospital provides dedicated space, resources and services to conduct inpatient and outpatient clinical research in all medical disciplines. The CRU provides an optimal setting for medical investigators to conduct safe, controlled, state-of-the-art, inpatient and outpatient studies of both children and adults. It offers the comprehensive services of research patient care, study coordination, sample processing and research consultation for both investigator-initiated research and industry-initiated research.
The CCRO, located in the NJMS New Jersey Cancer Center, provides state-of-the-art clinical trials to the patient community served by the cancer center. The NJCC is physically connected to UH, allowing patients to access additional clinical services, clinical research opportunities, screening and education programs and administrative offices. Recently awarded NCI designation as a minority based Community Clinical Oncology Program, the CCRO will look to integrate care with community providers. The center has an innovative extramurally funded patient navigator program to identify patients eligible for protocols, enlist them for participation in clinical trials, and help keep them on track through completion of their treatment and any necessary follow up.
Global Tuberculosis Institute - Waymon C. Lattimore Practice
The practice was established more than three decades ago and is part of the Ambulatory Care Services at UH. It is designated by the New Jersey Department of Health and Senior Services as a Regional TB Clinic, serving Essex and Union County. Clients are assigned to a multi-disciplinary healthcare team based on their geographic location. Pulmonary and infectious disease specialists provide adult and pediatric medical care. Directly Observed Therapy (DOT) will be arranged with the client at their initial intake encounter. Clients may receive their medications at the clinic, at their home, workplace, or other designated site. Patient-centered care is provided through a multi-disciplinary team approach to address the complex clinical, social and cultural issues that impact the prevention, control and elimination of tuberculosis.
New Jersey Medical School Research Cores and Facilities
Core facilities provide access to the latest technologies including flow cytometry, proteomics and genomics, and imaging. Substantial growth in the core facilities has occurred in the last several years. Recent awards of several NIH Shared Instrumentation Grants have allowed facilities to continue to expand and meet the needs of the faculty. New cores include the Biostatistics core, the Office of Clinical Research, and the Flow Cytometry Core.
- Biostatistics Core
- Center for Advanced Proteomics Research (CAPR)
- Center for Genome Informatics
- Comparative Medicine Resources (CMR)
- Experimental Histology & Advanced Microscopic Imaging Core
- Histology Core - Confocal Imaging Facility (CIF)
- Flow Cytometry Core Laboratory
- Molecular Resource Facility (MRF)
- Transgenic Core Services
- Other Research Cores and Facilities
- Center for Applied Genomics (CAG)
- NJDS-Electron Microscopy Facility
- Institute of Genomic Medicine (IGM)
- Irradiation Facility
- IVIS Imaging Systems
- Regional Biocontainment Lab (RBL)
- X-Ray Crystallography Facility
The NJCC is the new home to six NJMS Core Research Facilities. The Digital Imaging Core houses 2 confocal microscopes, a PALM laser capture scope, tissue processing services and a host of support resources. The Center for Advanced Proteomics Research offers a variety of equipment and services for the design, process, acquisition and analysis of proteomics-based research. The NJCC also contains satellite facilities of the Flow Cytometry and Comparative Medicine Cores, and is home to the Biostastics Core and Clinical Research Group.
Sonia Kleiner
Executive Director
UMDNJ-New Jersey Medical School
Office of Clinical Research
185 So. Orange Avenue, PO Box 1709
Newark, NJ 07101-1709
USA
(973) 972-9691 or NJCC: (732) 418-8484
(973) 972-9670 or NJCC: (732) 418-8480 (fax)
kleiness@umdnj.edu