Research Environment and Resources
 

Besides the resources and environment, as detailed in the History of Clinical Research section, there are other existing resources available to the CRCA Program, which represent additional significant intellectual resources for training in clinical research. These include:

Hospitals:

Medical Center Louisiana at New Orleans. The Medical Center of New Orleans originally was founded as Charity Hospital in 1735 and now includes both Charity and University Hospitals. Charity Hospital has been in continuous operation for over 250 years, making it one of the oldest hospitals in the United States. It has played a major role in the development of New Orleans as a regional medical center and has served the educational needs of the Tulane University School of Medicine since its beginning. In addition, it serves as a major site for research and houses the NIH- funded General Clinical Research Center and Clinical Research Organization of New Orleans. The present physical plant includes the older Charity Hospital as well as a newer facility, University Hospital, that is located several blocks westward. The current Charity Hospital first opened in 1939 and now has 700 licensed beds. There were 356,692 outpatient visits, 33,400 inpatient days and 177,841 emergency room admissions last year. There is also a 20-bed detoxification unit and an AIDS treatment and evaluation center. The Tulane medical service consists of 4 general medical services as well as subspecialty units for infectious diseases, hemodialysis, leukemia and coronary and medical intensive care facilities.

Veterans Affairs Medical Center. The Veterans Affairs Medical Center is a 530 bed general medical and surgical hospital located directly across the street from both the Tulane University School of Medicine and Charity Hospital. Two hundred sixty beds are reserved for Tulane medicine and medical subspecialty patients. There were 283,379 outpatient visits and 4,295 inpatients days at the VA Medical Center last year. Specialized facilities in the hospital include a coronary care unit, a medical intensive care unit, sleep laboratory, a chronic hemodialysis unit and a cardiac catheterization laboratory. The VA Medical Center is the site of a well organized department of research with a full?time research director. A large endocrinology research laboratory and general medical, hematology, radioisotope and cardiopulmonary research laboratories are components of the extensive investigation activities that take place there. A new Transitional Care Unit was recently opened which serves as a major component of a new Geriatric Center which includes all three health center hospitals and the TSPHTM.

Tulane University Hospital and Clinic. Tulane University Hospital & Clinic is one of New Orleans' most comprehensive health-care facilities. The 300-bed hospital serves the private patients of the Tulane University Medical Group and offers the latest in diagnostic and treatment facilities. The university hospital provides inpatient and outpatient hospital services and is a site for numerous postgraduate medical education programs and specialized applied research projects. The hospital and clinic are also actively engaged in community education, health promotion and managed-care delivery systems. The medical services offered by Tulane's hospitals and clinics are extensive, encompassing a wide range of specialty departments working to provide the highest level of health-care available in Louisiana.

 

 

Other Resources:

Xavier University of Louisiana. Xavier University is the only university in the United States that is both Black and Catholic. The University dates back to 1915 when Mother Catherine Drexel from the Sisters of Blessed Sacrament founded the co-educational secondary school from which it evolved. In 1927, a College of Pharmacy was opened. Xavier is a predominantly minority institution that historically has placed a greater percentage of its graduates in professional schools of law and medicine than any other university of its kind. According to the U.S. Dept. of Education, Xavier continues to rank first nationally in the number of African American students earning undergraduate degrees in biology, physics and physical sciences. Xavier College of Pharmacy is number one in the nation in Pharmacy degrees all awarded to African Americans. Since 1927, the College of Pharmacy is graduating nearly 25% of the 6,500 Black pharmacists practicing in the United States. In 1994, the College expanded its curriculum to confer only the Dr. of Pharmacy as its professional degree. Additionally, in premedical education, Xavier is the first in the Nation in placing African American students in medical schools. The Interim Dean of the College of Pharmacy, Dr. Robert Thomas, is a member of the CRCA Internal Review Committee and a consultant to the CRCA Program.

NIH Tulane-LSU General Clinical Research Center (GCRC). The GCRC was begun in 1990 under the auspices of funding from the NIH General Clinical Research Centers Program. It is housed at Charity Hospital, contiguous with Tulane Medical School on the east side and LSU Medical Center on the west side. The Program Director, Dr. Juan Lertora, is also Director of the NIH AIDS Clinical Trial Unit and a CRCA Core Faculty member. The Center involves full interdisciplinary cooperation between the three local major medical institutions: Tulane University Medical Center, Louisiana State University Medical Center and Charity Hospital whose facility is shared for teaching and service purposes with both Medical Schools. The specific aims of the GCRC are to provide resources and environment to allow quality inpatient and outpatient care for adult and pediatric patients who are subjects of research projects within the framework of the overall Tulane-LSU-Charity Hospital Medical Complex, and to provide training in the methodology and design of excellent clinical research projects. The GCRC is structurally composed of 10 beds for inpatient research. Within this bed unit is a special area for a study of subjects with contagious diseases and AIDS consisting of rooms with special filters and infection control equipment and facilities. A large outpatient area is present directly adjacent to the inpatient unit. The outpatient unit contains additional examining rooms with beds and several recliners for certain outpatient research studies such as administration of IV regional perfusion, and chemotherapy which is performed in an adjacent room. Another area within the GCRC is the Core Laboratory. This laboratory is used for the performance of metabolic, radio immunoassay procedures and PCR and other molecular biology procedures. The GCRC Core Laboratory is directed by Dr. Sanda Clejan, who will also be directing the component of the CRCA seminar series, "Introduction to Clinical Pathology". The clinical research program within the GCRC includes protocols from such widely diverse departments as medicine, pediatrics, ophthalmology, biomedical engineering, psychiatry/neurology, surgery, pathology, oncology, infectious diseases, nursing, pharmacology, public health and others. The entire facility is used strictly for clinical research projects approved by the GCRC Advisory Committee and staffed by M.D. and Ph.D. faculty of both medical schools, as well as selected medical house-staff or residents, rotating medical students, and graduate students and fellows. There were 722 inpatient days and 5968 outpatient visits in the GCRC last year representing 92 faculty clinical investigators with 117 active protocols.

Dr. Friedman (PI of the CRCA) is the Associate Program Director (Tulane) for the GCRC and his primary responsibility is coordinating the educational and training functions of the GCRC. During the recent successful competitive renewal for the GCRC grant, the training component was ranked as "Excellent."

Clinical Research Organization of New Orleans (CRONOS). CRONOS is a newly established autonomous clinical trials unit, designed to carry out studies necessary for FDA approvals. CRONOS, in large part, evolved from the NIH-funded Tulane-LSU GCRC and is a combined effort of the clinical faculties at LSU Health Sciences Center, Tulane University Medical Center, and Xavier College of Pharmacy. CRONOS is situated in space immediately adjacent to the GCRC on the fifth floor of the Charity Hospital. Inpatient beds and facilities for outpatient studies are available.

Tulane Center for Infectious Diseases (CID). Based on its international reputation in Infectious Diseases including research in tropical medicine and infectious diseases, its strengths in AIDS, malaria, tuberculosis and vaccine research, clinical excellence, and unique patient population, Tulane University established the CID in 1998. The goal of the CID, directed by Dr. Donald Krogstad (CRCA Internal Advisory Committee member), is to enhance research on infectious disease issues of interest to the entire Tulane University Medical Center. The area of greatest relevance to the CRCA Program is the translational clinical research component of the CID which presently interacts with the GCRC and the Primate Center. One current example of this process is the development of aminoquinolines for treatment of otherwise drug-resistant malaria based on compounds which were initially synthesized and characterized at Tulane University, first tested in vivo at the Primate Center and now entering Phase I studies in humans at the GCRC. In basic research, priority areas include the host response to HIV infection, and emerging viruses, with the construction of a Level 4 research space at the Primate Center. In clinical investigation, priority areas include the treatment of HIV infection, nosocomial infection and travel medicine. In public health, the priority areas are immunization in the inner city, and the impact of maternal infection on the fetus. The CID is located in the J. Bennett Johnston Building encompassing the entire 5th floor and was established with a $2.1 million endowment. Total research funding is $1.8 million.

The AIDS Clinical Trials Units. A large AIDS unit is housed mainly in Charity Hospital's facilities. It contains clinical evaluation teams, a pharmacology team, an immunology team, several virology teams and key diagnostic laboratory personnel. The unit is concerned with the study and assessment of the safety and toxicity of candidate drugs and immune response modifiers like interleukin-2 for the treatment of HIV infection in AIDS patients. Since 1996, 362 patients have been enrolled in the clinical trials. Approximately 35% were female, 35% African?American and 11% Hispanic. Of the 128 females enrolled to date, 69% were African?American and about 8% were Hispanic.

Tulane Cancer Center (TCC). The TCC was established in 1993 with a $9 million investment in facilities and program support by Tulane University. The TCC Director is Dr. Roy Weiner (Associate Program Director/Co-Investigator of the CRCA). The TCC offers a complete range of services including prevention and early detection, treatment, rehabilitation, and continuing care. The clinical facility provides space for radiation oncology, an outpatient infusion center, outpatient bone marrow transplant, multidisciplinary outpatient clinics, and psychosocial support services. TCC has already had several notable successes: It has pioneered a new treatment for localized prostate cancer that reduces pain and shorten hospitalization (Dr. Andrew Schally our Nobel laureate and Dr. Anna Maria Schally a GCRC investigator); it has also pioneered novel therapeutic efforts using bone marrow transplantation; and it provides clinical trials, sponsored by the National Institutes of Health (i.e., SWOG, RTOG, NSAP, GOG, POG) and investigator initiated clinical research using the GCRC. The TCC has an Office of Clinical Research which coordinates and manages all cancer clinical trials at Tulane. The TCC also has clinical research agreements with 11 community practices along the Gulf Coast. More than 180 patients were accrued to clinical trials in 2000. The research of the TCC are organized into three programs (Signal Transduction in Cancer, Cancer Genetics and Gene Therapy, and Environmental and Viral Carcinogenesis). In addition, the TCC provides training for 6 clinical fellows in Medical Hematology/Oncology and 2 clinical fellows in Pediatric Hematology/Oncology and 2 surgical oncology trainees via a NIH-sponsored T-32 Surgical Oncology Training Grant (The PI is Dr. Bernard Jaffe, a CRCA Internal Advisory Committee member). There are 29 funded basic and clinical science investigators in the TCC with a total of $3.8 million in NIH research grants.

The NIH-Funded Specialized Center of Research in Atherosclerosis. This large Center, located within the Tulane School of Public Health, has been operational for many years and has made major advances in our understanding of the natural history and progression of atherosclerosis from childhood to old age. A main component of this Center is the widely recognized "Bogalusa Project" of Dr. Gerald Berenson in which citizens of this small Louisiana town have been followed from early childhood through their adult years for monitoring of lipid profiles and risk factors associated with development of atherosclerosis and coronary disease. This longstanding Bogalusa Heart Study Program is funded by the NIH at $870,000/year.

TSPHTM Hypertension Program. With the recruitment of Dr. Paul Whelton to Tulane, where he now serves as the Senior Vice-President for the Health Sciences, an internationally recognized program in hypertension is now in place and active at Tulane. The studies include the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), which is a randomized, double-blind, active-controlled trial of 42,448 participants that is sponsored by the NHLBI. Dr. Paul Whelton is Principal Investigator for one of the nine ALLHAT Regional Coordination Offices (Mid-Atlantic States Region), providing clinical center monitoring/oversite for 64 of the 625 ALLHAT Clinical Sites. ALLHAT is designed to determine whether the incidence of the primary outcome - a composite of fatal coronary heart disease (CHD) and nonfatal myocardial infarction (MI) - differs between treatment with a diuretic and treatment with each of three other types of antihypertensive drugs in high-risk hypertensive persons aged 55 years and older. Other ongoing projects include studies investigating lifestyle factors, including dietary nutrients (high sodium, low potassium, low vegetable protein, and low water-soluble fiber), overweight, physical inactivity, and alcohol consumption as risk factors for hypertension in over 20,000 study participants living in Southwestern China. The total research support for this program is $3.8 million.

In addition to these programs, significant research is being done on the basic level in the Departments of Medicine and Physiology in hypertension. Together these 2 Departments have more than a dozen current national grants (NIH, VA, and NASA). These are currently being integrated into a multidisciplinary Clinical and Research Hypertension Center, led by Dr. Hamm, a CRCA Internal Advisory Committee member.

The Tulane Peptide Cancer Research Center. This research center was dedicated in honor of Dr. Andrew Schally, our Nobel Laureate at Tulane University Medical Center. Dr. Schally heads this Center which is housed at the VA Hospital. The well equipped laboratories of the Center have always been primarily concerned with the preparation and development of LHRH and somatostatin analogs in the treatment of endocrine-dependent breast, ovarian, prostate, pancreatic and other related tumors. Dr. Schally participates with investigators throughout the world in conducting clinical trials of many of his synthetic peptides which are also used in patients with several of the above mentioned diseases at the GCRC.

The Lindy Boggs Biotechnical and Energy Center. This Center is located on the main Tulane University campus. The Center contains projects that are relevant to the CRCA clinical research program. These include, e.g., comparison of recording of lung breath sounds to physiologic data obtained by pulmonary function testing and design and placement of percutaneous electrodes in electroencephalography. The Center also carries out many other predominantly biomedical projects including many related to engineering innovations for the handicapped and the biomechanics of several bony joint surfaces. The interchange between the BME faculty of the Boggs Center and our CRCA will result in the application of many of these innovative engineering model studies to the CRCA Clinical Research Program.

Tulane Xavier National Center of Excellence in Women's Health. The Tulane Xavier National Center of Excellence in Women's Health (TUXCOE) is one of the 17 nationally designated Women's Centers by the Office on Women's Health (DHHS). TUXCOE is a collaborative effort of Tulane University Medical Center, Tulane University Hospital, and Xavier, Loyola, and Dillard Universities. It is directed by Jeannette Magnus, M.D., Ph.D. who is also a member of the CRCA Internal Advisory Committee. The Center incorporates the clinical, academic, and educational missions of these institutions into a community network. The 5 major components of the Center as designated by DHHS are:1) clinical services that are provided as a deliver model using a "center without walls" approach onsite and in satellite locations; 2) a multidisciplinary research agenda to achieve a fuller understanding of women's health issues; 3) health professional education, including training as part of an integrated women's health curriculum in medical education; 4) community outreach to provide consumer education and information on women's health within the surrounding communities; and 5) a leadership plan of strategies to foster the recruitment, retention, and promotion of women in academic medicine.

Tulane Center for Clinical Effectiveness and Prevention. This is a new program that is a joint collaboration for the Tulane School of Medicine and the TSPHTM. It is directed by Dr. William C. Steinmann, a member of the CRCA core faculty. The Program is targeted primarily to individuals who are interested in clinical investigative careers in clinical epidemiology. The program is open both to students in the School of Public Health as well as those obtaining joint MD/MPH degrees.

The Hayward Human Genetics Center. This Center, located on the fifth floor of the main Tulane Medical School building is headed by Jess Thoene, M.D. It is primarily concerned with genetic diseases and counseling of patients, particularly children with many forms of inherited diseases referred to the Center by maternal and child health programs, handicapped children services, and family planning programs locally and elsewhere. A prominent long-standing NIH contract study carried out at the Center is concerned with the effects of maternal phenylketonuria (PKU) on pregnancy outcome. The Center provides counseling and clinical evaluation for referred patients, chromosome studies of patients, amniotic fluid analyses from prenatal patients, biochemical testing for a variety of genetic disorders, and follow-up educational services. Dr. Thoene is a member of the CRCA Internal Advisory Committee.

Tulane Gene Therapy Program. The Tulane Center for Gene Therapy is under the directorship of Darwin J. Prockop, MD, PhD. Dr. Prockop has a distinguished career and his pioneering research is recognized throughout the world. He has been honored by his peers in many ways, including election to the National Academy of Science, two honorary degrees, and the Lee C. Howley Prize from the Arthritis Foundation for research on arthritis. The Center develops new therapies for a series of common diseases that include osteoporosis, osteoarthritis, parkinsonism, spinal cord injury, stroke and Alzheimer's disease. The primary strategy of the Center is to use adult stem cells that can easily be obtained from a patient and then used for therapy in the same patient. The Center will also provide educational programs for career development, job training and life long learning of citizens; establish a forum to evaluate the social, legal and ethical implications of gene therapy; and develop commercial applications of gene therapy with an emphasis on commercial developments within the State of Louisiana. The Center is supported by research funds from the federal government via National Institutes of Health grants, from the state of Louisiana via the Louisiana Gene Therapy Research Consortium and the Louisiana Board of Regents, from the Tulane University Health Sciences Center, the HCA - Healthcare Company and several private foundations. The Center is a major participant in the Louisiana Gene Therapy Research Consortium that includes gene therapy centers at the LSU Health Sciences Centers in New Orleans and in Shreveport. The Center was launched with a staff of 15 who moved with Dr. Prockop from Philadelphia. It now has a staff of over 30 with plans to increase the staff to about 50 within the next year or two. The Center is housed in 14,000 sq. ft. of modern laboratory space in the Tulane University Health Sciences Center's J. Bennett Johnston Building.

The Cystic Fibrosis Center. This long-standing clinical Center at Tulane University Medical School is designated as a core teaching and clinical research center by the Cystic Fibrosis Foundation which funds this Center. It has a base of over 500 patients. Investigator for both pediatric and adult cystic fibrosis patients, Dr. Friedman, is also the Associate Director of the Adult Cystic Fibrosis Program.

The Comprehensive Hemophilia Care Center (CHCC). This Center is headed by Dr. Cindy Leissinger, a TCC investigator, and located at Tulane University Medical Center Hospital. The Center concentrates on treatment of hemophilia and has closely interacted with the Pediatric AIDS Center. The CHCC investigators, working partly out of the GCRC, were among the first in the country to perform in depth studies of AIDS in hemophiliac patients.

Ernest N. Morial Asthma, Allergy and Respiratory Disease Center. This Center is part of LSU Medical Center, adjacent to Charity Hospital, and is one of only four state designated Centers. The faculty of the Center have in excess of one million dollars in NIH direct grant funding annually. Participants in the Center have also been active in 59 NIH and pharmaceutically sponsored multicenter clinical trials. It is the central focus of this facility to conduct innovative research combining the talents of both basic and clinical scientists in order to develop cutting edge treatments or discover the means to prevent or cure asthma. Dr. Dwayne Thomas, is the Center's Director and directs with Dr. Friedman (PI of the CRCA) an asthma management program at Charity Hospital.

The Center for Applied Environmental Public Health. The Center for Applied Environmental Public Health (CAEPH) leads the distance education programs at the TSPHTM. CAEPH has pioneered work in the integration of computing and communication technologies as delivery tools and in the development and evaluation of teaching methods and materials to optimize learning in distance education. CAEPH is one of the first to fully integrate computing capabilities and communication technology.

The U.S.-Japan Biomedical Research Center and Laboratories for Molecular Neuroendocrinology and Diabetes (LMNED). This is a large research center on 500 acres of ground located about a 10 minute ride from the Tulane University Medical Center and is directed by Akira Arimura, M.D., Ph.D. The Center is funded jointly by NIH grants and private Japanese sources. It focuses on isolation, synthesis and characterization of neuroendocrine peptides that interact with the hypothalamic pituitary axis. A major NIH funded project within this center is a clinical trial of P.A.C.E.P. (Adenyl cyclase acting peptide) in patients with acute cerebral vascular accidents. Other prominent projects at the center relate to the effects of certain cytokines on hormone release by the hypothalamic pituitary axis and studies of other PACEP-like peptides that appear to be essential for nerve growth and studies related to the isolation, characterization and biologic activity of gonadal polypeptide.

Centralized Tulane Imaging Center (CTIC). This Center offers Computerized Imaging and flow cytometry analysis to Tulane staff for a nominal fee and is located on the 6th floor of Tulane Medical School. The CTIC houses: a) a two laser ELITE Coulter Cytometer; b) an IX70 Olympus top-of-the-line inverted microscope; c) a BH2 upright microscope with phase contrast, Normanski, fluorescent and bright modes; d) 1100x1300 pixel digital SPOT camera attached to a Pentium computer with PhotoShop and Image-Pro imaging software; and e) VoxBlast 3-D reconstruction and Microtome II digital deconvolution (digital confocal) plus peripheral components for publication quality output. There is also analog color imaging and pixel analysis. Dr. Cesar Fermin is the Director.

South Central Public Health Leadership Institute. The South Central Public Health Leadership Institute (SCPHLI), implemented in the fall of 1995, is the first regional collaboration offering leadership development and enhancement for practicing public health professionals. It is a joint effort between TSPHTM and the state offices of public health of Alabama, Arkansas, Louisiana and Mississippi, and Texas. SCPHLI is a year?long program with three on?site sessions per year. The Institute is directed to experienced public health professionals who are currently in positions of leadership with supervisory, programmatic, and/or fiscal responsibilities within public health programs. The Institute is supported in part by a grant from the Centers for Disease Control and Prevention.