CLINICAL RESEARCH UNITS
Dedicated clinical research units (CRUs) for conduct of clinical studies
The mission of the CCTS CRUs is to facilitate clinical research by providing investigators with specialized facilities, personnel, and advice. Investigators from CCTS institutions (UTHSC-H, M. D. Anderson Cancer Center, and Memorial Hermann Hospital System) can use any of the CCTS CRUs, depending on the location of their patients and the availability of services at the three CRUs. (Investigators without faculty appointments at UTSHC-H or M. D. Anderson should apply for CCTS membership (see Who Can Use the CCTS?). For assistance designing and implementing clinical studies at the UTHSC-H CRU at Memorial Hermann—Texas Medical Center, please also see the SPARK program.
Director: Michael Fallon, MD Michael.B.Fallon@uth.tmc.edu 713-500-6677
Contact Person: Denee Velaquez Denee.Velazquez@uth.tmc.edu 713-500-7928
Nurse Manager: Kathy Franco, RN Kathy.D.Franco@uth.tmc.edu 713-704-4147
UTHSC-H CRU at Memorial Hermann—Texas Medical Center began as the UTHSC-H General Clinical Research Center in 1986. The UTHSC-H CRU at Memorial Hermann—Texas Medical Center offers 6 outpatient and 4 inpatient rooms; skilled nursing assistance; assistance with processing of laboratory samples; scheduling diagnostic tests and procedures; a research dietician; a chart room; and a physician charting area. For more information on the UTHSC-H CRU at Memorial Hermann— Texas Medical Center, see its web site. To use this CRU, investigators must complete the UTHSC-H iRIS/CCTS application.
Click here to access the CRU Budget Template & Memorial Hermann Hospital Ancillary List. Click here to access the Memorial Hermann Hospital Ancillary List only. (Please note that MHH does not publish their ancillary prices, however completing the template will expedite the budget process.) Once you have completed the appropriate template, please save it and/or attach to your iRIS application as a document. If you wish to create a pre-iRIS budget, please forward your saved budget template along with your protocol to Kathy.D.Franco@uth.tmc.edu and Yvette.Range@memorialhermann.org. For ancillaries only, please forward the completed Memorial Hermann Hospital Ancillary List to Yvette.Range@memorialhermann.org.
Director: Joseph McCormick, MD
Medical Director: Rose Zavaletta Gowen, MD
Nursing Clinical Supervisor: Anne Renfro, MSN, RN
Contact Person: Christina Villarreal Christina.Villarreal@uth.tmc.edu 956-882-6677
Since 2004, the Brownsville CRU has been an integral part of the UTHSC-H General Clinical Research Center, which is now part of the CCTS. The unit is affiliated with The University of Texas School of Public Health (SPH) Brownsville Regional Campus and its Hispanic Health Research Center which focuses on diseases that are common in Hispanic populations. Brownsville is part of Texas’ Lower Rio Grande Valley, which is more than 86% Hispanic and has a high incidence of chronic degenerative diseases, including diabetes, hypertension, and coronary disease. The area also has severe health disparities and a high proportion of uninsured and indigent inhabitants. Through their programs, the SPH Brownsville Regional Campus, the Hispanic Health Research Center, and the Brownsville CRU hope to improve the health of the local community.
To conduct clinical research in the Lower Rio Grande Valley, the Brownsville CRU uses a unique team approach tailored to the local community. CRU investigators support the use of promotoras, who are Spanish-speaking community health workers who assist in subject recruitment and are trained in human subject protection and the intricacies of the studies on which they are working. The promotoras work in various settings in the community to identify potential subjects for clinical studies.
The Brownsville CCTS CRU is situated in Brownsville, TX, less than a mile from the U.S./Mexico border. It is located at the Valley Baptist Brownsville Medical Center, close to the UT School of Public Health Regional Campus (RAHC) (shown above), which is located on the host campus of UT-Brownsville. The local population is about 95% Mexican American.
The Brownsville CRU is in the Professional Building of the Valley Baptist Hospital-Brownsville, adjacent to the main hospital buildings. The CRU facility is open Monday through Friday during business hours and is staffed by a nurse, a medical technologist, and a business manager. The unit is 2,382 sq ft, all dedicated for outpatient services, and includes a waiting room, 4 examination rooms, a laboratory area for sample processing and storage, an area for charting by staff and investigators, office space for patient scheduling and follow-up, and an interview/conference room for long patient interviews, staff in-services, and investigator meetings.
The Brownsville CRU encourages inquiries from investigators who wish to conduct their own studies in its Hispanic community or to participate in ongoing studies in the CRU. The following ongoing studies in the CRU are open to other investigators:
- Cameron County Hispanic cohort.
This is a cohort of 2000 randomly selected individuals in the community. There is extensive socioeconomic, family history, and clinical data (including mental health data) on the subjects. Biological specimens have been collected for metabolic, genetic, molecular, and immunological assessment. This cohort is available for studies ranging from epidemiological studies of prevalence, clinical aspects, and basic mechanisms of disease in Mexican-American populations to evaluation of intervention strategies (including vaccines) to behavior modification.
- Early onset of diabetes cohort.
This is a cohort of more than 50 patients who were diagnosed with type 2 diabetes before the age of 30 (including 23 diagnosed at 18 or younger) and their immediate family members. This cohort is available for behavioral, genetic, clinical, and epidemiological studies of early-onset type 2 diabetes.
- School studies.
Several programs in local schools focus on obesity, insulin resistance, and obesity and diabetes prevention.
- Tu Salud, Si Cuenta!
This is community outreach program uses behavioral journalism to transmit messages to the community by TV, radio, and newspapers. It is extensively evaluated and is supported by a network of promotoras.
- Tuberculosis and diabetes.
This is an extensive field and laboratory program that includes a number of studies. Patients with tuberculosis are being recruited in three busy clinics, two in Texas and one in Matamoros, Mexico. Epidemiological, sociodemographic, and medical histories are collected. Biological specimens are taken for molecular and immunological studies to elucidate the immunological mechanisms that make diabetes patients particularly susceptible to tuberculosis. Patients are followed throughout treatment.
- Cervical cancer studies.
In the Lower Rio Grande Valley, the rates of cervical cancer are among the highest in the United States, and patients are being seen at increasingly young ages, even in their teens. Retrospective and prospective studies are under way to characterize the epidemiology of cervical dysplasia in this community and to determine whether, as is suspected, poor control of glucose metabolism contributes to the high rate of cervical cancer. Planned studies include testing of a new HPV vaccine (in conjunction with the Memorial Hermann CCTS CRU and Baylor College of Medicine) and studies of treatment of gestational diabetes, a major complication of pregnancy in this population.
For more information on these studies, on conducting other studies in the Brownsville CRU, or on the Brownsville CRU in general, see http://www.hhrc.info/ or contact Christina Villarreal (Christina.Villarreal@uth.tmc.edu) 956-882-6677. To use the Brownsville CRU, investigators must complete the UTHSC-H iRIS/CCTS application UTHSC-H iRIS/CCTS application.
The CCTS CRU activities at M. D. Anderson Cancer Center comprise the Clinical and Translational Research Center (CTRC) and the Phase I Clinical Trials Program in the Department of Investigational Cancer Therapeutics.
Clinical and Translational Research Center (CTRC)
Director: Daniel D. Karp, MD
Contact person: Monica Wyles (email@example.com) 713-563-0359
The CTRC is a 6,500 sq. ft., 15-room (16-bed) outpatient unit dedicated to innovative clinical research and new drug development. The unit began operations in 2002 and is located on the 10th floor of M. D. Anderson’s Clark Clinic Building. The CTRC provides sophisticated nursing care; phlebotomy services for pharmacokinetic studies; pharmacy services; a laboratory for specimen collection, preparation, and storage; and administration of therapy for clinical research studies. Assistance with development of clinical protocols and their budgets is also available. The unit is open 24 hours a day Monday through Friday and by appointment on weekends. The CTRC gives priority to Phase I and Phase II studies, but other studies can be conducted in the unit.
For more information or to use the CTRC, please contact Monica Wyles (firstname.lastname@example.org) 713-563-0359
Phase I Clinical Trials Program in the Department of Investigational Cancer Therapeutics
Director: Razelle Kurzrock, MD
Contact person: Doriel Ward , MPH, PhD (email@example.com) 713-563-0803
The Phase I Clinical Trials Program in the Department of Investigational Cancer Therapeutics consists of clinical and translational scientists, research nurses, study coordinators, clinical research fellows, and others who develop and perform innovative early clinical trials. The program emphasizes novel agents, unique studies, and hypothesis-driven clinical research. The program’s mission is to be a resource for the performance and coordination of high-impact, innovative Phase I trials. Although many Phase I and Phase I/II trials are sponsored by the pharmaceutical industry, early trials are a financial gamble for pharmaceutical companies, and many prefer to concentrate on studies of agents with proven efficacy that will soon yield a financial return. Identifying small subgroups of patients as responders and studying uncommon diseases and mechanism of drug action often require pioneering technologies and investigator-initiated endeavors. In addition, some Phase I trials for complex diseases must involve new combinations of approved or experimental drugs, and if the drugs are manufactured by different companies, the companies can be loath to invest in trials of drug regimens that include their competitors’ products. This, combined with the industry’s preference to fund trials for common diseases, hinders the implementation of
See also the M. D. Anderson Phase 1 website
the most innovative early clinical trials. The Phase I Clinical Trials Program was instituted to overcome these barriers and so to identify as rapidly as possible the best possible treatments for complex diseases. The group meets weekly to discuss current trials in the program and to enroll patients who might benefit from participating in a trial. At the end of a trial, plans are made to assure that progression to Phase II occurs in a rapid and seamless fashion.
For more information on the Phase I Clinical Trials Program or to find out how to participate, please contact Doriel Ward, MPH, PhD (firstname.lastname@example.org) 713-563-0803.