I. For Patients
What is a Clinical Trial?
A scientific test of the effectiveness and safety of a therapeutic intervention (as a drug, surgery, procedure, device, or vaccine) using consenting human subjects. Clinical trials can also test new uses of drugs or treatments that are already approved by the Food and Drug Administration for a specific use. Clinical trials are carried out under strict guidelines with great attention to measures of safety.
Should You Participate in Clinical Research?
People participate in clinical research for a variety of reasons. People who volunteer for clinical trials may gain access to promising drugs before these compounds are approved by the Food and Drug Administration for the marketplace. Others choose to participate as a way to advance science.
As a patient, your rights and safety are protected in two important ways. First, any physician awarded a research grant by a pharmaceutical company or the Federal Government must obtain approval to conduct the study from an Institutional Review Board (IRB). The IRB, which is usually composed of physicians from different specialties as well as people with no formal science training, is charged with examining the study's protocol to ensure that the patient's rights are protected, and that the study does not present an undue or unnecessary risk to the patient. Second, anyone participating in a clinical trial in the United States signs an "informed consent" form. This form details the nature of the study, the risks involved, and what may happen to a patient in the study. The informed consent tells patients that they have a right to leave the study at any time.
Patients considering participating in clinical research should talk about it with their physicians and medical caregivers. They also should seek to understand the credentials and experience of the individuals and the facility involved in conducting the study.
Other Questions to Ask the Study Coordinator or Physician Include:
- How long will the trial last?
- Where is the trial being conducted?
- What treatments will be used and how? What is the main purpose of the trial?
- How will patient safety be monitored? Are there any risks involved?
- What are the possible benefits?
- What are the alternative treatments besides the one being tested in the trial?
- Who is sponsoring the trial?
- Do I have to pay for any part of the trial?
- What happens if I am harmed by the trial?
- Can I opt to remain on this treatment, even after termination of the trial?
- What happens to me when the study is over?
II. For Sponsors
Our Patient Community:
The University of Texas Medical Branch at Galveston, is a major academic health science center dedicated to education, patient care, research and community service. UTMB is a health care system comprising 6 hospitals, an affiliation with one of only seven Shriners Burns Hospitals located in North America, 101 campus-based clinics and 37 community-based clinics that serve the needs of patients from 223 counties. UTMB is also home to a Ronald McDonald House, which serves as a home-away-from-home for the parents and families of children hospitalized with serious or long-term illnesses. During Fiscal Year '00, UTMB recorded:
- 32,505 - Inpatient Admissions
- 700,067 - Outpatient Clinic Visits
- 67,764 - Emergency Room Visits
- 11,344 - Telemedicine Consultations
- 4,000+ - Deliveries
Our community network provides for a rich diversification from which to draw our patients. Ethnicity, gender and age break down as follows:
- 55% Caucasian
- 23% Hispanic
- 17% African American
- 5% Other
- 60% Female
- 40% Male
- 25% Under 14 Years
- 11% Over 64 Years
Specific areas of clinical trial expertise with experienced Principal Investigators include:
- AIDS / HIV / STDs
- Asthma / Allergy / Immunology
- Behavioral Disorders
- Critical Care
- Emergency Medicine
- General Surgery
- Hematology / Oncology
- Infectious Disease
- Obstetrics and Gynecology
- Orthopedic Surgery
- Physical Rehabilitation
- Radiation Therapy
- Sleep Disorders
- Surgical Oncology
- Transplant Surgery
- Vascular Surgery
- Wound Healing
Specialized Equipment Programs:
UTMB also is home to some unique facilities and programs that support clinical research. These special features include:
- General Clinical Research Center
- National Institutes of Health AIDS Clinical Trial Unit
- National Institutes of Health Asthma Center
- Adult Burn Unit
- Aerospace Medicine
- Clinical Pathology Lab
- Hyperbaric Chambers
- Level I Trauma Center
- Palliative Care Program
- Renal Dialysis Unit
- Cath Lab (All Digital)
- Infant Special Care Unit
- High Risk Labor and Delivery Unit
- Labor / Delivery Recovery Post Partum
- Medical and Surgical Intensive Care Units
- Open Gates Dyslexia Program
- Kidney, Liver, Heart, Lung, Pancreas, Cornea Transplant Program
- Research Pharmacy
- Sealy Center on Aging
- Sealy Center for Cancer Cell Biology
- Shriners Burn and Crippled Childrens Hospital
- Texas Department of Criminal Justice Hospital
- Youth Psychiatric Program
- WHO Center for Tropical Diseases
- Sleep Lab
- Stark Diabetes Center
III. For UTMB Faculty & Staff
Sponsored Research Workshop Series:
SPONSORED RESEARCH WORKSHOP
Research Services, through the Office of Research Education, is pleased to sponsor a Clinical Research Workshop Series for the purpose of developing the professional skills of UTMB Investigators and Grant and Clinical Coordinators, and promote networking within our research community. “Sponsored Research Workshop Series ” meets monthly, from 11:30 to 1:30 p.m. in the Rebecca Sealy Hospital, Room 4.302.. Please click here to view the monthly meeting dates. Please bring your lunch and join us. Informal, interactive discussions cover research resources, and integral aspects of research coordination and administration. These sessions are led by experienced research faculty and university administrators, who make a short presentation on the given topic and then open the session for questions and answers. All interested individuals are encouraged to attend and participate.
Monthly reminders and any schedule updates are communicated via the Research Listserv, Daily Announcements and the Yellow Sheet.
(DHHS F&A Rate Agreement, Legal name, Tax status, EIN, etc.)