Participant and Clinical Interactions

The UTMB CTSA hub has promoted the conduct of high quality, novel human studies in nutritional interventions, space sciences, bionutrition and Phase I/II CTs.  Leading quality programs for C/T research, the CRC has applied of LifeWings in reducing research errors.  Its active bionutritionist program has formed the basis for the formation of a degree-granting Department of Nutrition and Metabolism at UTMB.

Current Human Subjects Research program. For over 52 years, UTMB has performed high-quality human research on a NIH-funded clinical research center (CRC). In 2002, an 8,320 sq. ft. Clinical Research Center (CRC) was renovated on the 5th floor of John Sealy Hospital with a NCRR construction grant ($855,000) matched by ~$2M from UTMB, assuring use of that space for research for 20 years. The unit has 8 inpatient rooms for multi-disciplinary research, including 2 negative pressure rooms suitable for studying infectious agents. There are 3 outpatient rooms for routine visits, 2 outpatient rooms with beds suitable for prolonged outpatient studies, and a phlebotomy room that can also be used for glucose tolerance tests and pharmacokinetic studies. There is a procedure room equipped as an OR suite (some protocols on this unit have required general anesthesia and invasive procedures), and an exercise room with a bed for exercise. The clinical sleep laboratory is in CRC space, and 2 of the 4 sleep rooms are equipped with wall ports to allow blood draws without waking the subjects during research sleep studies. There is an extensive array of equipment to measure body composition, (e.g., iDEXA body mass scanner, underwater weighing system, BODPODBodPod) or physiological function, (e.g., two metabolic control units for VO2 determinations and 2 Biodex units for isokinetic testing). Because of a significant volume of protocols requiring fixed composition diets, there is a fully equipped metabolic kitchen on the unit with an outpatient dining room. There is a Core Lab for specimen processing and mailing and for performing special assays (e.g., insulin or hormone assays). There are 3 special air-conditioned rooms for housing -80 degree freezers for our biorepository, and there are 2 conference rooms and offices.

In 2004, a NASA-funded unit was developed in the former CRC space on the 6th floor of the Children’s Hospital. This ~8,000 sq. ft. unit, the Flight Analog Research Unit (FARU), conducts research on a bed rest platform to serve as an analog for the physiological effects of weightlessness in space. It was founded based on cooperative agreements (Space Act Agreement) between UTMB and NASA and NCRR/NCATS and NASA . The unit consists of 5 inpatient rooms with double occupancy (10 same -sex subjects) and a metabolic kitchen (all subjects are on fixed composition diets). The unit contains offices and multiple testing or exercise rooms, some of which house special and unique exercise equipment that allows subjects to exercise in a recumbent position (e.g., vertical treadmill), and special testing equipment (e.g., recumbent cycle ergometry, T-reflex testing or neurosensory balance testing).

In the past five years, the CRC and FARU have participated in 165 protocols with a census of 8,775 inpatient bed days and 9,850 outpatient visits. As illustrated in the table below, the strengths of our clinical trials research are predominantly federal funding of protocols, predominantly phase 1 and 2 trials, many requiring pharmacokinetics, and a significant investment in special population or orphan disease research.

CLINICAL TRIALS on ITS– CLINICAL RESEARCH CENTERS
JULY 2009 – NOVEMBER 2014

Description No. of Trials Sponsor No. of Trials Special Population No. of Trials
Phase 1 115 Federal* 50 Elderly 30
Phase 2 19 NASA, NSBRI 8 Pediatrics 5
Phase 3 23 Industry 21 Orphan Diseases** 27
Phase 3-4 8 Foundation 10    
Multi Ctr 19 Local 33    
Pharmacokinetics 59        

Inpatient Bed Days:    8,775 (75 % on FARU)    *NIH, NIEHS, FDA, DOD
Outpatient Visits:         9,850 (99% on CRC)    **Porphyria, Primary Immunodeficiency, Hereditary Angioedema (HAE)