Multi-Site Study Support

Through the national CTSA network and the Texas Regional CTSA Consortium (TRCC), ITS is building upon UTMB’s strong track record of collaborative research. Our MTT construct is ideally suited to provide leadership to grow new multi-site clinical trials, and we have used the MTT model to significantly grow our portfolio in new multi-site NIH-funded trials in aging, burns injury/response, the metabolic syndrome and others. We have significant strengths in multi-site clinical trials in special populations, including geriatrics, pediatrics and pregnancy. We have completed recruitment of more than 1,000 hospitalized geriatric patients for two multi-site cohort studies, the ASPREE and STRIDE studies, and have been major recruitment sites in maternal fetal medicine. The pediatric-focused Burns injury MTT (D. Herndon, MD, PI), including faculty at the UTMB-affiliated Shriners Hospitals for Children – Galveston (SHC-G) Burn Hospital, is an international center of excellence for burn care and research, with the best survival statistics for pediatric burns and inhalational injury in the country (20). CTSA support led to a successful multi-site NIGMS-funded P50 CT (NIGMS P50 GM060338) to test their FDA Investigational New Drug (IND) for use of propranolol in the management of burn injury-induced hypermetabolic syndrome.

We are currently developing an integrated system for supporting Clinical Trial Working Groups by providing budgeting, quality assurance monitoring, study management, and coordinator support/training, positioning us for tremendous growth in all phases of clinical research. The campus-wide roll out of Velos and centralization of key clinical trial processes uniquely positions UTMB to streamline clinical research. Later this year, three of our partner TRCC sites will also deploy Velos. With the other TRCC institutions, we are establishing a coordinating center for the Texas Multi-Center Clinical Trial TRCC initiative. The four CTSA sites within Texas have reciprocal IRB agreements in place to facilitate clinical trial review. Staff in the centralized office coordinate this process and shepherd sites through each phase by assisting with document preparation and submission. The coordinating site leads all centralized functions including: medicare coverage analysis, budget negotiation, consent development, study calendar development within Velos, and regulatory document processing.