Our SPOTRIAS Program Project includes 3 clinical research subprojects, consisting of novel therapeutic interventions. All of these trials are phase 1 or 2 in their development, and have been conceptualized and designed by our group. One is brand new, and two are the next phase of projects begun during our first SPOTRIAS. The purpose of the Clinical Core is to facilitate this work. The conduct of such clinical trials is complicated requiring careful planning, expert execution, close supervision, detailed monitoring, and complex data analysis. To carry out such research requires excellent clinical facilities, ample patients, collaborative relationships and the skills of experienced investigators, nurse coordinators, and administrative staff. Special problems are inherent in conducting clinical trials that are investigator-initiated since these studies usually do not have the backing of a large funding agency or pharmaceutical company, at least in their early stages, to provide the financial and administrative support to carry out this work. The purpose of this Clinical Core is to improve the capability of orchestrating such early stage research within the Vascular Neurology (VN) Program at the University of Texas Houston Medical School. As a large, well-established Stroke Center with a thriving fellowship training program, we have been conducting investigator-initiated phase 1 and 2 clinical research for many years and have made progress with many challenges inherent in this work. The clinical collaborations, study conduct, and administration of our VN Program that evolved over its first 15 years has been substantially enhanced by the overall administrative structure, plan and central coordination provided over the past 5 years by the SPOTRIAS Clinical Core.
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