Our SPOTRIAS Program Project includes 3 clinical research subprojects, consisting ofnovel 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 twoare the next phase of projects begun during our first SPOTRIAS. The purpose of theClinical Core is to facilitate this work.The conduct of such clinical trials is complicated requiring careful planning, expertexecution, close supervision, detailed monitoring, and complex data analysis. To carryout such research requires excellent clinical facilities, ample patients, collaborativerelationships and the skills of experienced investigators, nurse coordinators, andadministrative staff. Special problems are inherent in conducting clinical trials that areinvestigator-initiated since these studies usually do not have the backing of a largefunding agency or pharmaceutical company, at least in their early stages, to provide thefinancial and administrative support to carry out this work.The purpose of this Clinical Core is to improve the capability of orchestrating such earlystage research within the Vascular Neurology (VN) Program at the University of TexasHouston Medical School. As a large, well-established Stroke Center with a thrivingfellowship training program, we have been conducting investigator-initiated phase 1 and2 clinical research for many years and have made progress with many challengesinherent in this work. The clinical collaborations, study conduct, and administration ofour VN Program that evolved over its first 15 years has been substantially enhanced bythe overall administrative structure, plan and central coordination provided over the past5 years by the SPOTRIAS Clinical Core.
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