The long-term objectives and aims of this application focus on the development and rapid implementation of research, to enable a long-term sustainable model of high caliber enrollments into NIH trials. This is relevant to the NIH's mission of extending trial opportunities to more patients in more areas of stroke management. Program: UCSD has participated in NIH-SPOTRIAS, NIH, industry and self-funded trials in various areas of stroke and has now engaged the support of the Dean, Chair, IRB, Contracting Office, CTRI, ED, EMS, spokes and Co-Is for this proposal. UCSD has provided over 1,000 enrollments into trials, over 3,000 data records into repositories and over 500 samples into specimen studies. UCSD has now expanded its current network to include a total of 19 facilities enabling access to pediatric, rehab, and EMS patients and has enlisted the support of each spoke center to streamline clinical trial agreements and defer IRB oversight. Research: UCSD has participated in development of numerous trials in the past 25 years. A 5 year plan is in place to implement new NIH trials, expand trials into more centers, and develop high caliber scientific trials for the network. UCSD has now also developed a capacity for performing trials in pediatric stroke and rehab. Leadership: UCSD has designated a PI and substitute PI, each with qualifications to serve effectively in this role. In the multidisciplinary clinical trials' team, eperts from various disciplines are available to collaborate on trials in diverse arenas of stroke management. Trials are assigned based on area of expertise. Training Program: The Stroke Center maintains full commitment to career guidance for fellows. A fellowship has been in place since 1987, was enhanced in by SPOTRIAS, and now has been extended for this grant. Administration: Standard operating procedures (SOPs) guide all aspects of the center ranging from managing stroke codes to trial operations. UCSD uses a trial hierarchy which includes participating in research with high likelihood of patient benefit, strong partnerships and a focus on NIH trials. UCSD has an allocation plan in place at each of the 19 RCC centers to avoid bias or inclusion criteria overlap, and focus on populations at risk or with historically limited focus. UCSD is an ideal choice as an RCC for this network.
Developing a robust regional network of expertise in stroke trial design and performance is crucial to the NIH's mission of benefiting public health as it extends opportunities to more patients, in more diverse areas of stroke, to be enrolled into trials A robustly developed UCSD RCC that includes training, multispecialty care, network wide enrollment focus, would facilitate rapid trial enrollments while ensuring the sustainability for future vears of stroke research and stroke trained researchers.
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