The proposed StrokeBelt StrokeNet (SBSN) RCC will benefit from the established infrastructure, basic science and clinical stroke expertise, and stroke clinical trial experience at UAB, and work with established partner institutions in the Southeastern US, including Children?s of Alabama, the UAB/Lakeshore Research Collaborative, the University of Mississippi Medical Center, and the University of South Alabama. Each institution has its own network of referral hospitals, clinical trial infrastructure and experience enrolling in stroke clinical trials. The result is that a large part of the Stroke Belt will have access to StrokeNet Clinical Trials. The SBSN will succeed by leveraging key attributes of our region and network. First, the SBSN RCC will offer combined access to nearly 3,500 acute stroke patients annually, many of them minorities, in an underserved part of the US. As in our NeuroNext program, we will aggressively pursue the inclusion of underrepresented and minority populations in our clinical trials through collaboration with the Minority Health and Health Disparities Research Center (MHRC) and Strengthening Translational Research in Diverse Enrollment (STRIDE). Second, UAB and its partners have a track record of patient? oriented stroke research and successful stroke clinical trial recruitment. Over the last 3 years, UAB alone has participated in 20 NIH? or industry?sponsored multicenter phase 1, 2 and 3 trials in stroke treatment, prevention, and recovery, enrolling 401 patients. We were nationally?leading recruiters in the TUCSON, CUFFS, CLOTBUST?HF, SAMMPRIS and CLEAR III trials. We actively enrolled in the first StrokeNet trial, DEFUSE3, are currently enrolling in CREST?2, and preparing for participation in ARCADIA and CREST?H. We are the leading recruiting center in MyRIAD and the second leading center for MISTIE III. Over the last 3 years, SBSN institutions/investigators have participated in a total of 37 trials in stroke treatment, prevention, and recovery, and enrolled a total of 2050 subjects. Third, we have extensive experience in stroke recovery with specific expertise in stroke?related aphasia recovery/rehabilitation, TMS and imaging, motor recovery, tele?rehabilitation and robotics. Fourth, our proposed network will be strengthened by the already?strong connections between the UAB Center for Clinical and Translational Science (CCTS) and our partner institutions. All of the institutions in our proposed network are already our partners, and already have experience with master IRB reliance agreements. Fifth, our research program will build upon our already?successful recruitment by applying a performance improvement approach to enhance clinical trial screening, enrollment and retention. Strategies include specific screening, enrollment and retention methods; rigorous and continuous monitoring and performance improvement of trial implementation and subject screening, enrollment and retention; training and sharing of best practices; and programs to enhance engagement and enthusiasm of investigators and coordinators across the network. Sixth, the training of stroke clinical scientists at UAB will be enhanced through programs developed with the UAB CCTS and UAB School of Public Health (SOPH).

Public Health Relevance

The proposed StrokeBelt StrokeNet (SBSN) RCC has a robust network of institutions with access to a large population of potential subjects, many of them minorities, in an underserved part of the US, a track record of successful enrollment in stroke clinical trials, a rich community of basic science and translational stroke researchers, and an extraordinarily collaborative environment with the desire to contribute to the StrokeNet effort.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Resource-Related Research Projects--Cooperative Agreements (U24)
Project #
5U24NS107223-03
Application #
9999052
Study Section
Special Emphasis Panel (ZNS1)
Program Officer
Vivalda, Joanna
Project Start
2018-08-15
Project End
2023-07-31
Budget Start
2020-08-01
Budget End
2021-07-31
Support Year
3
Fiscal Year
2020
Total Cost
Indirect Cost
Name
University of Alabama Birmingham
Department
Neurology
Type
Schools of Medicine
DUNS #
063690705
City
Birmingham
State
AL
Country
United States
Zip Code
35294