Founded in 2002, the Stroke Sciences Group (SSG) is an active division of the Department of Neurology at the University of California, San Francisco. The group's overall goal is to study the epidemiology and natural history of neurovascular disease, and then apply this knowledge to the development of management strategies. As an academic research organization with over 10 years of experience coordinating domestic and international multicenter drug and device clinical trials and observational studies, we work closely with the UCSF Clinical and Translational Science Institute (CTSI) and the San Francisco Coordinating Center (SFCC). SSG has been responsible for launching and coordinating many complex multicenter studies funded by the NIH, industry, and the CDC. Examples of supported projects include:
- Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial: An ongoing international study of 4150 patients with acute minor stroke or TIA at 200 centers worldwide funded by NIH. Role: principal leadership, all planning, communication strategy, site selection, clinical outcome adjudication, investigator and study personnel training, statistical analysis plan, committee management, results presentation, central pharmacy, secondary studies coordination.
- Vascular effects of infection in Pediatric Stroke (VIPS) Study: An ongoing observational study of 480 children with stroke seen at 40 centers worldwide funded by NIH. Role: principal leadership (shared), all planning, site selection, outcome adjudication, image management and adjudication, statistical analysis, committee management, results presentation, secondary studies.
- Quality Improvement in Stroke Prevention (QUISP) trial: A completed trial of stroke secondary prevention involving 4000 patients at 16 sites in Northern California. Role: principal leadership, all planning, site selection, site management, investigator training, outcome adjudication, statistical analysis, committee management, results presentation, secondary studies.
- Matrix and Platinum Science (MAPS): A recently completed international multicenter trial of 630 subjects receiving two types of coils to treat intracerebral aneurysms funded by Strkyer. Role: principal leadership (shared), neuroimaging core lab services, protocol development, image review and outcome adjudication, investigator training, statistical analysis plan, committee management, results presentation, secondary studies.
- California Acute Stroke Pilot Registry (CASPR): A completed observational study of 764 patients with ischemic stroke at 11 hospitals in California. Role: principal leadership, all planning, site selection, site management, investigator training, outcome adjudication, statistical analysis, committee management, results presentation, secondary studies.
- Clopidogrel in Acute Stroke and Transient Ischemic Attack (CASTIA): An international trial of 2000 patients with acute minor ischemic stroke or TIA at 150 hospitals worldwide sponsored by sanofi-aventis and Bristol-Myers Squibb. (The trial was canceled after the initial investigators meeting.) Roles: principal leadership, protocol development, statistical analysis plan, committee management, investigator training.
We are a team of 20 physicians, scientists, nurses, clinical research coordinators and biostatisticians. In addition to our Core group, we have a large network of partnered specialists who are available when additional expertise is needed for a project. Our internationally recognized leaders include S. Claiborne Johnston, Wade Smith, J. Donald Easton, and Heather Fullerton, who have led many multicenter studies.
We specialize in the disease areas of adult ischemic stroke and TIA, pediatric stroke, cerebral aneurysms and vascular malformations.Â The SSG has a proven track record in protocol development, site selection, subject recruitment and retention, site coordination/ monitoring, data collection, data management, data analysis, neuroimaging systems and process management, adjudication, committee oversight, and publications.
We provide services in the following areas:
- Trial design
- Protocol development
- IRB/CHR liaison
- Preparation of study budget; partner contract reviews
- Formation, chairing, and convening major committees
- Attending meetings with FDA, other oversight bodies
- Statistical analysis plan
- CRF design
- Development of Manual of Procedures
- Identification of potential high-enrolling sites
- Development of informed consent
- Development and implementation of training materials and sessions for investigators
- Preparation of subject materials, study collateral
- Oversight of study initiation activities
- Standard Operating Procedures (SOP) library
- Trial leadership
- Leadership, support, and oversight of major committees
- Ongoing advice on study design, conduct, and reporting
- Site communications regarding clinical/complex trial-related issues (emergent or as secondary layer of response)
- Site communications regarding recruitment, FAQs, newsletters
- Preparation of a manuscript describing the study design
- Preparation of final manuscript
- Presentation of results at major meetings (and assisting others with preparation)
- Assistance with preparation of manuscript describing ancillary studies
- Data management/statistical analysis
- Implementation of database/data entry system (FDA compliant, allows for fax and EDC)
- Adjudication of clinical outcomes
- Coordination of imaging
- Adjudication of imaging
- Ongoing statistical reports to DSMB and study leadership
- Interim data analysis to DSMB
- Final analysis
- Analysis for ancillary studies