About ARISE
ARISE: Aneurysm/AVM/cSDH Roundtable Discussion with Industry and Stroke Experts
Stroke is a leading cause of death and serious long-term disability worldwide, with an estimated global prevalence of over 104.2 million people. With about 6.2 million deaths attributed to cerebrovascular diseases annually, ischemic and hemorrhagic strokes remain major threats to public health. There is no indication that these numbers changed significantly despite advances in modification of risk factors and specific preventive treatment of some etiologic factors. One major challenge is the highly heterogenous nature of potential causes of stroke, which require a concerted multidisciplinary approach to design and conduct of clinical prevention trials. Albeit well-designed successful clinical trials have led to significant advancement of management of stroke victims, there is the need for improvement and conduct. Newer data on the epidemiology of these diseases and innovative solutions must be integrated in the management of these patients through better collaboration among the major stakeholders: academia, government-based funding and regulatory organizations, and industry.
Our mission
The ARISE Consensus Conferences, via a collaboration of medical academia, the healthcare industry and government agencies, are intended to advance and accelerate stroke research to ultimately result in improved stroke acute treatment, care, and prevention. To achieve this goal, ARISE will:
- Develop new approaches to overcome barriers impeding stroke drug and device development
- Discuss clinical trial designs for drug and device approval
- Identify, clarify, and communicate the implications of new research to the stroke field
- Publish the consensus recommendations of ARISE participants which address these concerns
- Promote adoption of ARISE solutions by research, industry, clinical and government communities
Who is involved
ARISE architecture thus includes all 3 stakeholders in brain aneurysm and brain arteriovenous malformation research and practice: academia (leading international physicians/scientists from all involved disciplines), industry (scientists and executives from private sector pharmaceutical, device, and imaging companies), and regulatory institutions (executive managers, physicians and scientists from NIH and FDA).
Program Agenda
ARISE will start with a full day meeting focusing on cutting-edge research study designs, analytic methods, novel drugs/devices, biomarkers, and outcomes. The sessions will cover new data and approaches on brain aneurysms, cSDH, bAVMm, as well as the regulatory perspective on key clinical trial issues.
The second day of ARISE will focus on the consensus process to develop recommendations. Participating experts from academia, industry and regulatory institutions will be divided into 2 groups for preparation of the consensus recommendations. They will be provided with equal opportunity to contribute to a facilitated discussion process, during which recommendations developed by leading academic thought leaders in brain aneurysms, cSDH and bAVM will be presented, openly discussed, and may be amended, expanded, replaced, and refined by the group. Each of the 2 content groups will then present their recommendations to the entire assembly. Writing committees will draft the manuscripts for review of the group and the resulting articles will then be published.
Funding
ARISE does not receive any government funding. The ARISE Roundtable is funded solely by participating private sector companies.