Addressing High Priorities for Stroke Research

As the Nation’s primary supporter of basic and clinical stroke research, NINDS strives to pursue the most pressing and promising scientific opportunities.  To help shape the direction of stroke research, NINDS has been engaged in a two-year planning process to identify the highest priority research areas for stroke prevention, treatment and recovery.  The resulting recommendations represent input from a broad community of researchers, clinicians and patient advocates (www.ninds.nih.gov/strokepriorities). The first major implementation effort, development of a new Stroke Trials Network, was approved by the National Advisory Neurological Disorders and Stroke (NANDS) Council on January 31 for launch in 2013.

Arriving at a Set of Priorities

The current stroke planning effort began in 2011 with a comprehensive analysis carried out by the Stroke Progress Review Group (PRG), an external group of prominent stroke scientists, clinicians and consumer advocates who have been working with NINDS on stroke research since 2001. The most recent recommendations from the PRG (http://www.ninds.nih.gov/find_people/groups/stroke_prg/01-2012-stroke-prg-report.htm) will guide the full gamut of stroke research supported by NINDS and conducted by the community. In addition, NINDS asked the community to identify the highest priority areas each for stroke prevention, treatment, and recovery research in a new type of priority-setting process based on independent ratings, proposal refinement, and repeated anonymous voting and discussion which was overseen by a Steering Committee.

To arrive at just a few priorities, NINDS asked members of the public and the research community to submit ideas regarding scientific opportunities for which significant, community-based effort and focus could lead to major advances over the next five to ten years.  Working groups on prevention, treatment and recovery independently rated over 180 submissions on impact, feasibility, need for targeted NINDS investment, and overall merit, and selected their top priorities.  At the end of the meeting, nine high-priority research areas were presented to the Steering Committee and NINDS staff.  The priorities are:

Crosscutting

• Accelerating the Translation of Stroke Research in Preclinical Animal Models into Clinical Studies of Highly Promising Treatments

Prevention

• Prevention of Vascular Cognitive Impairment
• Imaging Biomarkers in Stroke Prevention: From Bench to Bedside
• Expediting High Priority Comparative Effectiveness Trials in Stroke Prevention

Treatment

• Integrate and Expand Existing Stroke Trial Networks to Accelerate Translation
• Preclinical and Clinical Studies to Improve Early Reperfusion Therapy and Establish the Limitations of Late Reperfusion Therapy
• Preclinical and Clinical Studies to Achieve Robust Brain Protection

Recovery

• Translational Research Using Neural Interface Devices for Stroke and Other Neurologic Disorders            
• Program for Translational Research Targeting Early Recovery after Stroke in Humans   

Implementation: Responding to Infrastructure Needs through a Stroke Clinical Trials Network

Informed by the recommendations from the Stroke PRG, the Stroke Research Priorities Meeting, and by input from the NANDS Council, NINDS is actively moving forward with new stroke-focused efforts.  While not all of the proposed priorities can be addressed immediately with special initiatives, NINDS is implementing them as resources allow, beginning with a new Stroke Clinical Trials Network.

The need for improved clinical trial infrastructure resounded in each of the stroke priority working group discussions.  Evaluating new clinical interventions has been challenging and required substantial investments of time and money.  In addition to multidisciplinary scientific and clinical teams, clinical trials require significant resources for protocol development, regulatory review, patient recruitment and data management.  NINDS currently supports a large number of multi-site stroke clinical trials, some through consortia or networks, but most as stand-alone trials. 

Establishing shared infrastructure and protocols would allow for coordinated prioritization of studies, reduce duplicative study start-up efforts, enable comparison among studies, and improve efficiency. In response to these needs NINDS is establishing a Stroke Trials Network to develop and conduct high-quality, multi-site clinical trials of key interventions in stroke prevention, treatment and recovery. 

The Network will comprise a geographically distributed system of Clinical Sites, a Clinical Coordinating Center, and a Statistical and Data Management Center and bring together scientific and clinical trials expertise and enable nation-wide subject recruitment for phase II and phase III trials.  Strong multidisciplinary collaboration within and among sites will ensure successful trial completion. A steady pipeline of new trials developed outside as well as within the Network, and facilitated international and private-public partnerships will all serve to enhance the public health impact of the NINDS’s investment in stroke clinical trials.

The Institute values input received from the community in these planning efforts, which are vital to achieving our mission of reducing the burden of neurological disorders and stroke.  We will continue to engage the broad community of stroke researchers, clinicians and patient advocates as the Network takes shape and as we implement other priorities identified through our stroke planning efforts.