STAIR IX
Stroke Treatment Academic Industry Roundtable

October 5-6 2015
Bethesda, MD
 

"Acute Stroke Trials: Advancing Design,

Regulation and Implementation"

 

STAIR IX Program      STAIR IX Sponsors    Presentation Slides    

Consensus Recommendations

 

About STAIR IX

STAIR IX will be convened on October 5-6, 2015 at the Bethesda Marriott Hotel in Bethesda, Maryland (Wash. DC area). Over sixty of the world’s leading stroke research neurologists and neuroradiologists will actively participate in STAIR IX. They will be joined by an equal number of scientists and business leaders from pharmaceutical and device companies. Rounding out the consensus conference attendance will be a large delegation of high level staff from NIH-NINDS and the FDA including CDER and CDHR branches.

In the day one prologue to the consensus recommendations developed during the second day of STAIR conferences, updates on state-of-the-art current stroke treatment approaches as well as prospective new therapies on the horizon are presented to help identify and focus on issues to be addressed in the recommendation development portion of the STAIR consensus conference. These and related issues form the themes around which recommendations will be generated that are intended to improve the R & D process from medical/scientific, regulatory and business perspectives.

STAIR designates large blocks of time following formal presentations in each topic session for questions and discussion. A panel of experts representing the three sectors of academia, government and industry takes the stage, after presentations in each session are completed, to pose questions to presenters and discuss information presented and issues posed. Open, candid dialogue is facilitated by session co-chairs who invite questions and dialogue from participants in the audience as well as presenters and panelists. These discussions allow complex issues to be rigorously explored via the knowledge, experience and perspective represented by and contributed from the diverse constituency of STAIR participants.

STAIR IX Major Sessions and Presentations:

  • ACUTE STROKE TRIALS: NEW DATA, NEW LANDSCAPE, NEW DESIGNS

  • HARNESSING CRITICAL MASS TO STRENGTHEN DATA COLLECTION/ANALYSIS AND INFLUENCE GUIDELINES/REGULATORY

  • STIR IMAGING I: ROLE OF IMAGING IN RECENT CLINICAL TRIALS

  • STIR IMAGING SESSION II: IMAGING CONSIDERATIONS FOR TRIAL DESIGN

  • REGULATORY PERSPECTIVE ON CLINICAL TRIAL ISSUES: IMAGING-BASED

SELECTION, REGULATIONS AND RELEVANT POLICIES

STAIR IX Themes to be Addressed and Developed into Consensus Recommendations:

  • THE NEXT GENERATION OF ENDOVASCULAR TRIALS

  • IMAGING WORKSHOP: ORGANIZE A TRIAL TO COMPARE IMAGING MODALITIES

TO SELECT PATIENTS FOR ACUTE STROKE TREATMENT

  • ACADEMIC AND INDUSTRY SPONSORED TRIALS

For complete information on sessions and presenters, consult the STAIR IX Program.

STIR and ASNR Collaboration with STAIR IX

The Stroke Imaging Repository (STIR) Consortium together with the Academy Society of Neuroimaging (ASNR)Foundation are collaborating with the STAIR organization to advance the development of meaningful recommendations covering important neuroimaging issues are developed and become part of the STAIR IX publication.

About the STIR Consortium

In September 2007, the National Institute of Health, in conjunction with the American Society of Neuroradiology and the Neuroradiology Education & Research Foundation, sponsored a research symposium entitled Advanced Neuroimaging for Acute Stroke Treatment. That meeting brought together stroke neurologists, neuroradiologists, emergency physicians and neuroimaging research scientists to discuss the role of advanced neuroimaging in acute stroke treatment.

One of the recommendations was the creation of an international consortium of investigators – the Stroke Imaging Repository - to combine efforts to promote excellence in stroke care and stroke trial design and more specifically to overcome the issues faced by advanced stroke imaging, as mentioned earlier.

This central repository was designed to work in collaboration with two other collaborative groups, VISTA (Virtual International Stroke Trials Archive) and MR Stroke. VISTA is an international collaborative venture that was established to facilitate the planning of randomized clinical trials and collects and gathers datasets from multiple institutions. The VISTA database provides the possibility to access a large volume of patient data on which to perform original analyses that would ultimately aid clinical trial design and development.MR Stroke is a collaborative effort between leading clinicians and clinical scientists around the world with a common interest in Magnetic Resonance Imaging in Stroke. MR Stroke is intended to facilitate the sharing and exchange of information and ideas, to facilitate access to a range of web based MR imaging tools and resources relevant to stroke, and to establish a forum for the exchange of information relevant to research using MR Imaging in stroke.

Overall STIR Goals

The overall purpose of STIR is to create a repository of source MRI and CT images that could be used towards the objectives of standardization and validation of image acquisition, of image analysis, and of clinical research methods for image-based stroke research. More specifically, the consortium was originally established to collect and provide a rich resource of patient datasets in order to contribute meaningful information regarding the goals listed above:

  1. Standardization of perfusion and penumbral imaging techniques

  2. Validation of the accuracy and clinical utility of imaging biomarkers of the ischemic penumbra

  3. Validation of imaging biomarkers relevant to clinical outcomes