Five Things You Need to Know about NIH StrokeNet in Five Minutes

Transcription

1 Five Things You Need to Know about NIH StrokeNet in Five Minutes Joseph P. Broderick, MD Department of Neurology University of Cincinnati Neuroscience Institute Comprehensive Stroke Center

2 Financial Disclosures Study medication for NINDS studies from Genentech (two trials) and Schoering- Plough/Merck (one). Research monies from Genentech for PRISMS Trial Executive Committee Travel to Australian stroke conference paid for by Boerhinger Ingelheim

3 Maximizing efficiencies in cerebrovascular research National Coordinating Center: NINDS 1U01NS

4 1) The NIH StrokeNet is Something New for U.S. National Network that includes stroke prevention, acute treatment, and recovery trials. Multi-site Phase 1 to Phase 3 Trials, biomarkers studies. Centralized infrastructure for contracts, IRBs, managing data, and running trials. Big 25 regional centers and over 200 associated hospitals thus far.

5 National and Regional Coordinating Centers UW Medicine/ Harborview Med. Ctr. U Minnesota RCC Chicago Stroke Trials Consortium NIH Cleveland Stroke Trials Collaborative NorCal Research RCC Stanford Stroke Center U Utah RCC U Iowa RCC U Wisconsin RCC Michigan StrokeNet Ohio State WexnerRCC U Cincinnati RCC UPMC Stroke Institute New England RCC Stroke Trials Network of Columbia and Cornell NY City Collaborative RCC G. Philadelphia NIH StrokeNet Stroke National Capital Area Network for Research Los Angeles-So. California Regional NIH StrokeNet UCSD Stroke Center Vanderbilt U Medical Ctr Georgia StrokeNet So. Caroline Collaborative Alliance for Stroke Trials Gulf Regional Area Stroke Programs Miami RCC Census Region: West Midwest South Northeast

6 Regional Coordinating Centers funded by NINDS (RCCs) Site # R01 R02 R03 R04 R05 R06 R07 R08 R09 R10 R11 R12 Site CASE WESTERN RESERVE UNIVERSITY COLUMBIA UNIVERSITY HEALTH SCIENCES EMORY UNIVERSITY MASSACHUSETTS GENERAL HOSP MEDICAL UNIVERSITY OF SOUTH CAROLINA MEDSTAR RESEARCH INSTITUTE NEW YORK CITY COLLABORATIVE REGIONAL COORDINATING CENTER NORTHWESTERN UNIVERSITY AT CHICAGO OHIO STATE UNIVERSITY STANFORD UNIVERSITY UNIVERSITY OF CALIFORNIA LOS ANGELES UNIVERSITY OF CALIFORNIA SAN DIEGO

7 Regional Coordinating Centers (RCCs) Site # R13 R14 R15 R16 R17 R18 R19 R20 R21 R22 R23 R24 R25 Site UNIVERSITY OF CALIFORNIA SAN FRANCISCO UNIVERSITY OF CINCINNATI UNIVERSITY OF IOWA UNIVERSITY OF MIAMI SCHOOL OF MEDICINE UNIVERSITY OF MICHIGAN UNIVERSITY OF MINNESOTA UNIVERSITY OF PENNSYLVANIA UNIVERSITY OF PITTSBURGH AT PITTSBURGH UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON UNIVERSITY OF UTAH UNIVERSITY OF WASHINGTON UNIVERSITY OF WISCONSIN-MADISON VANDERBILT UNIVERSITY MED CTR

8 2) Trial Protocols Can Come From Within and Outside of NIH StrokeNet Process includes Submission of formal trial proposal to NINDS Assessment of feasibility (multiple aspects) by NIH StrokeNet NIH review and eventual approval Opportunity to minimize competition between trials and develop pipeline for rapidly starting new trials Balance of Acute, Prevention, and Recovery Trials Industry encouraged need NIH review RFA for types of trials best suited for NINDS strategic goals and NIH StrokeNet Spring, 2014.

9 3) Education is Key Component of NIH StrokeNet Educational Core Funding for fellows at each RCC. Educational for fellows, coordinators, and physicians who are part of network. Formal lectures, interactive sessions, and training for a given trial.

10 4) Large Trials Run Through Network Will Likely Need More Sites than RCCs and Satellites Hospitals not affiliated with RCC Other non-us national networks (example Canada) participating in global trials Based upon needed sample size and availability of potential trial subjects

11 International Networks Are Needed for Large Phase III Trials

12 5) NIH StrokeNet Structure Has Just Started and Is Evolving Getting Master Trial Agreements and Reliance Agreements for cirb approved Governance structure as Data Management Center at Medical University at South Carolina is integrated Website Initial trials to be done are under discussion

13 National Coordinating Center Toll Free Number NIH StrokeNet Website

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15 NIH StrokeNet Leadership and Governance

16 Executive Committee Function: Strategic Network Leadership and overall network management. NIH StrokeNet Executive Committee Members: NINDS Scientific Program Director: Scott Janis, PhD NCC PI: Joseph Broderick, MD DMC PI: TBN NCC Staff: Pooja Khatri, MD, Thomas Brott, MD, Steve Cramer, MD, Laura Sauerbeck, Judith Spilker, 3 rotating RCC members Non-Network adjunct members (from other Stroke consortia); working and core groups as needed

17 Steering Committee Main scientific governing body of the network. All major network decisions will be made by a majority vote. All decisions must be concurred by NINDS leadership. Membership: NINDS: Scott Janis, PhD NCC PI: Joseph Broderick, MD DMC PI: TBN PIs of all 25 RCCs

18 Operations Committee Function: Oversees network operational issues (including MTAs, RAs and other agreements) and monitors trial performance. Members: NINDS Joanna Vivalda NCC PI Joseph Broderick, MD Trial Specific PIs NINDS Project Program Directors and/or trial specific designees Key NCC and DMC staff

19 NIH StrokeNet Working Groups by Domain

20 NIH StrokeNet NCC Cores

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