1. Coordinator Webinar and Round Table Discussion
July 25, 2018

2. Coordinator Call Announcements and Reminders
Next Coordinator Webinar :
Next Coordinator Call August 29th, 2018.
Sleep Smart Study Team will host the next round table discussion.
Today’s Roundtable Hosts: Scott Janis and Joe Broderick.
To join Coordinator Webinars: Please enter as a guest, then add your first and last name or address. For Audio: Dial-In Number: (877) Passcode
Upcoming StrokeNet Meetings:
Plan Ahead: Montreal World Stroke Conference, October 16th,
NCC will reimburse for one night stay at $250.

3. Project Updates TELE-REHAB
Closed to Enrollment:
Study Updates:
Study Project Managers: Lucy Dodakian, MA, OTR/L
Judith Spilker, RN, BSN
Study Investigator: Steve Cramer, MD
Data Manager: Kavita Patel

4. Project Updates i-DEF Closed to Enrollment: Study Updates:
Study Project Manager: Jessica Griffin
Study Investigator: Magdy Selim, MD

5. Project Updates DEFUSE 3
Closed to Enrollment:
Study Updates:
Study Project Manager: Stephanie Kemp, BS
Janice Carrozzella, MSN, CNP, RT(R), CCRA
Study Investigator: Greg Albers, MD
Data Manager: Jessica Griffin

6. Project Updates CREST 2 Study Updates:
Study Project Manager: Mary Longbottom, CCRP, CREST Director for Data Quality 
Study Investigator: Tom Brott, MD

7. Project Updates ARCADIA
Study Updates:
Study Project Manager: Irene Ewing, RN, BSN
Study Investigator: Hooman Kamel, MD;
Mitch Elkind, MD
Data Manager: Faria Khattak and Holly Pierce

8. Project Updates Sleep Smart
Sleep Smart PI: Devin Brown MD
Project Manager: Kayla Gosselin
Joelle, Sickler

9. Project Updates MOST Most: Project Manager: Teresa Murrell-Bohn
Iris Deeds

11. MOST Study Team Principal Investigators
(Lead) Opeolu Adeoye, MD, MS, University of Cincinnati
Andrew Barreto, MD, MS, University of Texas-Houston
Jim Grotta, MD, Memorial Hermann Hospital-Texas Medical Center, Houston
Joe Broderick, MD, University of Cincinnati
Colin Derdeyn, MD, University of Iowa
University of Cincinnati Clinical Coordinating Center
S. Iris Deeds, CCRP – Lead Trial Coordinator
NIH StrokeNet National Coordinating Center
Teresa Murrell-Bohn, RN, CCRC – NCC MOST Project Manager

12. Project Updates Recognized NIH Trials
That remain open to enrollments:
Study Updates:
SHINE
Project Manager: Heather Haughey

13. NCC/NINDS Updates NCC Staff Members: Joe Broderick, PI
Jamey Frasure, Co-Director Judith Spilker, Co-Director
Sue Roll, CIRB Liaison Keeley Hendrix, CIRB
Diane Sparks, Contracts Jeanne Sester, Training Coordinator
Mary Ann Harty, Finances Rose Beckmann, Administration
Joanna Vivalda, NINDS Scott Janis, NINDS

14. Data Management Center Updates
WebDCU/MUSC Team: Yuko Palesch, PI Wenle Zhao, PI Catherine Dillon, Operations Mgr. Jessica Griffin, Project Mgr.

15. CIRB Updates CIRB Team Members: Sue Roll, CIRB Liaison
Keeley Hendrix CIRB Coordinator
Jo Ann Behrle CIRB HPA

16. Roundtable Discussion
Today’s Roundtable Discussion:
A look back over the past 5 years of StrokeNet and looking into the future.
 Today’s Hosts:
Scott Janis, PhD
Program Director
Division of Clinical Research
National Institute of Neurological Disorders & Stroke
Joseph P. Broderick, M.D.
PI NCC StrokeNet
Director – University of Cincinnati Neuroscience Institute

17. NINDS view from 30k feet July 25, 2018 Scott Janis NINDS
What StrokeNet is
Overview of structure and activities
Efforts with recovery and rehab

18. Public Health Burden of Stroke
Stroke is the Fifth Leading Cause of Death in the U.S.
6.8 million Americans have had a known stroke; almost 800,000 new strokes each year (~23% are recurrent strokes).
The aging of the US population is on course to lead to a 21.9% increase in prevalence of stroke by 2030.
Hypertension and atherosclerosis are the most common treatable risk factors for stroke, cognitive decline and dementia.
“Silent strokes” can be seen in 6% - 28% of older people, and are associated with cognitive decline and dementia.
White matter disease can be seen in 40-80% of older people, and are associated with hypertension and risk of cognitive decline and dementia.
Nearly half of people ≥65 years old have cognitive deficits 6 months after an ischemic stroke

19. NIH Investment in Stroke Research
NINDS -
stroke and cerebrovascular biology
Overall NIH invested $288M in Stroke research FY 2015

20. Acute Treatment Recovery Prevention Reperfusion Hemostasis Genetics
Athero research
Genetics
Epidemiology
Behavior change
Cerebrovascular biology
Recovery
Neuroplasticity
Biology of Repair post-Injury
Neural Regeneration
Acute Treatment
Hemostasis
Neuroprotection
Reperfusion

21. Clinical Studies of Highly Promising Treatments
Prevention
Prevention of Vascular Cognitive Impairment (VCI)
Imaging Biomarkers in Stroke Prevention: From Bench to Bedside
Expediting High Priority Comparative Effectiveness Research (CER) Trials in Stroke Prevention
Treatment
Preclinical and Clinical Studies to Improve Early Reperfusion Therapy and Establish Limitations of Late Reperfusion Therapy
Preclinical and Clinical Studies to Achieve Robust Brain Protection
Expand and Integrate Existing Stroke Trial Networks to Accelerate Translation
Recovery
Translational Research Using Neural Interface Devices for Stroke and Other Neurologic Disorders
Program for Translational Research Targeting Early Recovery after Stroke in Humans
Theme across all 3 areas was need for infrastructure
Cross-cutting
Accelerate the Translation of Stroke Research in Preclinical Animal Models into
Clinical Studies of Highly Promising Treatments

22. $50k/year/hub for training Infrastructure Total Cost- ~$10million/year
Established in 2013
29 regional centers (24 funded) with 400 satellite stroke hospitals, a coordinating center, and a data coordinating center
Small and large clinical trials and research studies to advance acute stroke treatment, stroke prevention, and recovery and rehabilitation.
$50k/year/hub for training
Infrastructure Total Cost- ~$10million/year
Census Region:
West Midwest South Northeast
Stanford
UCLA/USC
UCSD
U Utah
U Minnesota
U Iowa
Northwestern U at Chicago
U Michigan
Case Western Reserve U
U Cincinnati
Emory
U Miami
U Texas Houston
Medical University
South Carolina
Medstar Health/NIH and
U Virginia
U Pittsburgh
U Pennsylvania
Massachusetts General Hospital
Columbia and Cornell
UW Medicine
U Wisconsin
Yale U and Brown U
NY City Collaborative RCC
UCSF
Ohio State
Washington U
Wake Forest U
Vanderbilt
U Alabama
Renewal RCC
NINDS created StrokeNet in 2013 to better support our clinical stroke program by maximizing our ability to prioritize, harmonize, and efficiently conduct clinical trials in stroke prevention, treatment, and recovery
The network is a direct response to the recommendations of the Stroke Progress Review Group and NINDS Stroke Planning efforts in 2012 that identified a need and the opportunity to establish a stroke trial network infrastructure
The network is designed to support early exploratory phase 2 to confirmatory phase 3 clinical trials
Committed cost of Infrastructure each year including indirect’s is $ 10M. The StrokeNet replaced the previous costs of the SPOTRIAS program which cost the NINDs approximately the same $13M a year in total cost to support 7 extramural academic Stroke Centers.
New RCC
Legacy RCC
Coordinating Center & RCC

23. The Stroke Network Vision:
Increased trial efficiency
Balanced, prioritized set of early phase and phase 3 trials in prevention, treatment and recovery
Provides an efficient path for phase 2 moving to phase 3
Allows the logical ordering of trials that enter into network and create a pipeline of future trials for the network
Stable infrastructure and research capacity
Improved team research among different subspecialties
Stable funding for research effort, fellowship training
Improved data sharing
Single data center with uniform governance for data access
Fosters the use of CDEs
Coordination and public-private partnerships with non-profits, industry, and international partners
Manages trials that compete for the same patient groups
Established upon the commitment to consider ALL eligible stroke patients for a trial
Trains the next generation of Stroke clinical researchers

24. Teamwork is the Solution
Stroke Coordinators
New Investigators
Translational Stroke Science
Informatics
NeuroSurgery
Statisticians
Stroke recovery
Vascular Neurology
Neurointerventional
Neuropathology
Emergency care
Non-profit Stroke Associations
Industry
Epidemiology
Health Technology
Neuroimaging
International partners
FDA
PCORI/AHRQ
Pediatrics
Patient
Prevention
Treatment
Recovery

25. Goals of the Network
To be the leading platform for stroke trials in the U.S. and globally
To reduce the burden of stroke in the U.S and globally

26. Recently Approved Trials
Current Trials
Domain PI
SLEEP-SMART
Sleep for Stroke Management and Recovery Trial
Prevention/Recovery
Devin Brown
(Contact PI)
Ronald Chervin
MOST
Multi-Arm Optimization of Stroke Thrombolysis Stroke Trial
Acute
Ope Adeoye
Andrew Barreto
Jim Grotta
Joe Broderick
TRANSPORT 2
Transcranial direct current stimulation for Post-stroke motor Recovery - a phase II study
Recovery
Wayne Feng
(Contact PI)
Gottfried Schlaug
SATURN
Statins use in intracerebral hemorrhage patients
Prevention
Magdy Selim
(Contact PI)

27. (ancillary to CREST2 trial) Prevention (Ancillary)
Ancillary Studies
Study
Domain PI
CREST H
CAROTID REVASCULARIZATION AND MEDICAL MANAGEMENT FOR ASYMPTOMATIC CAROTID STENOSIS TRIAL – Hemodynamics
(ancillary to CREST2 trial)
Prevention (Ancillary)
R. Marshall, MD

28. Year ahead Renewals – new awards in Aug Bring in new centers
World Stroke Congress – StrokeNet/GAINS invited session
Recovery Workshop in the Fall
New trials in the pipeline
Lot’s of work ahead!!!

29. What We Need from Study Coordinators
Help to build teams within RCC and internally within RCC headquarters
Recruitment – best practices, what is helping, what are the barriers – share with other coordinators and with PIs.
Problem solve administrative delays at your sites.
Do tasks in parallel, not serially (example trial documents for investigators while working through IRB).
Build relationships within your institution of people who do the other jobs (e.g. contracts, cIRB).
Make use of your PI

30. Joseph P Broderick, MD Principal Investigator National Coordinating Center

31. Performance Metrics WebDCU Dashboard Numbers
Enrollment - Number of subjects enrolled
Retention - Percent of participants not retained
Regulatory Document Collection - Percent of outstanding documents
Case Report Collection- percent of outstanding documents
CIRB Submission - Time from receiving the CIRB packet to submission is less than 90 days
CTA Execution - Time from receiving the CTA to execution is less than 45 days

32. Performance Metrics
Data Reported on the Quarterly Activity Report (QAR)
Number of QARs submitted on time
Self-reported but confirmed by NCC, participation in network activities such as working groups, relevant StrokeNet calls, and in-person meetings
Self-reported but confirmed by NCC, participation in StrokeNet educational activities including faculty/trainees/staff presentations, and outreach to SS/PS

33. Goals of Next Five Years
6-8 ongoing Phase II and Phase III trials. Would like a few smaller trials if possible since large definitive trials require a lot more resources.
Should provide more work at RCCs/sites.
Continued grow infrastructure to address these trials ( 3 trials with 100+ sites and 4 if include CREST). Budgets for newer trials will have more infrastructure costs.
Continued success with clinical research and educational program for stroke fellows and educational presentations for fellows, coordinators, and faculty.

34. How StrokeNet will be Judged Overall
Trials funded and completed
How many trials submitted and funded?
Did we meet planned targeted recruitment and time to recruit?
Did the trial change or confirm practice? How impactful?
Did we address all three areas – prevention, recovery and acute stroke?
Did the financial investment for completed trials compare well to financial investment in period prior to StrokeNet? If you assume first two years is start-up, what is the return on investment?
Comparison of costs of stroke trials by NIH as compared to industry – that is probable best measure of return on investment (example POINT vs. SOCRATES).
Educational programs and graduated fellows

35. General Information and Reminders
Agenda items for Montreal Meeting.
Presenters for upcoming Meetings/Coordinators Calls.
SPLASH due August 1
Confirmed Montreal Managers Breakout Session
Meet and Greet the evening before the meeting (time and place TBD).
RPPR reports due
Review sites FWA for expiration dates and name changes.
MTA and RA amendments coming soon.