1 / 26

DIAS 4 US Clinical Coordinating Center Overview

DIAS 4 US Clinical Coordinating Center Overview. Philip B. Gorelick, MD MPH FACP Director, US DIAS Clinical Coordinating Center (prepared for US DIAS Investigator Mtg, July 15-16, 2011, Chicago, Ill 30 minutes). Welcome to Chicago US DIAS 4 Investigators We look forward to a

giona
Download Presentation

DIAS 4 US Clinical Coordinating Center Overview

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. DIAS 4US Clinical Coordinating CenterOverview Philip B. Gorelick, MD MPH FACP Director, US DIAS Clinical Coordinating Center (prepared for US DIAS Investigator Mtg, July 15-16, 2011, Chicago, Ill 30 minutes)

  2. Welcome to Chicago US DIAS 4 Investigators We look forward to a productive collaboration!

  3. Introduction of UIC Staff US DIAS 4 Trial Clinical Coordinating Center

  4. Philip B. Gorelick, MD MPH John S Garvin Professor and Head Director, US DIAS Clinical Coord. Cntr Prior Federally Funded Grants: -PI of AAASPS (NINDS) -PI of Risk Markers for Dementia after Stroke (NIA) -PI of Studies of Dementia in the Black Aged (NIA) • Teaching Awards • AOA • Golden Apple • Langendorf • Other Awards • AHA Feinberg • NSA Visionary • Women’s Home • Journal: Top Stroke • Neurologist • 4. Mayo Clinic • Gainey Prof. • 5. Henry Barnett • Prof. Canadian • Stroke Network • 6. Stopplemoor • Lecturer, Univ of • Iowa Consultancies -Korean CDC -CMS MEDCAC -Alaskan Native Stroke Registry -AHA/ASA -WFN (applied research) -Goddess Fund for Stroke in Women -NSA

  5. UIC Dept. of Neurology Stroke Networking Experience Co-PI US DIAS Clinical Coordinating Center Director, Neuroepidemiology, Clinical Trials, & Outcomes Research Unit Consultancies -Korean CDC -National Stroke Association (NSA) -Lundbeck, Inc • Federally Funded • Grants: • TTP Surveillance • (NIH) • Recent Networking • Efforts: • 2. Paul Coverdell • National Stroke • Registry (CDC) and • Great Lakes Stroke • Network • Medicare Part D • Data Base & DRG • 559 Project Dilip K. Pandey, MD PhD

  6. Other UIC CCC Team Members • 1. Rebecca Grysiewicz, DO:Local Site PI, junior faculty member, past Chief Resident & Stroke Fellow, interests in acute stroke treatment & prevention • 2. Maureen Hillmann, RN:Nurse Manager, >15 years of experience as a stroke study nurse • 3. Yvonne Harris, MPA:Administrator, >23 years experience as stroke study project manager & administrator; Asst to Head at UIC • 4. Vidas Simkus:IT Support, >10 yrs experience in internet support services; programmer, trouble shooter, and builds servers

  7. Unique Features of the Current DIAS Trials • Desmoteplase Theoretical properties making it a unique agent for thrombolysis • Study Design 1. Answers an important question 2. Does so in a practical way (CT/CTA or MRI/MRA) 3. Potentially cost effective and practicable application of a thrombolytic in many hospital settings

  8. Clinical Coordinating Center (CCC) Model

  9. Background & Concept for Model Prior Experience AAASPS Recruitment Challenge

  10. African-American Antiplatelet Stroke Prevention Study (AAASPS) Networking experience with over 60 sites across US Source: JAMA, June 11, 2003-vol 289:2947-2957

  11. What We Learned About Networking from AAASPS • 1. Expect the unexpected • 2. Be nimble and be prepared to change recruitment strategies depending on the trial circumstances & if opportunity presents itself

  12. Dr. Pandey’s Networking Experience • 1. CAPTURE STROKE, Illinois CDC-Illinois Department of Public Health-funded Coverdell Stroke Registry Project of >60 hospitals in Illinois • 2. Great Lakes Stroke Network Quality improvement project for all hospitals in Great Lakes/Midwest region

  13. Concept for RecruitmentA Hub-Spoke Model

  14. US DIAS Recruitment ModelHub and Spoke System by 6 Regions 6 US Regions NE West MW MA SW SE MA=Mid-Atlantic SE=Southeast MW=Midwest SW=Southwest NE=Northeast Slide courtesy of David Hess, MD

  15. Hub DirectorsNationally Recognized US Stroke Experts • Midwest: Phil Gorelick/Dilip K. Pandey (UIC) • Northeast: Lee Schwamm (Harvard) • West: Greg Albers (Stanford) • Southwest: Tim Ingall (Mayo Clinic) • Southeast: David Hess (GHS) • Mid-Atlantic: Max Hammer (U of Pitt) Hub Directors with well-developed networks for stroke treatment

  16. Advantages of Model • Hub Directors 1. Know their regions & capabilities of local hospitals/PIs/Coordinators 2. Have trained stroke physicians in the area 3. Have telemedicine capability and ready-made networks to step into 4. Are experienced and well respected • Local Spoke Sites 1. Have the option to treat at site, ‘drip & ship’, or transfer to hub for treatment

  17. Strategies for US Local Site Selection • 1. Large systems of care in which interventionalists agree to randomize to DIAS study • 2. Mid-sized systems of care without interventionalists or ones who agree to randomize to DIAS • 3. Smaller systems of care as part of a network of treatment under a major hub study hospital

  18. Clinical Coordinating Center Goals Summary

  19. Clinical Coordinating Center Goals 1. Recruit 6 regional Hub Directors 2. Hub Directors/CCC/Lundbeck collaborate to recruit 15-20 local sites per regional hub 3. Work closely with Local Sites, Hub Directors & Lundbeck to recruit patients and successfully conduct US DIAS 4 4. Support Local Sites in recruitment efforts

  20. Current Status of Local Site Recruitment • 1. # of active sites:39 • 2. # of sites in process of being activated: 40 • Total #:79 • Site Locations by Hub 1. Midwest 28 4. West 9 2. Southeast 17 5. Mid-Atlantic 6 3. Northeast 14 6. Southwest 3* *An additional 4-5 sites pending in Southwest Hub; as of June 30, 2011

  21. Clinical Coordinating Center Activities to Stimulate Recruitment

  22. CCC Activities to Stimulate Recruitment • 1. Develop hub-spoke model & help recruit local sites • 2. Monthly webinars or teleconferences (DIAS MRI/A & CT/CTA inclusion criteria, importance of DIAS in light of thrombolytic and device therapies) • 3. Email announcements to coordinators & local principal investigators • 4. Assist in newsletter development • 5. Coordinate regional hub face-to-face & teleconference meetings moderated by Hub Directors

  23. What We Ask For in Relation to Recruitment… • 1. Your Commitment & Readiness • 2. Your Enthusiasm • 3. Your Vigilance • 4. Your Patience

  24. What We Are Striving For… • 1. Timely and successful US DIAS RECRUITMENT & STUDY CONDUCT • 2. Establishment of the US as the world leader in the DIAS trials • 3. The personal satisfaction of working on an important trial that will potentially lead to an important new treatment option for stroke patients in the US and worldwide

  25. Q and AHow Can We Help You to Be Successful? Alaskan Sea Otter says: “Enroll in US DIAS 4!” Enrollment to Date:17* Target Enrollment: 200 (*as of July 11 2011) Seldovia, Alaska - 2005 Photo courtesy of H. Powell

  26. Questions/Answers& Transition into the compelling story of DIAS recruitment success Dr. Thomas Devlin & Dr. George Lopez

More Related