Mo Monthly y Webinar r Se Seri ries November, 2018 Todays - - PowerPoint PPT Presentation

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Mo Monthly y Webinar r Se Seri ries November, 2018 Todays - - PowerPoint PPT Presentation

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Mo Monthly y Webinar r Se Seri ries November, 2018 Todays Agenda Announcements/Trial Updates Christina Grabarits Rowing Competition in Depth Christina Grabarits Strategies and Tips for Enrollment Success Tiri Gyang,

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Mo Monthly y Webinar r Se Seri ries

November, 2018

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Today’s Agenda

  • Announcements/Trial Updates

Christina Grabarits

  • Rowing Competition in Depth

Christina Grabarits

  • Strategies and Tips for Enrollment Success

Tiri Gyang, Victoria Hope, Dennis Dietrich

  • Mt. Everest

Christina Grabarits

  • Q & A

Team

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Announcements/Trial Updates

CHRISTINA GRABARITS

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Biobanking Update

Protocol version 1.8 and Consent form version 1.2 that include the biobanking substudy have been approved by Johns Hopkins central IRB. Consent forms will be revised for all sites and if sites are participating in the biobanking substudy, patients will be able to opt in or out of the substudy. Johns Hopkins will provide the supplies for drawing blood and shipping. The majority of tubes collected will be shipped ambient the same day, without any processing. Sites will be asked to spin tubes for serum aliquots and freeze them locally, batch shipping these on dry ice at a later time. To date Johns Hopkins, Advanced Neurology Specialists, University of Alabama at Birmingham, Christiana Care and Swedish have enrolled patients in the substudy. A total of 9 sites have received revised consent forms and supplies in preparation for enrollment.

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Trial Updates

We now have 21 sites activated and 45 patients enrolled! Sites are being activated each week and new sites are being submitted for central IRB approval this week. The Johns Hopkins site is starting to complete month 6 visits while still actively enrolling new

  • patients. Eight additional sites have started enrolling!

We need each activated site to try to screen at least 1 patient each week so we can ramp up enrollment numbers! Thank you for your dedication to the trial and please reach out with questions! The Johns Hopkins Coordinating Center is here to support you!!!

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Save the Date!!!

Next in-person Study Advisory Committee (SAC) meeting will be held in Dallas, TX on February 27, 2019 from 1:30 – 5 pm, preceding the ACTRIMS meeting. Look for communication from Susan Emrich this week for more details.

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Activated Sites

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Re Recent Enrollments

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The Rowing Competition

CHRISTINA GRABARITS

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What is it?

  • The enrollment phase site competition that tracks

performance across regional teams made up of 6-9 individual sites

  • It is meant to provide incentive and friendly

competition in order to encourage screening and enrollment, completion of follow-ups, and timely data entry

  • Annual award ceremonies will recognize the

winning teams with prizes

  • Individual standings at the completion of the trial

will be used to determine authorship for trial results publication

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West Midwest South Northeast Team A Team B Team C Team D Team E Team F Team G Team H

Advanced Neurology Specialists University of California at San Francisco Mayo Clinic Baylor Scott & White Health University of Louisville Christiana Care New York University School of Medicine University of Vermont Swedish Medical Center University of Washington University of Cincinnati University of Kansas Medical Center Norton Neurology Services Vanderbilt University Medical Center Stony Brook University Columbia Presbyterian Providence Health Dignity Health Sacramento Ohio Health University of Michigan University of Florida, Gainesville University of Alabama at Birmingham University of Rochester Geisinger Clinic Billings Clinic Barrow Neurological Institute Oklahoma Medical Research Foundation Wayne State University University of South Florida Health Neurology Specialists

  • f Tidewater

Icahn School of Medicine Massachusetts General Hospital University of Utah University of California Los Angeles MDH Research LLC Rush University Medical Center University of Miami University of Maryland Barnabas Multiple Sclerosis Comp. Care Center University of Massachusetts Worcester Cedars Sinai University of California San Diego Multiple Sclerosis Center of Atlanta Georgetown University Hackensack University Medical Center Allegheny Health Network Central Texas Neurology Consultants Holy Name MD Center

As Assigne ned teams ms

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Me Metr tric ics

  • Webinars
  • Screened
  • Randomized
  • % Data entered within 7

days

  • % Queries answered

within 2 weeks

Ongoing Variables

  • Visits completed
  • M6
  • M12
  • M18
  • M24
  • M30
  • M36
  • M42
  • M48

In-person Visits

  • ePRO completed within

time period

  • Baseline
  • M3
  • M9
  • M21
  • M33
  • M45
  • M48
  • EOT

ePROS Primary Outcome Assessments

  • EDSS
  • 25-Foot Walk Test
  • 9-Hole Peg Test
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Webinars

  • 1 person from each site must be in attendance
  • 1 point is awarded for each webinar per site
  • If nobody can attend the webinar live, be sure to watch the recording on the

website and fill out the attestation below the recordings to receive points

  • Example: 8 webinars attended, 8 points
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Screened and Randomized Patients

  • 1 point is awarded for each screened patient per site
  • Every screen* counts!

*Patients entered into the EDC as a screen should be those who were approached face-to-face and given a consent form to consider the study

  • Example: 30 patients screened (26 randomized and 4 were screen fails), 30 points awarded
  • 4 points are awarded for each randomized patient per site
  • Example: 20 randomized patients, 80 points awarded
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% Data Entered within 7 Days of Visit

  • A maximum of 10 points total per site
  • Example: 86% data entered within 7 days, 8 points awarded

point = 10 if 100% entered within 7 days point = 9 if >= 90-99.9% entered within 7 days point = 8 if >= 80-89.9% entered within 7 days point = 7 if >= 70-79.9% entered within 7 days point = 6 if >= 60-69.9% entered within 7 days point = 5 if >= 50-59.9% entered within 7 days point = 4 if >= 40-49.9% entered within 7 days point = 3 if >= 30-39.9% entered within 7 days point = 2 if >= 20-29.9% entered within 7 days point = 1 if >= 10-19.9% entered within 7 days point = 0 if <10% entered within 7 days

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% Queries answered within 2 weeks

  • A maximum of 10 points total per site
  • Example: 56% of queries answered, 5 points awarded

point = 10 if = 100% queries answered within 2 weeks point = 9 if >= 90-99.9% queries answered within 2 weeks point = 8 if >= 80-89.9% queries answered within 2 weeks point = 7 if >= 70-79.9% queries answered within 2 weeks point = 6 if >= 60-69.9% queries answered within 2 weeks point = 5 if >= 50-59.9% queries answered within 2 weeks point = 4 if >= 40-49.9% queries answered within 2 weeks point = 3 if >= 30-39.9% queries answered within 2 weeks point = 2 if >= 20-29.9% queries answered within 2 weeks point = 1 if >= 10-19.9% queries answered within 2 weeks point = 0 if <10% queries answered within 2 weeks

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In-person Visits Completed

  • 1 point is awarded for each visit completed per patient
  • 0 points are awarded if visit is missed
  • Example: For one site, 4 separate patients complete 2 of their in-person visits, then 8 points are awarded

Month 6 Month 12 Month 18 Month 24 Month 30 Month 36 Month 42 Month 48

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ePRO Completion

  • Points = 0.5 if the ePRO is completed at baseline
  • Points = 0.5 if the ePRO is completed (+/- ) 6 weeks from the expected date per patient
  • Points = 0.25 if ePRO is completed (+/- ) 3.5 months from the expected date per patient
  • Point = 0 if the ePRO is not completed or missed
  • Example: For one site, there are 20 completed ePROs at baseline and 10 completed ePROs in (+/-) 3.5

months across all of their patients, 12.5 points awarded

Baseline Month 3 Month 9 Month 21 Month 33 Month 45 Month 48 End of Treatment

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All 3 Primary Outcomes Completed

  • 2 points are awarded if all 3 of the primary outcome assessments are

completed per visit per patient

  • 0 points are awarded if less than 3 primary outcome assessments are

completed per visit per patient

  • Example: 40 visits done where all primary outcome assessments were completed, 80 points awarded

EDSS 25-Foot walk Test 9-Hole Peg Test

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How will the points be calculated?

  • Each of the site’s points will be summed and an average of the team points will

be used for the total

  • Only activated sites can contribute points to the team total
  • The competition will restart each competition year

Team A Sum of Pts Total = 47.5 Site 1 70

  • Site 2

30

  • Site 3

40

  • Site 4

50

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R

  • wing Competition

https://treat.preludedynamics.com

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Northeast Team H U Vermont Columbia Presby South Team E U of Louisville Norton UFL Gainesville South Team F Points Vanderbilt UAB Christiana Care Midwest Team C U Cinn Mayo Clinic Northeast Team G U of Rochester Stony Brook NYU West Team A Swedish Advanced Neuro West Team B UCSF U of Washington

Rowin Rowing g Comp Competition etition Sta Standi ndings ngs

Site Points

1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

JHU Midwest Team D Baylor Scott & White Health KUMC U of South Florida Health

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Strategies and Tips for Enrollment Success

TIRI GYANG, VICTORIA HOPE, DENNIS DIETRICH

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Does anybody have any

  • ther experiences that have

worked for you?

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The Mount Everest Climb

CHRISTINA GRABARITS

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ELEVATION

Mount Everest Contenders

*Not fit to scale

92.4 87.3

  • 11. University of California at San Francisco

86.9

  • 2. Dignity Health Sacramento

40.5 45.0 104.9 63.0

  • 13. Columbia Presbyterian
  • 4. Massachusetts General Hospital
  • 5. Allegheny Health Network

39.3

  • 3. Advanced Neurology Specialists

83.3

  • 10. University of Miami
  • 7. Providence Health
  • 6. University of Maryland
  • 8. Georgetown University

35.3

  • 1. Central Texas Neurology Consultants
  • 8. Norton Neurology Specialists
  • 2. Christiana Care
  • 5. NYU School of Medicine
  • 10. University of Rochester

Activated Sites

  • 7. Swedish Medical Center
  • 4. University of Vermont
  • 9. University of Alabama at Birmingham
  • 6. University of Florida Gainesville
  • 12. University of Kansas Medical Center
  • 3. Cedars Sinai
  • 9. Neurology Specialists of Tidewater
  • 1. Johns Hopkins University
  • 14. Mayo Clinic
  • 15. University of South Florida Health
  • 16. Stony Brook University
  • 17. Vanderbilt University Medical Center
  • 18. University of Louisville
  • 19. Baylor Scott & White Health
  • 20. University of Cincinnati
  • 21. University of Washington
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Rank Activated Sites Final Points

1 Christiana Care 134.5 2 Norton Neurology Specialists 130.9 3 Baylor Scott & White Health 122.1 4 Columbia Presbyterian 112.6 5 University of Cincinnati 103.3 6 Advanced Neurology Specialists 85.3 7 New York University School of Medicine 85.2 8 University of Washington 65.7 9 University of Rochester 50.5 10 Vanderbilt University Medical Center 47.7

Mount Everest Standings

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  • Mt. Everest on GEMS
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Open for Questions

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Thank You for attending today’s webinar!

December’s Monthly Webinar will be held on the 5th at 3pm and 6th at 9am Eastern