Mo Monthly y Webinar r Se Seri ries November, 2018
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
Announcements/Trial Updates CHRISTINA GRABARITS
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.
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!!!
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.
Activated Sites
Re Recent Enrollments
The Rowing Competition CHRISTINA GRABARITS
• 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 What is it? 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
As Assigne ned teams ms West Midwest South Northeast Team A Team B Team C Team D Team E Team F Team G Team H Advanced Neurology University of Mayo Clinic Baylor Scott & White University of Christiana Care New York University University of Specialists California at San Health Louisville School of Medicine Vermont Francisco Swedish Medical University of University of University of Kansas Norton Neurology Vanderbilt University Stony Brook Columbia Center Washington Cincinnati Medical Center Services Medical Center University Presbyterian Providence Health Dignity Health Ohio Health University of University of Florida, University of University of Geisinger Clinic Sacramento Michigan Gainesville Alabama at Rochester Birmingham Billings Clinic Barrow Neurological Oklahoma Medical Wayne State University of South Neurology Specialists Icahn School of Massachusetts Institute Research Foundation University Florida Health of Tidewater Medicine General Hospital University of Utah University of MDH Research LLC Rush University University of Miami University of Barnabas Multiple University of California Los Medical Center Maryland Sclerosis Comp. Care Massachusetts Angeles Center Worcester Cedars Sinai University of Multiple Sclerosis Georgetown Hackensack Allegheny Health California San Diego Center of Atlanta University University Medical Network Center Central Texas Holy Name MD Neurology Center Consultants
Me Metr tric ics Ongoing Variables In-person Visits ePROS Primary Outcome Assessments Visits completed ePRO completed within EDSS • • • Webinars • M6 time period 25-Foot Walk Test • • Screened • M12 Baseline 9-Hole Peg Test • • • Randomized • M18 M3 • • % Data entered within 7 • M24 M9 • • days M30 M21 • • % Queries answered • M36 M33 • • within 2 weeks M42 M45 • • M48 M48 • • EOT •
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
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
% 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
% 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
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
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
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
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 Team A Sum of Pts Total = 47.5 Site 1 70 -- Site 2 30 -- Site 3 40 -- Site 4 50 -- • Only activated sites can contribute points to the team total • The competition will restart each competition year
R owing Competition https://treat.preludedynamics.com
Rowin Rowing g Comp Competition etition Sta Standi ndings ngs West Team B UCSF U of Washington JHU West Team A Northeast Team G Advanced Swedish Neuro U of Rochester Stony Brook NYU Midwest Team C South Team E U Cinn Mayo Clinic U of South U of Louisville Norton UFL Gainesville Florida Health Site Points South Team F 1. Points 2. UAB Vanderbilt Christiana Care 3. Northeast Team H 4. 5. U Vermont Columbia Presby Midwest Team D 6. Baylor Scott & 7. KUMC White Health 8. 9. 10.
Strategies and Tips for Enrollment Success TIRI GYANG, VICTORIA HOPE, DENNIS DIETRICH
Does anybody have any other experiences that have worked for you?
The Mount Everest Climb CHRISTINA GRABARITS
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