Monthly Webinar Series February 2020 Todays Agenda Announcements - - PowerPoint PPT Presentation

Monthly Webinar Series

February 2020

Today’s Agenda

Announcements & Trial Updates/Reminders Shannon Hillery The Single Scull Regatta Shannon Hillery and Ryan Majkowski Monthly Randomization Race Shannon Hillery Q&A All

Announcements & Trial Updates

SHANNON HILLERY

Study Updates

• As of February 4th, 2020, we have 442 patients enrolled. We are SO CLOSE to

the half way point!!!

• We have submitted materials to the central IRB for the continuing review.
• We had a DSMB meeting on January 31, 2020 and the DSMB voted to continue

the trial without modification.

• Thanks to everyone for keeping the VISION database up-to-date and getting

the continuing review documents back to us in a timely fashion.

Reminder – SAC Meeting in 3 Weeks!

Wednesday, February 26, 2020 – 1:30- 5:00 pm Hilton West Palm Beach, Florida

Looking forward to celebrating reaching our 50% enrollment milestone and strategizing to get to full enrollment!

Please reach out to Susan Emrich (semrich1@jhmi.edu) with any travel/lodging questions.

Th The Single Scull Regatta

SHANNON HILLERY

TIN Workgroup Informed Focus

Why Game?

• Gaming Work Group Mission Statement: Incorporate gaming innovations into clinical trial
• perations for networks to enhance site engagement, using competition and team

building to establish trust and rapport and ultimately improve performance.

• Friendly Competition
• Easy and Live method of assessing one’s own site performance
• Fun way to recognize top performers and highlight ways in which different sites excel

Fun Facts!

Rowing was first used as a means of transport in ancient Egypt, Greece and Rome A single sculler could reach a top speed of more than 13 miles per hour, almost as fast as the top speed of a boat with four rowers! Rowing is one of the

• riginal sports in the

modern Olympic Games Rowing was the first intercollegiate sport contested in the United States between Harvard and Yale in 1852

How do the games compare?

ROWING COMPETITION

• Rowboat teams by region
• 5-6 sites to one rowboat
• Sites entered the competition when they

became active to enrollment

• 1 year competition

SINGLE SCULL REGATTA

• Sites are in their own rowboats or “single

sculls”

• Sites start the competition simultaneously
• February 1, 2020
• 5 month competition (End: June 2020)

Point System

Metrics Points

Webinars 1.5 Screened 1 Randomized 4 % Data entered within 7 days of visit 10 % Queries within 2 weeks 10 Visits in-person completed 1 ePRO within 4 weeks (+/- 2 weeks), ePRO in-person between 6 weeks-3 months 0.5 0.25 Completion of all 3 Primary Outcome Assessments during in-person visits 2

Metrics

• Webinar Attendance
• Screened
• Randomized
• % Data entered within 2

weeks

• % 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

Webinars

• One person from each site must be in attendance
• 1.5 points are awarded per site (even if 3-4 members attend)

Example: 8 live webinars attended = 12 points

Webinars: Missed the Live Broadcast? Watching the recording:

• After the final broadcast (Thursdays. 9:00 AM EST) the webinar recordings and slides will be

posted to our website: treat-mstrial.org in the “Webinars” folder

• .25 points will be awarded to sites that were unable to make the live broadcasts if they watch

the recording within 5 days of the final broadcast

Screened Patients

• 1 point is awarded for each screened patient
• 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 4 screen fails =

30 points awarded

Randomized Patients

• 4 points are awarded for each randomized patient
• Randomization Goal: 1 new candidate per week

Example: 20 patients randomized = 80 points awarded

% Data Entered within 7 Days of Visit

• A maximum of

10 points can be earned per site

• Note: this is an overall

metric; not per patient

Points Overall Data Entry

10 100% entered within 7 days 9 ≥ 90-99.9% entered within 7 days 8 ≥ 80-89.9% entered within 7 days 7 ≥ 70-79.9% entered within 7 days 6 ≥ 60-69.9% entered within 7 days 5 ≥ 50-59.9% entered within 7 days 4 ≥ 40-49.9% entered within 7 days 3 ≥ 30-39.9% entered within 7 days 2 ≥ 20-29.9% entered within 7 days 1 ≥ 10-19.9% entered within 7 days < 10% entered within 7 days Example: 86% of all data was entered within 7 days of each visit = 8 points

% Queries answered within 2 weeks

• A maximum of 10 points

can be earned per site

• Note: this is an overall metric;

not per patient

Example: 56% of queries issues were answered within 2 weeks = 5 points

Points Overall Query Resolution

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

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

Example: 4 separate patients complete 5 of their in-person visits = 20 points are awarded

ePRO Completion

Calculation Points ePRO

Baseline completed within 45 days of randomization 0.5 Baseline only Any ePRO completed +/-6 weeks from expected date 0.5 Month 3 Month 9 Month 21 Month 33 Month 48 End of Treatment Any ePRO completed between 6 weeks - 3 months from expected date 0.25 Any ePRO not completed Any ePRO completed out of window

Example: 20 completed ePROs at baseline + 10 completed ePROs between 6 weeks-3 months for all patients = 12.5 points

3 Primary Outcomes Completion

• If all 3 of the Primary Outcomes Assessments are completed per visit, 2 points

are awarded

• If less than 3 primary outcome assessments are complete, 0 points are awarded

EDSS 25-Foot walk Test 9-Hole Peg Test

Example: 40 patient visits all primary outcome assessments were completed = 80 points awarded

Scoring System

RYAN MAJKOWSKI

What’s different about the Single Scull Regatta Scoring?

Competition will be balanced from 2/1/2020 onwards Points gained from subjects enrolled before 2/1/2020 will be balanced between sites with varying numbers of patients already in follow up Points used for balance are still dependent upon successful outcomes visits of those enrollments

What’s different about the Single Scull Regatta Scoring?

Outcomes visits for subjects enrolled after 2/1/2020 will be scored normally Sites with no enrollments pre-2/1/2020 will receive balance updates based upon other measures Bottom Line: No site will have an advantage based upon outcomes visits from pre-2/1/2020 enrollments

Where can I follow along?

Balance points will be entered manually every month by the DCC before the monthly webinars Additions will be visible on the site demographics tab in VISION and in a separate column on the Rowing Competition scoreboard

https://treat.preludedynamics.com

The team structures are still active in VISION!

https://treat.preludedynamics.com

Where can I find my site’s score?

Single Scull Regatta in TREAT-MS News

SHANNON HILLERY

Single Scull Regatta

JHU

In Monthly Bulletins

The Top 5 sites will be showcased in the Monthly Bulletin The monthly bulletins are sent out the third week of the month, so be sure to keep up with the standings on the bulletins, as well as the webinars!

Monthly Randomization Race

SHANNON HILLERY

Monthly Randomization Race

January’s Top Performers:

Site # of Randomizations Mayo Clinic 3 OhioHealth Research Institute 3 Swedish Health Services 3 University of South Florida 2 Dignity Health Medical Foundation 2 Johns Hopkins University 1

January’s Top Enroller:

Mayo Clinic

$50

Open for Questions

Thank You for attending today’s webinar!

The March Monthly Webinar will be held on the 4th at 3 PM and 5th at 9 AM EST