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

Monthly Webinar Series

March 2020

Today’s Agenda

Announcements & Trial Updates/Reminders Shannon Hillery Highlights from the TREAT-MS SAC Meeting Scott Newsome & Ellen Mowry Monthly Randomization Race Shannon Hillery Single Scull Regatta Standings Shannon Hillery Q&A All

Announcements

SHANNON HILLERY

VISION EDC

• Only access the TREAT-MS EDC using this URL:
• treat.preludedynamics.com
• Do not use this URL:
• etm.preludedyanmics.com
• Previously used for start-up purposes (GEMS)
• Will no longer be available for use in near future

VISION EDC

Your log in page should not look like this. This is using the incorrect URL: etm.preludedynamics.com Site coordinators attempting to log in here will see this notification, linking them to the TREAT-MS EDC at treat.preludedynamics.com

VISION EDC

If patients are having trouble remembering their log-in credentials, check this box VISION will send an email to the patient containing their username and password This email contains a reminder that usernames and passwords are case sensitive- remind your patients when their log in information is set up at baseline!

Trial Updates

• As of March 2nd, 2020, we have 468 patients enrolled. We have surpassed the

half way point!!!

• The central IRB met again this week for our continuing review and it was
• approved. The approval letter was emailed to site PIs and coordinators on

Tuesday, 3/3. Please make sure your regulatory contact receives it and submits it to the local IRB this week!

• Thank you all for your commitment and dedication to our trial!!!

TREAT-MS Trial Updates

Let’s celebrate our top 10 enrolling “STAR” sites (not including JHU)!

Swedish Medical Center 28 University of Alabama at Birmingham 24 Christiana Care Health Services 23 Norton Neurology Services 21 Baylor Scott & White Health 20 Geisinger Clinic 17 University of South Florida Health 17 University of Florida 16 University of Kansas Medical Center 16 THANK YOU for leading the way! Barrow Neurological Institute 14

Keep doing what you do well!

TREAT-MS Trial Updates

Let’s encourage our next 12 enrolling sites (Rising STARS)!

University of California, San Diego 13 New York University 12 University of Utah 12

YOU

University of California, Los Angeles 12 Advanced Neurology Specialists 12

CAN

Mayo Clinic 11 Cedars-Sinai Medical Center 10

DO

Dignity Health Sacramento 10 Allegheny Health Network 9

IT!!!

Columbia University Medical Center 8 University of Miami 8 University of Washington 8

Highlights from the SAC In-Person Meeting #3 held on February 26, 2020

ELLEN M. MOWRY, M.D., M.C.R. ASSOCIATE PROFESSOR OF NEUROLOGY AND EPIDEMIOLOGY JOHNS HOPKINS UNIVERSITY SCOTT D. NEWSOME, D.O. ASSOCIATE PROFESSOR OF NEUROLOGY JOHNS HOPKINS UNIVERSITY

SAC AC M Mai ain n Top

• pics

ics

Recruitment – Today’s Webinar Topic Protocol Adherence – April’s Webinar Topic Study Retention & Treatment Adherence – April’s Webinar Topic

Recruitment

SCOTT NEWSOME AND ELLEN MOWRY

100 200 300 400 500 600 700 800 900 1000

TREAT-MS Trial Enrollment - Target vs. Actual

Target - Cumulative RCT Total RCT Enrolled (Cumulative)

Overview/Reminder of Rationale for TREAT-MS MS

• There is

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• Whe

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• Th

Ther ere may be be sub subgroups of

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ld be benefit it mor

• re

e tha than ot

• the

hers

• Some observ

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• On th

the oth

• ther han

and, natu tural l his istory stu tudie ies sh showin ing decli line in in lon long-term MS S dis isab abili lity in inclu clude patie ients lar largely ly tr treated (e (especia iall lly ear arly in in th the course) with ith IN INJECTABLE medications

Recruitment: Have a plan

Not a seat-of-the-pants approach Listen to what the high enrollers do and develop a plan

Site Expectations/Goals

Designated Screens per week Designated Enrollments per week Have a Recruitment Plan

Not at Goal? What is/are your problem area(s)?

• Our site is not seeing enough newly-/recently-diagnosed patients
• Our site has a long wait-list and patients have already started therapy by the time they get an

appointment

• I personally do not see [m/any] new patients; my colleagues do, but are not referring to the trial
• I have not had the time to focus on enrollment
• Staff turnover
• Patients themselves do not seem interested
• Other

Potential Barrier: Waiting To Start (NEW SITES)

Slow start-up, still waiting for internal logistics, study team, etc.

• Start chart screening now
• Look ahead to ID newly-diagnosed

patients scheduled several months out to try to bring them in sooner/when you think trial may be able to launch

• Meet regularly with team to strategize

how you will catch up, continue to build enthusiasm from referring colleague

• PI should clear some time in schedule

to book TREAT-MS patients so can hit ground running

• Re-familiarize yourself with protocol,

forms, Vision database

• Don’t let perfect get in the way of

good

Potential Barriers: NOT MANY NEWLY DIAGNOSED PATIENTS BEING SEEN

• Reach out to referring providers,

guaranteeing fast access for newly- diagnosed appointments (can apply for a really strong referring provider for consideration of named authorship)

• Grand Rounds, neurology residents
• Ensure schedulers aware of goal to

prioritize scheduling newly diagnosed patients with site PI

• Mention TREAT-MS in local talks,

discuss with patients who may be local “leaders” in MS community

• Work with local NMSS chapters

Potential Barrier: Site PI Availability

Site PI doesn’t see any/all new referrals/newly-diagnosed patients

• Site PI will need to set up some

“non-traditional” clinic hours to

• pen to new patient
• Engage colleague at center who IS

seeing new patients (remember, s/he may have opportunity for listed authorship)

Potential Barrier: Patients Already on DMT at First Visit Due to Long Waitlist

• Prescreen patients before clinics
• Look far ahead to patients booked out (up to 6 months) to see

if you can ID those who look to be treatment-naïve RRMS and

• ffer earlier appointments
• Protect time for fast intake of newly diagnosed patients

Potential Barrier: Colleagues Reluctant to Randomize?

Re-educate them on the equipoise (we have many slides if you want to borrow a set)

• Observational data are confounded, particularly by indication for therapy
• Nonetheless, natural history studies DO demonstrate overall lower rates of

longer-term disability; most patients on SELF-injected meds

• Randomized controlled trials (RCTs) demonstrated margin of “benefit” of

stronger therapies included non-representative patients (healthier) and either included those who had FAILED first-line therapy, or left patients on the first- line therapy even when breakthrough disease occurred. Remind them that treatment switches for breakthrough disease are ENCOURAGED

Patients Not Interested? Refine Your Pitch!

Key points:

• There is EQUIPOISE in the trial (otherwise we would not be doing it!!)
• A lot of decisions are left up to the clinician/patient (autonomy)
• Visits and MRI schedule essentially identical to usual care (participants paid for

“extras”)

• A little extra time goes a long way
• Very low threshold for switching treatment (allowed if ANY disease activity occurs

after 6 months on therapy)

• Re-randomization at that point ONLY if the person was low-risk for disability at

enrollment AND was initially on first-line therapy (similar choice as outside a trial!)

“No Time” to enroll during a single visit: change your visit logistics

• Create an automatic 2 to 4-week follow-up appointment for patients

when they are scheduling a new patient appointment as a possible MS diagnosis (cancel if not needed)

• Presume that it will be on second (or third) visit that patients will be

ready to hear seriously about DMTs and possible participation

• Have all members of team (e.g. EDSS, MSFC) on call at second visit

to see patient if consents* *there is flexibility in breaking up the assessments if needed, but not by months. Please try to think about how actions will impact interpretability of the data.

Weekly Enrollment Trackers

• Graphical representations of the # enrolled versus the # PLEDGED TO ENROLL
• Have been modified to meet our new target enrollment completion of 6/2020

Example of site on track:

5 10 15 20 25

TREAT-MS Trial UAB

Enrollment Commitment Current Enrollment

Example of sites that need to ramp up:

5 10 15 20 25

TREAT-MS Trial Site B

Enrollment Commitment Current Enrollment 5 10 15 20 25 July-18 August-18 September-18 October-18 November-18 December-18 January-19 February-19 March-19 April-19 May-19 June-19 July-19 August-19 September-19 October-19 November-19 December-19 January-20 February-20 March-20 April-20 May-20 June-20

TREAT-MS Trial Site A

Enrollment Commitment Current Enrollment

REMEMBER…. THERE ARE PLENTY OF SITES THAT HAVE REACHED AND ARE NOW PURSUING HIGHER TARGETS. THESE GOALS ARE READILY ACCOMPLISHABLE. YOU MADE THE PLEDGE TO DO IT…. SO PLEASE COMMIT TO FIGURING OUT YOUR BLOCKAGES AND MOVING PAST THEM! REACH OUT TO THE SITE PIs OR TO OTHERS WHO ARE SUCCEEDING TO GET TIPS!

Breakout session #1 Tasks: Recruitment

• Briefly discuss with group what most successful strategies have been for you, other sites
• Reflect on what you perceive to be your biggest challenges to recruitment at your OWN

site

• Determine how many more patients between you and target recruitment
• Develop an “action plan” with 3 or more specific steps YOU will take to meet your

target, with a time frame

Breakout session #1 Tasks: Recruitment

• Successful Strategies Identified
• Study coordinator pre-screens charts and notifies providers ahead of

initial appointment about patient’s potential eligibility for the trial.

• Pre-screen charts > 1 month ahead of time to potentially expedite

appointments – scan all MS clinics through June 30, 2020 or beyond

• Re-initiate filtering of newly diagnosed, treatment naïve patients to site

PI to be evaluated sooner

• Identify a few new patients with > 30-45 day wait and consider an ad hoc

clinic / new patient clinic to see them sooner

Breakout session #1 Tasks: Recruitment

• Successful Strategies Identified (continued)
• Discuss trial periodically with colleagues (monthly staff meetings and

weekly email reminders)

• Improve referral pattern to trial through communication with residents
• n in-patient services: provide talk to residents
• Reach out to neuro-ophthalmologists who refer patients with optic

neuritis as well as emergency department and general neurology colleagues

• Site PI consents the patient if possible

Breakout session #1 Tasks: Recruitment

• Successful Strategies Identified (continued)
• Emphasize uncertainty in field upfront with potential candidate
• Emphasize importance of study and make sure patient understands the

study well

• Think about having patient pick DMT from each treatment class in initial

conversation before the study conversation

• Talk to colleagues about fast-onset / efficacy of fingolimod (traditional /

first-line treatment class)

Breakout session #1 Tasks: Recruitment

• Biggest Challenges to Recruitment at Sites
• Staff turnover (fellows, physicians, PAs and coordinators)
• Long waitlist and patients already started on DMT prior to being seen at

site

• Patients have strong preference for a particular DMT when they arrive
• Not enough new referrals
• Some patients are reluctant to start any DMT
• Competing trial
• Patients wanting to pursue pregnancy

Breakout session #1 Tasks: Recruitment

• Elements of Action Plans to Meet Target Recruitment
• Request IRB approval for additional local

recruitment efforts such as EPIC blast to potential patients; local NMSS sending email blast

• Request Spanish consent form
• Overcome staffing issues by over-booking newly

diagnosed patients

• Advertise on site’s website / utilize patient brochure

and make it available at patient check-in

• Extra time with patients in clinic
• See patients on non-clinic days
• Move new potential eligible patients up
• Hire/train new staff
• Ask admitting/scheduling group to put

notes on the appointment/chart that indicates new MS diagnosis (untreated) so coordinators pre-screening charts can find these potential candidates

• Ask admitting/scheduling group to email

site PI/treating clinicians when scheduling people with new MS diagnosis

Monthly Randomization Race

SHANNON HILLERY

Monthly Randomization Race

February’s Top Performers: Site # of Randomizations

Baylor Research Institute 6 Cedars Sinai Medical Center 3 Swedish Health Services 3 University of South Florida 3

• St. Joseph's Hospital and Medical Center Dignity Health

2

February’s Top Enroller:

Baylor Research Institute!

$50

Single Scull Regatta

SHANNON HILLERY

Single Scull Regatta Standings

Open for Questions

Thank You for attending today’s webinar!

Encore performance on Thursday, March 5th at 9 AM EST The April Monthly Webinar will be held on the 1st at 3 PM and 2nd at 9 AM EDT