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 2 nd , 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 16 THANK YOU for leading the way! University of Kansas Medical Center 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 YOU University of Utah 12 University of California, Los Angeles 12 CAN Advanced Neurology Specialists 12 Mayo Clinic 11 DO Cedars-Sinai Medical Center 10 Dignity Health Sacramento 10 IT!!! Allegheny Health Network 9 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. SCOTT D. NEWSOME, D.O. ASSOCIATE PROFESSOR OF ASSOCIATE PROFESSOR OF NEUROLOGY AND EPIDEMIOLOGY NEUROLOGY JOHNS HOPKINS UNIVERSITY JOHNS HOPKINS UNIVERSITY
SAC AC M Mai ain n Top opics 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
TREAT-MS Trial Enrollment - Target vs. Actual 1000 900 800 700 600 500 400 300 Target - Cumulative RCT 200 Total RCT Enrolled (Cumulative) 100 0
Overview/Reminder of Rationale for TREAT-MS MS • There is is a great unmet need to id identify fy th the most appropriate tr treatment str trategy for pe people wit ith MS, , espe pecially early in in th the dis disease course • Whe hether a more aggressive tr treatment str trategy early in in MS prevents lo longer- term dis isability is is not cle clear. . • Th Ther ere may be be sub subgroups of of pa patie ients who ho wou ould ld be benefit it mor ore e tha than ot othe hers • Some observ rvational stu tudies hi hint towards early aggressive th therapy min inimizing dis isability and conversion to secondary progressive MS vs. . tr traditional. • On th the oth other 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: Not a seat-of-the-pants approach Have a plan Listen to what the high enrollers do and develop a plan
Designated Screens per week Have a Designated Recruitment Enrollments Plan per week Site Expectations/Goals
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
-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 Slow start-up, still build enthusiasm from referring waiting for internal colleague Potential logistics, study team, -PI should clear some time in schedule etc. Barrier: to book TREAT-MS patients so can hit ground running Waiting To -Re-familiarize yourself with protocol, forms, Vision database Start (NEW - Don’t let perfect get in the way of good SITES)
-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) Potential -Grand Rounds, neurology residents Barriers: -Ensure schedulers aware of goal to NOT MANY prioritize scheduling newly diagnosed patients with site PI NEWLY DIAGNOSED -Mention TREAT-MS in local talks, discuss with patients who may be local PATIENTS “leaders” in MS community BEING SEEN -Work with local NMSS chapters
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 Potential open to new patient -Engage colleague at center who IS Barrier: Site seeing new patients (remember, s/he may have opportunity for listed PI Availability authorship)
Potential Barrier: Patients Already on DMT at First Visit Due to Long Waitlist o Prescreen patients before clinics o 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 offer earlier appointments o 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 o 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) o Presume that it will be on second (or third) visit that patients will be ready to hear seriously about DMTs and possible participation o 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 TREAT-MS Trial UAB Example of site on track: 25 20 15 10 5 0 Enrollment Commitment Current Enrollment
10 15 20 25 0 5 July-18 August-18 September-18 October-18 to ramp up: Example of sites that need November-18 December-18 January-19 Enrollment Commitment February-19 March-19 TREAT-MS Trial April-19 May-19 Site A June-19 July-19 August-19 Current Enrollment September-19 October-19 November-19 December-19 January-20 February-20 March-20 April-20 May-20 June-20 10 15 20 25 0 5 Enrollment Commitment TREAT-MS Trial Site B Current Enrollment
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