Mo Monthly Webinar Se Series July, 2018
To Today’s Agenda • Announcements and Trial Updates Amanda Bistran-Hall • Tips for Success: From the Perspective of the Study Coordinator Madiha Qutab • Tips for Success: From the Perspective of a Treating Physician Scott Newsome • Tips for Success: From the Imaging Analysis Center Blake Dewey • Mt. Everest Christina Grabarits • Q & A Team
An Announcem cemen ents
Route to Webinars http://treat-mstrial.org
If If You ou Watch a Web ebinar Rec ecor ording Pl Please Fi Fill Out ut Thi his Webi binar nar Repo port
TR TREAT-MS MS Trial Updates Enrollment update First site activated 4/2018- Johns Hopkins University First patient brought in for screening 4/2018 Enrolled: 8 In screening: 3 Reasons for non-participation: pregnancy, randomization, study too demanding/wary of research
TR TREAT-MS MS Trial Updates (continued) First 4 new sites IRB-approved on 06/21/18! ◦ Advanced Neurology Specialists – PI: Dr. Dennis Dietrich, Lead Coordinator: Laura Armstrong ◦ Christiana Care Health Services – PI: Dr. Jason Silversteen, Lead Coordinator: Kathleen Greenbaum ◦ University of Rochester – PI: Dr. Andrew Goodman, Lead Coordinator: Paul DeRitis ◦ University of Vermont – PI: Dr. Andrew Solomon, Lead Coordinator: Jane Low Submitted 5 more sites for IRB approval on 06/27/18 ◦ New York University School of Medicine ◦ Swedish Health Services ◦ The University of Texas Southwestern Medical Center ◦ University of Cincinnati ◦ University of Florida
Ne Next Steps for Sites Ø Getting subcontracts partially executed by study sites so they can be fully executed after IRB approval. Ø Completing training and submitting remaining regulatory documents to EDC. Ø Site Activation!
Ne Newly Activated Sites!!! Christiana Care Health Services on 07/05/18. Advanced Neurology Specialists on 07/09/18. Welcome aboard!!!
TR TRad aditional al vs. Ear arly y Aggressive Th Therap apy y for Mu Multiple Sclerosis (TREAT-MS MS) Trial: Tips for Success EL ELLEN EN M. MOWRY (CO-PI PI; TRE REATING SC SCOTT D. NEWSO SOME (C (CO-PI PI; TR TREATI TING PHYSICIAN) PHYSICIAN) PH MADIHA QUTA MA TAB (P (PROJECT MANAGER BL BLAKE DE DEWEY (I (IMAGING ANALYSIS CENTER) AND STUDY COORDINATOR) AN
Objectives • To review the logistics and address FAQ about TREAT-MS Trial • From the perspective of the study coordinator (Madiha) • From the perspective of a treating physician (Ellen/Scott) • From the Imaging Analysis Center (Blake)
Prep for TREAT-MS Screening/Baseline study visit Access CRFs on TREAT-MS website Add new patient in Vision database Schedule blinded EDSS and blinded MSFC examiners During Visit Provider discusses elements of study with patient Labs pending/labs reviewed and narrowed down treatment options Patient consented/Patient took consent home to review (defer “baseline”)
During Visit • Follow the baseline study visit checklist • When consented, ask patient questions on Documentation of Consent form • Treating Provider goes though I/E criteria and Risk Stratification with the patient before randomization; with lab results available, provider could narrow down the treatment options with the patient
During visit: Blinded examiners administer MSFC and EDSS Baseline Brain MRI Upload zipped DICOM on the MRI upload page OCT (if standard of care) Complete OCT CRF and upload OCT PDF in Source Docs
ePROs At the study visit, have patient create their vision login to access ePROs; Patient will login to vision and complete PDDS and Social Status ePROs at the visit Challenges: Patient may forget to complete ePROs at home; patient is notified via email to complete ePROs 2 weeks after randomization date/time ePROs not completed within ePRO window (within 45 days from baseline) Strongly encourage patient to complete all ePROs at their visit
After visit Follow-up with patient to confirm DMT start Once CRFs completed in vision, submit for review Once patient completes ePROs, submit for review Follow-up with patient if ePROs not completed in vision Medical/Surgical History, Concomitant medications, and MS DMT will be reviewed and updated at follow-up
Challenges: Multiple study visits on same day If needed, split baseline visit into two days Patients forget to complete ePROs Strongly encourage patient to complete all baseline ePROs at the visit If not completed, follow-up with patients; offer to fax or mail ePROs for patient to send back within study ePRO window (45 days since baseline)
Objectives • To review the logistics and address FAQ about TREAT-MS • From the perspective of the study coordinator (Madiha) • From the perspective of a treating physician (Ellen/Scott) • From the Imaging Analysis Center (Blake)
Ho How do I identify and enrich the pool of el eligible e candidates es for or TRE TREAT-MS MS? • Strategies may differ depending on type of clinic and referral workflow • At our tertiary MS clinic, a clinic RN screens new referrals; we have asked her to flag all newly-diagnosed patients and notify us • If the person may be a TREAT-MS candidate, Scott and/or Ellen makes an appointment available as an add-on • Alternatively, we direct the person to a visit with another provider if there is an opening in their schedule within the next few weeks • Recruitment materials available for all sites, with space for site- specific information to be pasted on a label • We are also working with the CMSC and the National MS Society to disseminate updates • Plans are for local email blasts by NMSS in stages, as sites open
If If I I identify a patient as eligible, how do I I di discus uss the he trial with h he her/hi him? • 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) • 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 a first-line therapy (similar consideration as outside of a trial!)
Pa Patient Logistics (Clinician Pe Perspective) • Due to need to complete diagnostics, check safety labs, or due to patient feeling overwhelmed, etc, it is often necessary for newly-diagnosed patients to have more than 1 visit to work through the implications of diagnosis, decide on treatment (even independent of TREAT-MS) • One of the perks of the “add-on” model is less rushed interaction than classic clinic appointment • We call the baseline visit the one in which the patient signs consent form
Pa Patient Logistics (Clinician Pe Perspective), continued: • At baseline visit, several possibilities of how to approach DMT discussion: • If safety labs already complete: can randomize and decide on DMT on the spot • If safety labs not done/pending: can still enroll. Randomize AFTER safety labs completed and resulted (although, as long as eligible for at least one early aggressive therapy can randomize- HIV negative and JCV negative) • Can narrow down therapies within each category (pending safety labs and randomization), or • Can bring in for another visit to randomize and/or decide on therapy within category, or • Can complete randomization and therapy discussion remotely (e.g. by telephone)
Visit Logistics (Clinician Perspective): • We have shareable EPIC note templates available that can be used to help quick data entry into CRFs • Useful to order the baseline MRI and OCT (if applicable) right at that visit, and to schedule the month 6 follow-up right at that time as well • We have medication appeal letters and checklist of disease characteristics that you can incorporate into clinic notes and/or insurance appeals • Since meds are all approved for MS, our PRA analysts said notification to insurance company that patient is in trial NOT required (Recommend NOT stating trial involvement in notes)
Visit Logistics (Clinician Perspective), continued: • We are working with manufacturers of higher-efficacy therapies to best understand access programs so as to avoid denials • Biogen already has a patient access program for natalizumab. • No response to date from Genzyme (alemtuzumab). • Genentech rolling out a pilot program that will help those who are denied ocrelizumab by insurance. • If patient’s household income $150,000: request “escalation” due to concern about patient safety with respect to delay of medication start à easy approval • Available for all patients, not just trial patients
Objectives • To review the logistics and address FAQ about TREAT-MS • From the perspective of the study coordinator (Madiha) • From the perspective of a treating physician (Ellen/Scott) • From the Imaging Analysis Center (Blake)
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