Mon onthly W Webinar ar Ser Series April, 2018 Todays A - - PowerPoint PPT Presentation
Traditional vs. Early Aggressive Therapy for Multiple Sclerosis TREATMS Mon onthly W Webinar ar Ser Series April, 2018 Todays A Agenda Announcements Amanda Bistran-Hall News and Updates Amanda Bistran-Hall 90-day Start-Up
Traditional vs. Early Aggressive Therapy for Multiple Sclerosis TREATMS
April, 2018
Amanda Bistran-Hall
Amanda Bistran-Hall
Karen Lane
Team
Thursday at 9am Eastern of every month
Sites Represented:
Research
Center
O U R S I T E M A N AG E R S W I L L B E AWAY
Carolyn: Sarah: April 7 – 21 April 12-19 Back-up Managers: Noeleen Amanda Katie Tracey Your back-up Site Managers will be conducting your weekly meetings as scheduled.
To learn more about the TREAT-MS study, please visit: [insert website]
Resources
Please see the NMSS and CMSC websites for information on MS: https://www.nationalmssociety.org http://www.mscare.org/
Funded by:
Togetherwe arestronger
Join us in our fight to improve treatment for Multiple Sclerosispatients
Didyouknow?
There is an unmet need to evaluate initial therapeutic strategies and strategies for switching therapies during the relapsing-remitting phase of multiple sclerosis (MS). Currently there is a lack of evidence- based guidelines to help MS providers determine which treatment strategy is best for patients with MS. There are many treatments for MS, but in this study doctors are trying to understand which types of treatments are most appropriate to begin with. Medical care only improves with the help
can help improve the treatment and
[Insert POC name] [Insert POC number]
Why should Iparticipate?
Satisfaction that you may contribute to improved care for future MS patients Help improve decision-making for providers and greater community Help better understand how to treat people with MS
Whatmedicinewill I take?
Most treatments in the TREAT-MS study are FDA-approved for relapsing-remitting MS. If you participate, you will be randomly assigned (like a flip of a coin) to one of two standard types of therapy:
Whathappensat studyvisits?
A screening visit to see if the study is right for you Visit with your MS provider every 6 months for 4 years for medical check-ups and questionnaires Brain MRI at least yearly Brief online questionnaires collected between visits
HowdoIgetinvolved?
Please talk with your MS provider to see if TREAT-MS is a good fit for you. For more information, please e-mail TREATMS@jhmi.edu or visit [insert website]. [Insert POC name] [Insert POC number]
What isTREAT-MS?
TREAT-MS is a study where we hope to identify specific treatments that can prevent, delay, or lessen disabling effects of multiple sclerosis (MS) over time.
Who canparticipate?
You may be able to participate if you: Are 18-60 years of age Have relapsing-remitting MS (symptom flare-ups followed by periods with few to no symptoms) Have not been on chemotherapy in the past year Have never been treated with rituximab,
Have not been on any disease modifying therapy for MS for > 6 months duration Have not been on any MS treatment in the past 6 months Are HIV negative Traditional therapy, such as a shot or
Early aggressive therapy, such as an infusion With the advice and guidance of your MS provider, you will choose the specific therapy within the group you are assigned to that is the best fit for you. We value your participation, and you will be financially compensated for your time.
TRaditional versus Early Aggressive Therapy for Multiple Sclerosis (TREAT-MS) Trial
Protocol Number: IRB00143534 There is an unmet need to evaluate initial therapeutic strategies and strategies for switching therapies during the relapsing-remitting phase of multiple sclerosis (MS). Currently there is a lack of evidence- based guidelines to help clinicians determine which treatment strategy is best for patients with MS. Randomized controlled trial in people with relapsing-remitting Multiple Sclerosis (RRMS) N=900 Stratified by higher vs. lower risk for long term disability Randomized 1:1 to early aggressive vs. traditional disease-modifying therapy (DMT) class (specific therapy within assigned therapy class at the discretion of you and your patient)Inclusion Criteria
Aged 18-60 RRMS by 2017 McDonald criteria No chemo in last year HIV negative Must be EITHER JC virus antibody negative or low positive (index antibody titer <0.9), OR negative for: Hepatitis B and C, tuberculosisAbout the Study Exclusion Criteria
Use of any MS DMT in the past 6 months Prior use of rituximab, ocrelizumab, alemtuzumab, mitoxantrone or cladribine Prior use of any other MS DMT for > 6 months duration Use of other investigational drugs for MS UseStudy Activities
Study participation: 48+ months Evaluation includes: standardized neurologic exam/disability measures and other performance measures Standard-of-care brain MRIs at baseline, 6 months, 12 months and annually thereafter Routine Optical Coherence Tomography tests annually at select sites Clinic evaluation every 6 months Collect electronic patient reported outcomes Principal Investigators: Ellen M. Mowry, MD, MCR and Scott D. Newsome, DOContact Information
POC Name: [Insert] Email: [Insert] Phone: [Insert] Funded by: Protocol v1.6 & consent template approved by JHM IRB!
March 27
Protocol, consent form template and local context questionnaire (LCQ) to sites
April 5 (today!)
Completed LCQ due (2 weeks)
April 19
Karen Lane
Site FWA SMT IRB Exchange Portal LOI Subcontract Sent
Advanced Neurology Specialists
Y N N N
Yes
Baylor Scott & White Health (Dallas, TX)
Y Y N Y
Yes
Billings Clinic (Billings, MT)
Y N N N
Yes
Cedars Sinai Medical Center
Y Y Y Y
Yes
Central Texas Neurology Consultants
Y N N N
Yes
Christiana Care Health System - Newark, DE
Y Y Y Y
Yes
Dignity Health Sacramento (CA)
Y N N N
Yes
EvergreenHealth Medical Center (WA)
Y N N N
Yes
Georgetown University
Y Y Y N
Yes
Hackensack University Medical Center
Y Y N N
Yes
Holy Name Medical Center
Y N N N
Yes
Icahn School of Medicine at Mount Sinai
Y Y Y Y
Yes
Massachusetts General Hospital / Harvard University
Y Y Y N
Yes
Mayo Clinic
Y Y Y Y
Yes
Neurology Specialists of Tidewater / Meridian Clinical Research
N N N N
Yes
New York Presbyterian/Columbia University Medical Center
Y Y Y Y
Yes
New York University School of Medicine
Y Y Y Y
Yes
Northwestern University
Y Y Y N
Yes
Norton Neurology Services
Y N N Y
Yes
Ohio Health
Y Y Y Y
Yes
Providence Health (OR)
Y Y N N
Yes
Rush University Medical Center
Y Y Y N
Yes
Data as of 3/30/2018
Site FWA SMT IRB Exchange Portal LOI Subcontract Sent
Stony Brook University
Y Y Y N Yes
Swedish Medical Center
Y Y Y Y Yes
University of Alabama at Birmingham (UAB)
Y Y Y Y Yes
University of California, San Francisco (UCSF)
Y Y Y Y Yes
University of California, Los Angeles (UCLA)
Y Y Y N Yes
University of Cincinnati
Y Y Y N Yes
University of Florida, Gainesville
Y Y Y Y Yes
University of Kansas Medical Center (KUMC)
Y Y Y Y Yes
University of Louisville (KY)
Y Y Y Y Yes
University of Massachusetts
Y Y Y N Yes
University of Miami
Y Y Y Y Yes
University of Michigan
Y Y Y N Yes
University of Pittsburgh
Y Y Y Y Yes
University of Rochester
Y Y Y Y Yes
University of South Florida Health
Y Y N N Yes
University of Texas Southwestern (UTSW)
Y Y Y Y Yes
University of Utah
Y Y Y Y Yes
University of Vermont
Y Y Y N Yes
University of Washington
Y Y Y Y Yes
Vanderbilt University Medical Center
Y Y Y Y Yes
Wayne State University
Y Y Y Y Yes
Data as of 3/30/2018
Final S Step IRB C Ceding Ac Accept t the S e Study-Speci cifi fic c Rel eliance P e Plan
Start-up performance is the dress rehearsal for enrollment performance and overall study performance. A rapid start-up not only improves trial performance but helps everyone feel confident & good about a job well done. We will organize ourselves with a schedule of deliverables, an order of start-up events, and use general tools and processes to accomplish your TREAT-MS site activation Together, we will use an electronic time manager over the 90 days for easier communication and progress tracking.
sequential, time-sensitive objectives:
met to accelerate progress through the start-up phase and onto site activation
Month 1
IRB Submission & Contracts FWAs
Month 2
Collection of Essential Documents & IP Supply
Month 3
Training: Focus
Personnel
Site Activation
IM/SIV/Remote Commence enrollment FPFV
institutions in reaching monthly deadlines to achieve activation within 90 days and FPFV immediately following.
Our first month has been spread over 1.5 months
with your steps that take the longest.
Local IRB Submission Contracts & Agreements Delegation of Responsibilities Certifications Highest Risk Steps
Most setbacks in clinical trials occur during
these 4 activities
We will use checklists and methods to aid in
protecting efficiencies and avoiding delays.
Month 1
GO LIVE IRB Submission & Contracts FWAs
Month 2
Collection of Essential Documents & IP Supply
Month 3
Training: Focus
Personnel
Site Activation
IM/SIV/Remote Commence enrollment ACTIVATE (FPFV)
Remote Activations
Weekly ZOOM meetings
Staging our work plan
Checklists to map & gauge progress
Deadline compliance
Key: Weekly Zoom Meetings
Set up Zoom Meetings; slide presentation; IRB website; Contract routing; weekly goals table Global eTM access; Meeting with contract contacts-results IRB update IRB & Contract progress; plan Month 2 Delegation log; vision training; documents to collect & upload Document uploading; pharmacy (or device engineering) meeting 3-way call: setting up with pharmacy or clinical engineering Training plan and notifications to those to be trained Recruitment plan; screening plan Consent training Local in-service debriefing; Log of those trained Screening log practice and submission timelines
22
Staging is Key:
Sign In Time Out Sign Out Induction Room Operating Room PACU Induction Room Departure Checklist Operating Room Arrival Checklist Operating Room Departure Checklist PACU Arrival Checklist Pre-Start Up Go Live Site Activation
Prior to 90 Day Phase
Month 1 Month 2 Planning (Pre-Start) Checklist Month 1 Checklist Month 2 Checklist Month 3 Checklist Month 3
Low, et al. Surgical Checklist Start-Up Checklist
TREAT-MS
Email 1: Reminder of an Approaching Deadline
Subject Line: [Date and timestamp] – [study_id] [site_name] Deadline Approaching Your deadline for completing [insert_task_name] is
eTM and complete the activity or item(s). Click here to logon and review:
Email 2: Congratulations on a Completed Task
Subject Line: [Date and timestamp] – [study_id] [site_name] Task Completed Congratulations for completing [insert_task_name]! We thank you for your continued vigilance and dedication to the site startup process. Please visit the Mount Everest Tab to view your latest score and placement on the climb! [insertmt Everest link here]
Table 1-1. Figure 1-1 represented as a table. Please see Appendices for monthly checklists. Start-up Activity: 3 Month Overview Month 1 Week 1 Local Context Review IRB Submission Week 1 Standard Agreement/ SOW / Contract Received by your Local Contracts Office Week 3 Local IRB Context Questionnaire (LCQ) signed and returned to CCC Week 3 Local Red-lined Contract returned to JHU Contracts Office Week 3 Remaining Start-up Activities Planned Month 2 Consent & Approval Documents Uploaded Regulatory (Essential) Documents Uploaded Pharmacy engagement and planning Month 3 Local Protocol Training Completed Note: It is assumed GCP Compliance Training (CITI) is in place before Go Live. Those without CITI training will have to be trained in Month 1. Local In-Service and Grand Rounds
We Start with What Takes the Longest!
Month 1 Week 1 Local Context Review IRB Submission Week 1 Standard Agreement/ SOW / Contract Received by your Local Contracts Office Week 3 Local IRB Context Questionnaire (LCQ) signed and returned to CCC Week 3 Local Red-lined Contract returned to JHU Contracts Office Week 3 Remaining Start-up Activities Planned
Be prepared to devote the first week to TREAT-MS
the most intense; the rest of the 90 day period will be easier.
Idea: Give this presentation and/or your guideline booklet to your team and your contracts administrators!
CTSA
agreement with Hopkins
Hopkins
status
Regulatory(Essential) documents collected in a specific order
Deploy Week 5 Upload or electronically sign
Week 8
Regulatory Documents
Training: Focus on local personnel
Training Modules
Online Training
Interactive features to enhance transparency and collaboration Retraining throughout the study
Grand Rounds & Nursing In-service
RELY ON COLLEAGUES TO SUPPORT TRIALS AND REFER PATIENTS
Your reward for three months of challenging work and herding others at your institution to stay
Activation! End of Month 3 End of Month 2 End of Month 1 First Zoom Telephone Call Receipt of Protocol and Contract
Navigator-Sherpas
sites will be you and your team!
Carolyn Koenig Amanda Bistran- Hall Sarah Lenington
Our r respon
as y you
CCC is to
ach chieve the k know-how
We c e can m make e it happen t tog
The system is dedicated to steadfast, orderly staging. We compartmentalize and concentrate on one month at a time. Stay loyal to the effectiveness of weekly meetings. Spread the word to your colleagues that you consider meeting the TREAT-MS 90-day timeline a professional responsibility.
process
us on track
parts first
contracts
partner
THANK YOU FOR AGREEING TO BE SUCH A MOTIVATED AND HIGH PERFORMING PARTNER !
Shannon Hillery Co-author of the Guidelines Ying Wang Software developer and builder in Prelude’s VISION™ Ryan Majkowski Software developer Cindy MacInnis Contributor to the IRB and contracts Guidelines & software Megan Singleton Contributor to the IRB Guidelines TIC PL, PMs, Navigators Reviews and critiques Site Managers who are disseminating this innovative package and platform to the trial teams!
May’s Monthly Webinar will be held on the 2nd at 3pm and 3rd at 9am Eastern