Monthly Webinar Series September 2019 Todays Agenda Announcements - - PowerPoint PPT Presentation

Monthly Webinar Series

September 2019

Today’s Agenda

Announcements & Trial Updates Sandi Cassard Monthly Randomization Race Amanda Bistran-Hall Recently Asked Questions about Biobanking Susan Emrich Q&A All

Announcements & Trial Updates

SANDI CASSARD

Study Updates – Enrollment

THANK YOU for continuing to screen and enroll patients! We have 46 sites activated and 287 patients enrolled as of 09/04/19! We hope that you are all refreshed from your summer vacations and the holiday weekend and have renewed energy for the trial! Please find at least 1 new candidate each week so we can accelerate enrollment!!!

Study Updates - Reminders

1) We will be amending subcontracts for the main study this fall, adding payments to the study budget for EDSS exams at the month 18, 30 and 42 visits. 2) Biobanking subcontracts are in process and we will pay for all blood draws that have been done at each participating site as soon as the subcontract is fully executed and PO is assigned. Susan Emrich, biobanking manager, will help your site generate the invoice to be paid. THANK YOU for continuing to enroll and draw samples for the biobanking substudy!

Study Updates – Month 18 and 24 CRFs

Please visit the study website: http://treat-mstrial.org to download case report forms (CRFs) for your upcoming month 18 and month 24 visits.

Study Updates – Save the Date

Next SAC Conference Call Friday, September 27, 2019 1:00 – 2:00 pm EDT

Study Updates – Save the Date

Next in-person SAC Meeting Wednesday, February 26, 2020 1:30 – 5:00 pm EST Hilton West Palm Beach, Florida (preceding ACTRIMS meeting)

Monthly Randomization Race

AMANDA BISTRAN-HALL

Monthly Randomization Race

August’s Top Performers:

Site Randomizations

Johns Hopkins Hospital 5 University of South Florida 3 University of California at Los Angeles 2 Swedish Health Services 2 Cedars Sinai Medical Center 2

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

2 Baylor Research Institute 2

August’s Top Enroller:

University of South Florida

$50

Recently Asked Questions About Biobanking

SUSAN EMRICH

Recently Asked Questions (RAQs) and Answers for the Biobanking Substudy

1) Timing and labeling Baseline and Month 6 samples 2) Blood draws at Subsequent Visits 3) Shipping Ambient Samples to UAB 4) Vision Database Entries

Biobanking Substudy RAQs

Question: If a patient consents to the biobanking substudy but no sample was drawn at the Baseline visit, can samples be collected at a future visit? How should the visit be labeled on the tubes and in VISION? Answer: Yes! If the patient returns for an interim visit (e.g., month 3 clinic visit or infusion visit), the sample should be collected and labeled as a Baseline visit sample. It is appropriate to label it as a Baseline visit sample, even if the patient has already started on a DMT.

Biobanking Substudy RAQs

Question: If a patient did not initially consent to biobanking and has started a DMT, can they still join the substudy at a later time? Answer: Absolutely! A patient can consent to participate at any time during the main TREAT-MS trial. Once consented, please draw blood at the earliest opportunity. If the patient has been enrolled in the study for less than 6 months, label the visit/samples as Baseline. If it has been greater than or equal to 6 months, but less than 1 year after enrollment, label the visit/samples as Month 6.

Biobanking Substudy RAQs

Question: Please clarify the timing of the Month 6 blood draw? Answer: The Month 6 blood draw should be included as part of the routine Month 6 clinic visit and is not dependent on DMT start date.

Biobanking Substudy RAQs

Question: In addition to the Baseline and Month 6 blood draws should we draw again at the Month 12 visit? Answer: Additional blood draws should only occur if there is a switch in DMT due to breakthrough disease. The additional draw should occur at the time of DMT switch (at the visit when a decision is made to change DMT) and again six months after being on the second DMT.

Biobanking Substudy RAQs

Question: If a patient consents to the biobanking substudy, what do I enter in the VISION database? Answer:

Biobanking Substudy RAQs - Shipping

Question: Will you please review what information goes in the shipper to UAB? Answer: For each participant visit requiring a blood draw, the coordinator will prepare a specimen transport bag containing the needed blood collection tubes, labeled with the TREAT-MS ID (XXXX- YYY), visit date (DDMMMYY – eg: 05SEP18) and type of visit (BL, M6, SX, or ES). Coordinators will also complete a Biobanking Specimen Card that will be included with the shipment. A copy of the completed card should be made and stored with the patient’s CRFs.

Biobanking Specimen Card

Biobanking Substudy RAQs - Shipping

Shipments should be sent on Monday – Thursday only. No Friday shipments should be sent. Call FedEx (1-800-463-3339) to arrange same day pickup.

Biobanking Substudy RAQs - VISION

Question: What information should be entered into Vision database when a sample is collected? Answer:

• Date consented to optional biobanking substudy: DD-MMM-YYYY
• Confirmation TREAT-MS optional biobanking substudy consent form has been uploaded to

Source Docs in Vision EDC

• Type of visit (BL-baseline, M6-month 6, S1-switch of DMT, S2-6 months after start of 2nd DMT,

S3-next switch of DMT (if applicable), S4-6 months after start of 3rd DMT (if applicable), and ES- end of study)

• Draw Date: DD-MMM-YYYY
• Draw Time: HH:MM
• Specimen # (starting with 1)

Biobanking Substudy RAQs – VISION

• Last Meal Date: DD-MMM-YYYY
• Last Meal Time: HH:MM
• Total Number of Tubes Drawn: __ Red __ Purple __ Green
• Process/Ship Date: DD-MMM-YYYY
• Prepared/Shipped by: ______________________________

Open for Questions

Thank You for attending today’s webinar!

The October Monthly Webinar will be held on the 2nd at 3 PM and 3rd at 9 AM EDT