Monthly y Webinar Se Seri ries August, 2018 To Todays Agenda - - PowerPoint PPT Presentation

Monthly y Webinar Se Seri ries

August, 2018

To Today’s Agenda

• Announcements and Trial Updates

Christina Grabarits

• Patient Retention

Ellen Mowry

• Recently Asked Questions from Sites

Sandi Cassard

• Mt. Everest

Christina Grabarits

• Q & A

Team

An Announcements

Webinar Surv rvey

Please take the time to fill out our webinar survey. Through your responses, we hope to find the best time frames to hold our webinars. The intention is to keep Wednesday at 3 pm and determine if a better option exists for the second broadcast. Thank you!

Ac Activated Sites

Re Recent Enrollments

St Study udy Upda Updates

Study Updates

We have 5 sites activated! 4 additional sites have IRB approval and are close to being activated. 5 additional sites were submitted to the IRB

• n 7/24.

Study Updates

We have 12 patients enrolled, including one at Christiana Care! We have received additional funding for the biobanking substudy! Protocol version 1.8 and Consent form version 1.2 that include the biobanking study have been submitted to the IRB for review. Once approved at Johns Hopkins, consent forms will be revised for all sites and if sites are participating in the biobanking substudy, patients will be able to opt in or out of the substudy. Additional funding will support the biobanking substudy effort and provide the supplies / shipping materials. Stay tuned for more details!

Pa Patient Retention

PI: DR. ELLEN MOWRY

Re Retaining Patients: What’s the Big Deal?

Major threats to the study if patients are lost!

These include:

• LOSS OF POWER
• The study’s sample size reflects the # of patients required in order to demonstrate a meaningful difference between the study

treatment strategies

• More than anticipated loss to follow-up threatens the whole study’s integrity in that there may no longer be adequate power to

detect a difference in strategies EVEN if it is truly present

• Undermines the entire study and leaves us… where we are now, in terms of knowledge to help those with MS
• BIAS
• Loss to follow-up may not be random; perhaps those who are randomized to one arm more likely to be disabled (or less

disabled) are those who are not retained n the study

• This means the conclusions of the study may be flawed
• E.g. if a large # of people who are assigned higher efficacy medication had highest risk for disability, and they

disproportionately drop out… the effectiveness of the higher efficacy medications will be falsely elevated

Pa Patient retention

EVERY P ATIENT COUNTS!

Bu Built-in in r retentio ion s strategie ies

• Tie study visits to standard of care visits
• Few study activities other than standard of care
• Offer payments to participants for completing study visits and online questionnaires
• Obtain multiple contacts to minimize true loss to follow up

Sit Site-Sp Specific ific M Mechan anis isms t to M

• Maxim

imiz ize R Retention ion

All team members A great relationship with the study team, and in particular the study coordinator, is of critical importance Emphasize that the study activities parallel those they would have anyways (e.g. timing of visits, MRIs, etc) Thank participants; remind them of their contribution to the body of knowledge that will help the next wave

• f people diagnosed with MS

Treating physicians Continue to educate participants about MS and the importance of the study Study coordinators/clinic staff Balance kindness/flexibility with following to the best extent possible the clinical/study schedule

Input Input fr from si m sites: es: w wha hat w works f s for y you? u?

RAQ AQs from Sites

SANDI CASSARD

Re Recently Asked Questions (RAQs)

• Q: Is the version number on the worksheets correct?
• A: Yes, the worksheets are version 1.0. This version number will not agree with the protocol version /

consent version numbers.

• Q: Are current meds just what they are on at the time of the visit, or do you

want to go back for a specific time period?

• A: Current meds are just what they are on at the time of the visit (we do not look back 30 days and

capture any medication d/c’d in the past 30 days).

• Q: How far back in time should a coordinator ask to capture the MS-DMT?
• A: MS-DMT should start with the new medication prescribed after randomization into the study.
• Q: Is there an AE form?
• A: Yes, the AE form is only used after the baseline visit, but for patients that split their

screening/baseline visit into 2 visits, it is possible for an SAE to happen in-between the visits.

RA RAQs Qs

• Q: If a site obtains a dummy run on the first patient, is it billed to insurance or does the

study pay?

• A: Both. The MRI is a standard of care MRI that should be billed to the patient’s
• insurance. The start-up payment for each site includes $1000 for the first dummy run

MRI, but that is mainly to cover the cost of the technologist’s time in making sure our preferred sequences are included and making adjustments/communicating with our imaging lab. It also may be used to cover some of the coordinator’s time in making sure the patient is scanned on the correct scanner.

• Q: If a patient walks in to the baseline visit with an MRI from an outside hospital,

that can be a dummy run?

• A: Unlikely. We still want that baseline MRI uploaded to the EDC as the patient’s baseline

MRI if it will not be repeated. An enrolled patient that needs a new baseline MRI for clinical purposes could serve as the dummy run MRI if it is done on a 3T scanner with sequences that conform to the specifications in our MRI manual.

RA RAQs Qs

• Q: Do sites upload the Confidential Contact Information? Do they have to fill it
• ut? Some sites feel they have all of that information in the medical record.
• A: The confidential contact form is for sites’ use only and will not be uploaded. As long as the medical

record has both a next of kin and contact information for two additional people not living with the patient, sites are not required to use it. That being said, it is a key feature of our plan to prevent loss to follow-up.

• Q: Am I able to use the source docs that is provided on the TREAT-MS website for

my own source docs without any repercussions? Usually we would have to make up our own when none is available, but since your site provides them are they at my advantage to use?

• A: Absolutely – we created them for the sites to use!

RA RAQs Qs

• Q: How detailed does the Medical/Surgical history need to be? Can you define

abnormal? How far back in time should they capture this information?

• A: Per a typical history that a doctor takes at a clinical encounter, the doctor will ask the patient about

past medical history. The doctor is responsible for creating the documentation thereof. We give some leeway here because we are not going to reject the doctor for not documenting something like “frequent colds” if the patient reports it, but the doctor doesn’t feel like this is truly a medical condition. We don’t expect coordinators to go digging though the EMR to see if they can “catch” something that the provider missed. Since the baseline visit takes place within the standard of care visit, the past medical history that the provider/doctor documents as part of a routine clinical visit is appropriate.

• Q: We were going through the source documents in TREAT-MS and the alternative SDMT #2 does

not have a Symbol sheet, it only has the scoring sheet. Is it possible to send us a correct copy of symbol and scoring sheets?

• A: We will upload the SDMT #2 symbol sheet when we provide the month 12 CRFs. Our research

manager is out for the next 3 weeks and will finalize the follow-up forms in the last part of August. You won’t need this form for quite a while.

RAQ AQs

• Q: Can I create my own source/worksheets to supplement the ones provided? For

example, create one AE form per AE event. This way I can have the physician review/sign each event and there isn’t risk of losing a log with multiple AEs each time I have the physician review a new AE?

• It is fine if you want to modify the source or develop your own, as long as it captures what we are looking for

in the EDC. Please note that we are not collecting every AE, but rather only those that lead to a dose change

• r treatment discontinuation. We are also not capturing all SAEs- for example, hospitalizations that are

elective or for MS relapse will not be considered an SAE. Notably, relapse is an OUTCOME, not an AE, for this trial.

• Q: Can I add/adjust the provided source/worksheets? For example, I would like to add a

space for the physician to sign and date (not just initial) on the eligibility page and if the patient comes in for a screening and baseline visit on separate dates, I would like to have a space for the physician to sign twice on eligibility (once on each date). Or- can they just sign and date where it says initial?

• It is fine to collect signatures and dates if that is what you prefer, rather than initials. Up to you to use the lines

for initials or add to it.

RA RAQs Qs: Bi Biobanki king

• Q: Are sites biobanking? Will they be?
• A: Biobanking will be an optional substudy that was recently approved for funding. We hope all sites will

participate, but it is not an active part of the study yet (was just added to the central IRB application)

• Q: Regarding biobanking, is Johns Hopkins providing the supplies for it? Will we

be shipping out the same day or batching here?

• A: Yes, we will provide the supplies for drawing blood and shipping. The majority of tubes collected will

be shipped ambient the same day, without any processing. We will ask you to spin tubes for serum aliquots and freeze them locally, batch shipping these on dry ice at a later time.

• Q: Is there a protocol amendment to accompany this updated ICF?
• A: Yes, protocol version 1.8 includes a description of the biobanking substudy. This is currently under

review by the central IRB.

RA RAQs Qs: Recruitment Material

• Q: Can I get “editable” recruitment materials so I can insert a POC? I can’t seem to do

that with the docs that are on the treatms-trial site.

• A: We have printed labels with the POC details and placed them on the printed recruitment material

(We used Avery 5260 labels). Then, you can photocopy the new “original” for your site to avoid placing stickers on every piece.

RA RAQs Qs: Labs

• Q: Do all patients need to undergo HIV, HBV, HCV, JCV, and Tb testing?
• All patients need to have had a documented negative HIV test in the past 12 months. If this is already available

through the medical record, document the date it was negative. If no test was done/available, this should be done at the baseline visit.

• Otherwise, participants EITHER need a qualifying JC virus test results OR need to have the Hepatitis B&C and TB

testing requirements.

• Q: Are we randomizing patients before all the lab results are available?
• You DO have the capacity to randomize before the results are available if that’s what the treating

MD/patient/coordinator wish to do. In the unlikely event that the patient is excluded from the trial, s/he will be unrandomized and that randomization # returned to the pool (contact the JHCC)

RA RAQs Qs: : Ratin ing Materia ial l Questio ions

• Q: Are we only using PASAT form A and SDMT Form 1 for the whole study?
• We will provide SDMT form 2 and PASAT form B when we provide the month 12 CRFs. These should be ready the first week of

September and you won’t need them for at least a year.

• Q: Low-contrast vision: Per the source, we are only having the patient complete the 2.5 chart

(not 100% or 1.25)?

• Correct, we are only doing LCVA at 2.5%

RA RAQs Qs: : Dis Discontin inuatio ion and “E “End of Tria ial” l”

• Q: Can you please explain the assessments completed during “Discontinuation” from study?
• A: If a patient is withdrawing from the study and is willing to come in for another clinical visit, all

assessments that are expected at the month 48 visit should be done, if possible. At a minimum, we need the EDSS, T25FWT, 9HPT, PDDS and safety/adverse event assessment.

• Q: Can you please explain the assessments completed at “end of trial”? There is one

questionnaire to complete. Is the questionnaire sent by Vision? Can you please let me know the number of days/ weeks after month 48 visit that we complete EoT visit? Do we need to complete any other assessments?

• A: There is one more ePRO after the month 48 visit for patients enrolled early in the trial (PDDS). That

questionnaire will be requested from VISION. There is no EOT visit for patients that have completed the month 48 visit, only the EOT PDDS completed on-line.

The The M Moun unt E Everest C Climb mb

CHRISTINA GRABARITS

• You receive 1 point for attending these

webinars

• If you watch a recording of a webinar, please

fill out the webinar report under all of the recordings to receive credit

Activation!

The Summit

End of Month 3

Lhotse Wall

End of Month 2

Icy Lhotse Wall

End of Month 1

Valley of Silence

Receipt of Protocol and Contract

Base Camp

ELEVATION

Mount Everest Standings

*Not fit to scale

136.7 Christiana Care 125.3

• 1. Norton Neurology Specialists
• 2. Central Texas Neurology Consultants

121.9

• 3. University of Cincinnati

68.9 83.9 154.5 107.7

• 4. Columbia Presbyterian
• 6. Baylor Scott & White Health

NYU School of Medicine

• 7. Neurology Specialists of Tidewater

66.9 Advanced Neurology Specialists 108.3

• 5. Cedars Sinai
• 10. University of Washington
• 8. Vanderbilt University
• 9. Stony Brook University

66 University of Vermont JHU

https://etm.preludedynamics.com

• Mt. Everest Route

Op Open for Qu Questio tions

Thank You for attending today’s webinar!

Encore Performance: Tomorrow 9am

September’s Monthly Webinar will be held on the 5th at 3pm and 6th at 9am Eastern