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
4 additional sites have 5 additional sites were We have 5 sites IRB approval and are submitted to the IRB activated! close to being on 7/24. activated. 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 Study Updates 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 o 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 of 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 out? 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 or 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.
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