General Questions
Will Groups receive a central patient ID?
- There will be a Screening Protocol Participant ID and a Treatment Protocol Patient ID. There will not be a central Patient ID.
What is the mechanism for transfer of the three separate fields the protocol ID, cohort ID, and stratum ID to Groups randonode? What set up is needed on Group side?
- Groups will need to collect the screening protocol name, cohort, and stratum fields on the Treatment Protocol Eligibility Checklist (EC). These fields will be provided on the PMI Standard EC Template; this template will be available in the caDSR II and should be used to create the needed protocol-specific ECs. There will a validation check in OPEN that will verify that the enrolling site is being assigned to the treatment protocol for that location. The PMI Project team will provide a one-page document how to set up your RandoNode.
For crossovers from cohort 1 to cohort 2 (Group study EAY191-N2) are patients expected to submit PMI Off Treatment standard form and go back to central study?
- N2 is not a crossover, it is a reassignment because the cohorts are based on prior drug exposure. Participants with progressive disease on regimen 2 on Cohort 1 are eligible to enroll to cohort 2 if they can be re assigned. A participant who enrolls on cohort 2 over WILL take a slot and be evaluated separately.
How long will it take for the patient to be able to come down the pipeline to re-enter our study as cohort 2 candidate? EAY191-N2 study will have a second eligibility checklist in OPEN for these patients.
- The reassignment will take 24 or less hours depending on what time the reassignment was completed. N2 is not considered a crossover. For crossovers, they are immediate. Crossovers were implemented as a Step 2 on the Treatment Protocols. The PMI Off Treatment Standard Form should NOT be completed for crossover, the patient should be registered to Step 2 on the Treatment protocol.
The sequence of events would be:
- [Site] Register patient to Screening protocol Step 1 in MATCHbox assigns to N4 and sends it back to OPEN.
- [Site] Register patient to N4 Treatment protocol Cohort 1 Step 1 in OPEN (Single agent regimen).
- Patient progresses.
- [Site] Register patient to N4 Treatment protocol Cohort 2 in OPEN on Treatment protocol Step 2 to Crossover. (Multi agent regimen.)
- [Site] Complete PMI Off Treatment Standard Form for N4 when treatment on N4 is completed.
- [Site] Perform one of the below
- Register patient for Screening protocol Step 1 in OPEN to get a new treatment assignment for said patient, OR
- Complete the PMI Off Study Standard Form for the Screening protocol.
If yes to above, how will patients on EAY191-N2 that discontinue treatment for reasons other than progression, go into Follow up, have a progression, proceed to crossover to cohort 2? How will that be handled since PMI Off Treatment form was submitted with a reason other than progression? Also, what about those to progressed but do not want to consent to cross over to cohort 2?
- The crossover is immediate. You cannot crossover or be reassigned if there is an AE of the single agent. Cannot be reassigned to a dual agent therapy if you had an AE on the single agent.
If patients need to go through central study when crossing from cohort 1 to 2, how is crossover from treatment 1 to treatment 2 within the same cohort handled like we have in NRG study EAY191-N4? At what point PMI Off Treatment standard form needs to be submitted?
- Crossover is for disease-based cohorts and going from cohort 1 to cohort 2 is for drug exposure-based cohorts. The latter requires reassignment. For crossover, once they have enrolled to the first step and gotten their treatment assignment and patient progresses, they are eligible for a crossover.
- They would:
- Enroll to step 2 on the treatment protocol
- Assign a crossover treatment
OIDs should be abbreviations of the form, is there any way to keep this in mind in the future and for any forms that aren’t finalized yet?
- Westat can change the Form OID in Rave once they have the ALS from caDSR. Moving forward for PMI forms, the form OIDs will be abbreviated. Current ones will not be changed.
What’s the quickest way to get a form builder account for NCIs new system?
- The best thing to do is to contact caDSR.RA@mail.nih.gov so we can respond and assist. Everyone that had a Form Builder account in the old system has one in the new system, but we will need to work with them to make sure they can sign on and request curation if needed.
Where (what folder) does this EC template need to be in? Can it be in the Enrollment Folder with the other enrollment forms (Demography, Step Information, and Treatment Assignment)?
- The EC template can be placed in the enrollment folder.
For the ineligible status, is there a new field to use to ensure proper set up?
- This test case is now optional.
What is the form OID for the EC template?
- Form OID will be part of their form build in caDSR II.
How are the permissible values for the Cohort and Stratum CDEs added for each treatment trial? Are we responsible for submitting a request to the CBIIT curation team or will these be added in another way to ensure screening trial and treatment trial groups are using the same permissible values?
- Cohort and Stratum are being populated in OPEN through a group lookup window that is being populated with the Cohort and stratum that was assigned to the patient at screening.
- No curation activities are required or should be managed for the Cohort & Stratum CDEs/ fields. These are non-enumerated fields that should be used as already specified on the PMI EC Template.
ComboMATCH Questions
Our studies have a planned follow up after the treatment completion and PMI Off Treatment forms. These will be used to roll out follow up folders in Rave. Will NRG receive information that a patient is assigned to a different ComboMATCH protocol, and will we receive notification our follow up should be stopped?
- No, the Groups will not receive information that the patient is assigned to a different ComboMATCH protocol. MATCHbox will send an email notification to the enrolling site when assignment is confirmed for a patient. Also, no email notification will be sent to the groups if a patient goes off treatment, or if a patient is reregistered and assigned to another protocol.
Does NRG need to share data from our ComboMATCH studies? Is there a mechanism for that and in what format our data needs to be?
- As long as the Group returns the treatment arm that matches what is in the protocol. For treatment assignment, Groups can send assignment name. However, for OPEN you need the codes. This information will be added to the Randonode document.
What is the max number of steps to build into ComboMATCH. Has this been determined already?
- NCI still currently working on re-registration requirements.
