August 25, 2020
Meeting Presentation
Welcome to the August 25 CTRP User Call! The topics covered in the 08-25-2020 Presentation are as follows:
Discussion/Minutes
Pre-asked questions
- How should the LO report accrual in each of the following?
- Patient transfers INTO the lead org site from a participating site (the patient becomes a LO site patient treated by a LO site investigator)
- The patient would not have enrolled to the study under LO site investigators
- Patient transfers FROM the LO site to a participating site (the patient is no longer being treated by a LO site investigator at the LO site)
- The patient would have enrolled to the study under a LO site investigator
- How do I register an Observational study that doesn't have an NCT ID
(not registered in ClinicalTrials.gov)?- Please contact the CTRO NCICTRO@mail.nih.gov to request assistance with registering Observational studies without an NCT ID
- Is the inclusion of expanded access trials on the CTRP DT4 still optional?
- The reporting of an Expanded Access trial on a center-specific CTRP-generated DT4 is still at the discretion of the cancer center
- If you have an Expanded Access trial registered in CTRP that you would like to exclude from your CTRP-generated Data Table 4 report, please send a message to the CTRO (NCICTRO@mail.nih.gov) to request exclusion
- With expanded access protocols being in DT4, will single patient expanded access (compassionate use protocols) also be included?
- No, single patient compassionate use studies are out of scope for CTRP
Open Discussion
- What is the location on the Wiki to download ICD-O-3 code lists when there are updates?
- The number of observational studies without an NCT number is likely to be extremely high. Why are these being treated as one-offs?
- The one-off situations referred to here are only for industrial trials (not an Investigator Initiated or National Trial) that would be traditionally imported from ClinicalTrials.gov. For these instances where an NCT ID is not available, the CTRO currently has a mechanism to get the trial into CTRP, but this mechanism may be updated based on the scope of trials.
- How often, if ever does CTRP run a comparison of Center CTRP data against CT.Gov? I ask as we've had a recent issue where we are not the lead organization for an IIT, but our internal data matches that of CT.Gov. It does not, however, match CTRP and has created an inconsistency in our report.
- We do not formally compare all data between CTRP and ClinicalTrials.gov. For imported studies, we look at ClinicalTrials.gov to be the source of the trial level data. For non-imported studies (IIT and/or National studies), we look to the data submitter to provide any trial level data and updates. On an adhoc basis, the CTRO may contact the lead organization if there is an obvious reporting issue.
Can David also speak to how centers are to count a withdraw of consent prior to starting treatment? Should these count as an accrual reportable on the DT4?
- Currently, National Sources counts a patient once they have signed the consent, even if the patient is withdrawn at a later time. The CTRP team will discuss this topic with the Office of Cancer Centers to provide additional feedback.
David, will the Accrual API be affected by the switch to 2-part authentication?
- The authentication will change but 2 factor authentication will not be required because the API user will have a token with their authentication.
Additional Questions Asked During Meeting (answered during presentation)
- Meeting Logistics
- Is there a recorded version of this call available?
- No, this is not a recorded call.
- Will these slides be shared after the meeting?
- Yes, the slides are available for this and all previous CTRP User Call meeting minutes on the CTRP User Call Meeting Minutes Wiki Page (https://wiki.nci.nih.gov/x/7R2eAQ)
- CTRP Trial Registration and Scope
- Can you please clarify the registration of expanded access studies, should they be registered in CTRP or centers still have the option not to register them?
- CTRP still expects centers to submit expanded access trials in CTRP; but they should all be registered by importing the record into CTRP from ClinicalTrials.gov. A center still has the option tol flag these trials to have them be removed from their DT4 report.
- What if NCT ID is missing for expanded access?
- For any trials required to be imported (including expanded access) to CTRP without an NCT ID, please contact the CTRO (NCICTRO@mail.nih.gov). CTRO can confirm if this trial is in scope for CTRP and if so, will facilitate registration (slide 39)
- Are Single Patient Studies in scope for CTRP?
- No, single patient compassionate use studies are out of scope for CTRP (slide 40)
- So do we have to submit Ancillary/Correlative studies to CTRP?
- CTRP supports registration of Ancillary/Correlative studies. There is no current requirement to register these studies. (Slide 26)
- When should a cancer center that wants to submit for an initial CCSG award begin registering its protocols in CTRP?
- The center can start to register any grant funding as soon as possible, but they should hold off an any additional trials until the grant is awarded. The center should contact their Office of Cancer Centers (OCC) Program Director for specific questions.
- How can we access the list studies which has been not updated since last 6 months?
- This can be found in Registration (slide 13)
- If a study is imported from Clinicaltrials.gov - How soon can we see it displayed in out CTRP DT4. Also is there any additional information required to complete registration of study once imported from clinicaltrials.gov.
- Once the trial has been abstracted and site information has been updated, a trial would be available on a DT4 report.
- Verification Process
- For emails listing studies requiring verification, who will they be sent to?
- The email notification will be sent to the CTRP Point of Contact provided to the CTRO. To update this personnel, please contact the CTRO (NCICTRO@mail.nih.gov).
- Will we be able to download the list of trials that need record verification into a csv or excel report?
- Yes, there will be a download option for the trials requiring verification.
- Accrual Questions
- Regarding study accrual entry and the flexibility, my understanding is that a request to enter summary accrual has to go to a committee at CTRP. Why must we gain approval to provide summary accrual data for a non-treatment healthcare delivery research type of protocol.
- The current policy is to collect patient level accrual on all Interventional trials (even non-treatment trials). The exception to allow the partial level accrual would be on a case-by-case basis in for Interventional trials.
- Has there been any additional thought about 2 step studies, trials that include a screening and treatment component? These trials are becoming more frequent and the sponsors count both types of accrual steps. How are Observational multi-step accruals to be counted?
For Interventional multi-step trials, the Interventional step (not the screening step) would be counted for accrual (with the exception of MATCH, Alchemist, and Lung Map trials)
For Observational multi-step trials, the Observation step (not the screening step) would be counted for accrual.
- Other Topics
- The "Entire Study" column on the DT4 report is the only way for an Investigator Initiated Trial Lead Org receive "credit" for all accrual reported on the trial (other than accrual within the Center's family). How final is the decision to remove it for the CTRP DT4 PDF?
- This change was made in order to allow the CTRP-generated DT4 report to match the eRA commons size requirements for Competing DT4 submissions. The center also has the option to download the Excel version and create a PDF version to include this column.
- Would it be possible with the new updates to add the correction templates on the registration page?
- We need to be able to update open/close dates within a more narrow timeframe of six months. the NCI may think it's fine to have this type of discrepancy, but reviewers of our centers during competing will review our DT4 for low accruing studies. If a study open or close date is 5 months inaccurate, this can negatively impact our review if the data is inaccurate by that duration of time.
- For any trials that require a participating site update, please contact the CTRO (NCICTRO@mail.nih.gov) for assistance.
- If the lead org requests to remove an observational trial from DT4, How will the center report it?
- There are options for a trial to be removed from all DT4 reports (example, non-cancer trial) or to be removed from only certain participating sites (example, Expanded Access trial). If there is a concern with a trial that required a flag or a flag removal, please contact the CTRO (NCICTRO@mail.nih.gov).
Contact Links