1. CTRP User Call October 1, 2014 Gene Kraus CTRP Program Director

2. Agenda Welcome CTRP Topics -Correcting Status -CTRP Trials -Value of CTRP -Review of Organizations in CTRP Detailed Demo of Accrual Submissions into CTRP

3. Correcting Status in CTRP CTRO may be reaching out to centers to get correct status histories -As a follow-up to DT4 user calls it has been determined that a number statuses in CTRP need correction Site Admins should NOT be adding themselves or others as owners to NCI sponsored, PIO Managed trials.

4. Status Issues Users Can Correct Correct Status Date Issues During Verification Users should use change status in registry when: Correcting status dates, Verifying trial data, or When viewing TSRs

5. CTRP Trials

6. Trials in CTRP

7. Outreach Calls – Data Table 4 Reviews The CTRP Program Director, in coordination with the Program Directors from Office of Cancer Centers, is nearing the conclusion of calls to all NCI Designated Cancer Centers These “First Pass” calls have been comparing the Data Table 4 information generated from CTRP with the data submitted by the Cancer Centers in their CCSG DT4 reports Draft CTRP DT4 reports are shared with the Cancer Center following the call Centers are asked to review the questions that arise during the review of these draft reports and to get back to the CTRP Program Director in 2-3 weeks with an update on their review of the data presented.

8. Value of Clinical Trials Reporting Program (CTRP)

9. CTRP Will serve as a single source of verified information for NCI’s Clinical Trial portfolio management. Will contain information on clinical trials not available through other sources, e.g. Detailed accruals, Biomarkers, etc. Will enhance the CCSG Data Table 4 reporting by Cancer Centers Will be used as the source of truth for public information on NCI Supported clinical trials by Cancer.gov

10. Why Use CTRP for Data Table 4 Reporting?

11. Benefits of CTRP Data Table 4 Reporting Reviewing CTRP for DT4 helps to ensure information in CTRP is complete and accurate Reviews with Cancer Centers have identified trials not registered in CTRP and differences in trial status and accrual totals The Cancer Center Organizational Structure is used to create the CTRP Data Table 4 Report -Trials are listed if one or more of a Cancer Center’s organizations are listed as a participating site -Cancer Centers can determine if their National and multi- center trial participation is correctly represented to NCI -Accrual is reported for the Cancer Center and its affiliates with consistent summarization

12. Benefits of CTRP Data Table 4 Reporting Protocol and accrual information for a clinical trial in CTRP is provided by a single source NCI registers, amends, lists participating sites, and reports accrual on CTEP, DCP, CCR trials Cancer Centers: register, amend, list participating sites, and report accrual on Institutional trials Industrial and Consortia trials are imported from ClinicalTrials.gov Cancer Centers indicate their participation and their individual accrual on Industrial/Consortia trials Trial information is consistent between centers

13. Benefits of CTRP Data Table 4 Reporting Data Table 4 Reporting from CTRP ensures consistency across Cancer Centers reports Reduces potential for duplicate accrual reporting Consistent trial descriptions for Protocol ID, phase, title, and sponsor Example GOG-0086P vs GOG 0086P, GOG0086P, GOG 86P, GOG 86p, 0086-P, 0086P, 86P, 11-404, 09-115 Example: A Phase II/III Randomized, Multicenter Trial Comparing Sirolimus Plus Prednisone, Sirolimus/Extracorporeal Photopheresis Plus Prednisone, And Sirolimus/Calcineurin Inhibitor Plus Prednisone for the Treatment of Chronic Graft- versus-Host-Disease vs PH II/III (SRL + PDN, SRL + ECP + PDN) VS (SRL + CNI + PDN).

14. Benefits of CTRP Data Table 4 Reporting CTRP Data Table 4 reporting will improve Office of Cancer Center benchmarks -http://cancercenters.cancer.gov/data/Sum4c.htmlhttp://cancercenters.cancer.gov/data/Sum4c.html -Example: Total Number of Therapeutic Open Trials 14,172 with footnote “* It is important to note that these are not necessarily unique trials; the same trial may be open at multiple centers.” Review of CTRP generated Data Table 4 reports for FY 2013 have identified 5,435 unique, interventional trials based on CTRP protocol ID mapping

15. Cancer Center Organization Structure in CTRP Review of Deb Hope presentation

16. Multiple Stakeholders Organizations in CTRP are part of the trial records for: -NCI-designated Cancer Center trials includes Institutional and industry-sponsored trials -CTEP-managed trials -DCP-managed trials -Center for Cancer Research (CCR)-managed trials CTRP trial records are used by: -ClinicalTrials.gov -Soon, Cancer.gov National trials

17. Multiple Sources of Organizations Sources of Organizations in CTRP -CTEP Enterprise Core Module (ECM) CTEP ECM is the provider of NCI Organization IDs (CTEP-ID) CTRP and CTEP share organization data -Cancer Center Users can request a new organization using the Registry application -Clinical Trials Reporting Office (CTRO) part of the administrative abstraction process -ClinicalTrials.gov imported industrial trials can contain organizations that are new to CTRP

18. Duplicate or Variant Organizations Many Centers have multiple “variants” of an organization -Makes it challenging to select the correct organization to associate with a trial. -Creates a situation where a single organization could be represented as different organizations on different trials Not all “variants” are redundant -There are organizations within CTRP that may not be directly relevant to Cancer Centers but are needed by the other stakeholders, e.g., CTEP, DCP, CCR -Harmonization between groups may necessitate these variants remain in place

19. Organization Clean-up Requires Cancer Center Input CTRP has a dedicated team of Curators (lead by Deb Hope) that manage the organizations in the system. Curators need feedback from the Cancer Centers to determine which organizations should to be retained and which should be removed Curators are working with cancer centers individually to determine the need for, and use of, organizations related to their cancer center family that appear to be redundant -Do these organizations represent functionally distinct organizations to a Cancer Center user or can they be consolidated? is it a name permutation? a nickname? alternative name? is it a new name for an existing organization? does it need to be a distinct organization in CTRP?

20. Clean-up also involves Data Harmonization with CTEP Curators are also working with CTEP to harmonize Organization with the CTEP-ECM system -for example, there are some organizations within CTEP ECM that have been merged with other organizations -these organizations will need to be “merged” in CTRP as well -There are organization within CTEP-ECM that may not be used by the CTRP people at the cancer center but are necessary for trials managed by the CTEP-PIO These need to remain so trial information imported from CTEP map correctly into CTRP

21. Organization Families in CTRP Cancer Center Organization in CTRP by Families -A Family consists of a set of organizations (and relationships) specified by the Cancer Center One family for each NCI Cancer Center -Are named as specified by the Cancer Center The family is not an organization -Are used in the creation of the CTRP Data Table 4 Report For a trial to be included on the DT4, the organization associated with the trial must be part of the Cancer Center family The relationship determines the column where the accrual counts will be reported in the Data Table 4 report -Can be used to manage access for loading accrual Accrual access can be granted by: trial, organization or FAMILY.

22. Family Clean-Up May Affect Other Cancer Centers Although the evaluation of organizations will occur at the family level, the data clean-up has the potential to affect other cancer centers -If your organization is currently the Lead Organization on a Multicenter trial and you have responsibility for loading accrual for that trial, one or more of the participating sites on your trial may be affected by the data clean up

23. “Removal” of Organizations from CTRP “Removing” an existing organization record is accomplished by nullification (inactivation) -Requires two organizations -Acts like a merge - one organization is retained and the other is nullified -The nullified organization will no longer appear in user searches

24. Consequences of Nullification Organization Nullification (Inactivation) -Accrual is NOT automatically transferred The CTRP team is investigating several options to try and automate the transfer of accrual from the nullified organizations to the retained organization for the appropriate trials This will address accrual currently in CTRP (legacy accrual) -Accrual loading to trials after the nullification of the organization will require that the Cancer Centers load future accruals to the retained organizations Curators will provide a comprehensive list of all organizations affected (created in Phase 1): −If you had been using Organization X now use Organization Y

25. Next Steps Curators have begun to work individually with Cancer Centers, and over the next month would like to review the details of the organizations associated with their families -send an email to ncictro @mail.nih.gov ncictro @mail.nih.gov subject line: Family Data Clean-up “Your Cancer Center Name” −Suggest a few convenient times for review -curators will provide a table showing the current state and the proposed state after clean-up Cancer centers can accept the proposed changes or discuss other options -the data clean-up will be coordinated so that is minimally disruptive to your workflow

26. Demo of Accrual Submission to CTRP Charles Yaghmour

27. In Conclusion CTRP Topics -Correcting Status CTRO will be reaching out to centers Cancer centers correct statuses and status dates when possible -CTRP Trials -Value of CTRP Value of CTRP to the NCI mission Value to the Cancer Centers Value to the public looking for clinical trial information -Organizations in CTRP Detailed Demo of Accrual Submissions into CTRP

28. CTRP 4.0.1 – User Guides CTRP User Guides https://wiki.nci.nih.gov/display/CTRPdoc/NCI+Clinical+Trials+Reporting+Program +%28CTRP%29+User%27s+Guides

29. Send questions / topics for future calls

30. Thank You