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CTRP Subcommittee

CTRP Subcommittee. John Speakman. Clinical Trials Reporting Program Subcommittee. Remit: Provide feedback on the Clinical Trials Reporting Program (CTRP) deployment effort and strategic guidance on issues/risks Dana-Farber presented on pilot experience

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CTRP Subcommittee

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  1. CTRP Subcommittee John Speakman

  2. Clinical Trials Reporting Program Subcommittee • Remit: Provide feedback on the Clinical Trials Reporting Program (CTRP) deployment effort and strategic guidance on issues/risks • Dana-Farber presented on pilot experience • Reviewed and provided feedback on the survey issued to the Cancer Center Administrators Forum (CCAF) • Cancer Center Administrators Forum (CCAF) members of the subcommittee surveyed member sites on opportunities/challenges for CTRP deployment • Outcome: Many centers are not aware of CTRP

  3. AACI Response to Meeting at NCI • Meeting was productive; slides were especially useful • Explaining CTRP • Outlining impact of FDA Amendments Act on Centers • AACI ready to assist NCI in communications • Recommended “strategically oriented committee” • Jointly chaired by AACI cancer center director and NCI representative • Committee Remit: craft plan to maximize centers’ ability to comply with CTRP • Address issues identified by sites • Make recommendations on timeline, deliverables • Discuss supplemental funding • Consider coordination with vendors

  4. NCI Proposal • Reformulate two existing committees • “Pilot Site Committee” will become a broader committee to address operational issues only • CTRP Subcommittee will discuss strategic issues only • NCI Chair: Sheila Prindiville, M.D., Director, NCI Coordinating Center for Clinical Trials • AACI Chair: Kevin Cullen, M.D.,  Director, University of Maryland Greenebaum Cancer Center • Members of each existing subcommittee will be asked to identify committee to join • Two cross-committee liaisons

  5. Teleconference with Deborah Zarin, M.D., Director, clinicaltrials.gov – May 13, 2010 • Presentation: FDAAA and clinicaltrials.gov basic results reporting • Tables are “constructed” by the data provider • Columns are pre-set as study arms, but can be changed by the data provider • Rows are measures—some are pre-set, others are customized for each study • Type of measure determines specific design of “cells” • Attempt to balance fixed structure with flexibility • Tables should convey study design, conduct and analysis

  6. Design Requirements • Display consists of data tables with minimal text—therefore, must be self-explanatory • System must accommodate range of study designs and facilitate comparison across studies • NLM directed to: • Consider different methods of display based on principles of risk communication for different audiences • Ensure the data are searchable in many ways • Structured data entry required to facilitate search and display needs 6 6

  7. Design Features Tables are “constructed” by the data provider Columns are pre-set as study arms, but can be changed by the data provider Rows are measures—some are pre-set, others are customized for each study Type of measure determines specific design of “cells” Attempt to balance fixed structure with flexibility 7

  8. Participant Flow “A table ..., including the number of patients who dropped out of the clinical trial and the number of patients excluded from the analysis, if any.” [Sec. 282(j)(3)(C)(i)]

  9. Baseline Measures “A table of the demographic and baseline data collected overall and for each arm of the clinical trial…” [Sec. 282(j)(3)(C)(i)]

  10. Outcome Measure “…a table of values for each of the primary and secondary outcome measures for each arm of the clinical trial…” [Sec. 282(j)(3)(C)(ii)]

  11. Statistical Analysis “…including the results of scientifically appropriate tests of the statistical significance of such outcome measures.” [Sec. 282(j)(3)(C)(ii)]

  12. Serious Adverse Events “A table of anticipated and unanticipated serious adverse events grouped by organ system, with number and frequency of such event in each arm of the clinical trial.” [Sec. 282(j)(3)(I)(iii)(I)]

  13. Certain Agreements “Whether there exists an agreement (other than an agreement solely to comply with applicable provisions of law protecting the privacy of participants) between the sponsor or its agent and the principal investigator (unless the sponsor is an employer of the principal investigator) that restricts in any manner the ability of the principal investigator, after the completion date of the trial, to discuss the results of the trial at a scientific meeting or any other public or private forum, or to publish in a scientific or academic journal information concerning the results of the trial.” [Sec. 282(j)(3)(C)(iv)]

  14. How Are Results Reported? Tables are “constructed” by the data provider Columns are pre-set as study arms, but can be changed by the data provider Rows are measures—some are pre-set, others are customized for each study Type of measure determines specific design of “cells” Attempt to balance fixed structure with flexibility 14

  15. Lessons Learned from Early Submissions of Basic Results • Data Providers must be able to understand the study design and data analysis • Typically, the investigator and a statistician will need to be involved • Multiple iterations with the QA staff are wasteful of everybody’s time • Careful attention to criteria would save time • Internal QA prior to submission helps! 15

  16. Meeting to Develop a Bank of Outcome Measures for Cancer Clinical Trials • Proposal: one day meeting of cancer researchers and other interested parties • Summer of 2010 at NIH • Goal: develop a “bank” of commonly utilized measures that researchers could use when reporting their studies to ClinicalTrials.gov. • “Bank” would serve as a source for standard language that could be used in ClinicalTrials.gov entries • Sponsor would only have to enter deviations from the standard language • This committee would need to identify and supply a group of domain experts

  17. CTRP Update Joseph Martucci Interim Program Manager, CTRP Coordinating Center for Clinical Trials National Cancer Institute

  18. Monthly Summary of Submissions

  19. CTRO Metrics • Metrics January 2009 to date (excluding CTEP/DCP) • Original Submissions 2077 • Accepted 1871 • Abstracted 1620 • QC 775 • Trial Summary Report Sent 530 • Abstraction Verified 171 • No response 205 • Submitted amendments 94 • CTEP/DCP • Original submissions 944

  20. CTRP Functional Roadmap 2010 2011 2012 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Milestone: All grantees able to register protocols in CTRP Accrual Pilot CTRP 3.2 Technical and Feature Enhancement release CTRP 3.3 Accrual Data Interface Milestone: All grantees able to enter accrual in CTRP CTRP 4.0 Outcomes Pilot CTRP 4.1 Outcomes Data Interface Milestone: All grantees able to enter outcomes in CTRP Complete CTRP integration with CTEP, DCP, Cancer.gov Milestone: Integration of NCI Clinical Trial Systems

  21. Proprietary/Non-Proprietary Registration • In December 2009, CTRP was enhanced to allow for proprietary trial registration • Definition: A trial with a contractual obligation that restricts sharing of the protocol document. • Protocol document not required on proprietary trial registration • Interpretation of proprietary varies by center

  22. Proposed Categorization of Submissions to CTRP • Category – Proposed Definition • Protocol Required? • National – National Cooperative Group Trials • Yes • Externally Peer-Reviewed – RO1s and PO1s or other trial mechanisms funded by NIH • Yes • Supported by other peer-reviewed funding organizations (e.g., Komen Foundation • Yes • Institutional – In house trials authored or co-authored by cancer center investigators and undergoing scientific peer-review solely by the Protocol Review and Monitoring System of the Center. The center investigator should have primary responsibility for conceptualizing and designing the trial and reporting results. It is acceptable for industry and other entities to provide some support (e.g., drug, device, other funding) by the trial should clearly be the intellectual product of the center investigator. • Yes • Industrial – Design and implementation of the study is controlled by the pharmaceutical company • No Example

  23. Near Term CTEP and DCPIntegration Goals • Update CTEP and DCP trial information in CTRP • Change processes so that all new CTEP and DCP trials are registered in CTRP • End CTEP and DCP registrations in PDQ • Update CTRP with CTEP and DCP participating site information from RSS • Continue to provide participating site information from RSS to PDQ for Cancer.gov

  24. Before FDAAA Single source of information updates for CTEP and DCP trials. Record in ClinicalTrials.gov owned and maintained by PDQ Responsible Party  New Trials and Amendments  CTEP/DCP PIO –New Trials and Amendments PDQ  Clinicaltrials.gov  PDQ Sites –Site and IRB INFO RSS-Site and IRB info –New Trials and Amendments PDQ  Clinicaltrials.gov  PDQ CTEP/DCP PIO New Trials & Amendments Responsible Party Site and IRB Info Sites RSS Site and IRB Info New Trials & Amendments PDQ XML nightly update ClinicalTrials.gov Registration ClinicalTrials.GOV

  25. Large volume of participating site status changes on CTEP/DCP trials • RSS integration with PDQ allows nightly automated update of participating site information • Not feasible to maintain this manually

  26. Short Term: New Cooperative Group Trials Registration • Responsible Party • --New Trials CTEP/DCP PIO • --New Trials Cancer.gov (PDQ) • CTRO/CTRP  Responsible party •  ClinicalTrials.gov CTEP/DCP PIO New Trial Responsible Party Same trial abstracted twice (To ensure cancer. gov is up to date) Site and IRB Info Sites RSS XML sites info TSR & XML Direct Trial Registration and updates (xml) New Trial New Trial CTRO/ CTRP cancer.gov (PDQ) ClinicalTrials.GOV

  27. Cooperative Group TrialsRegistration – Q4 2010 Automated interface between ClinicalTrials.gov and CTRP for non-NCI supported Cancer Trials. • Responsible Party • –New Trial  CTEP/DCP PIO –New Trial or Amendment CTRO/CTRP •  Cancer.gov (PDQ) • Responsible Party • --Direct Trial Registration and Updates  ClinicalTrials.gov – Cancer Trials w/o NCI Support  CTRO/CTRP CTEP/DCP PIO New Trial Responsible Party Site and IRB Info Sites RSS TSR & XML Automated interface Between ClinicalTrials.gov and CTRP for non-NCI supported Cancer Trials. New Trial Or Amendment XML sites info Direct Trial Registration and updates (xml) CTRO/ CTRP cancer.gov (PDQ) Cancer Trials w/o NCI support ClinicalTrials.GOV

  28. Issues with Cooperative Group Trial Registration in ClinicalTrials.gov • ClinicalTrials.gov registration will be by the Responsible Party identified for each Cooperative Group trial • CTRP will eMail Trial Summary Report and XML to Responsible Party to facilitate registration • Time to register in ClinicalTrials.gov should meet FDAAA(21 days after the first patient is enrolled) and ICJME (registered before the enrollment of the first patient) • Record in ClinicalTrials.gov will be owned by Responsible Party and cannot be updated by NCI systems • How will participating site information be created and maintained in ClinicalTrials.gov?

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