Learning Center
Plans & pricing Sign in
Sign Out



									NCI’s Clinical Trials Reporting Program

Program Update

                    caBIG® CTMS Workspace
                         September 28, 2010

                                      David Loose
                               Essex Management
                              Contractor, NCI CBIIT

Origin: Clinical Trials Working Group (2005)
 • NCI Trial/Study Analysis
    • How many new/ongoing
    • Number of studies by type,
      center, etc.
 • Trial/Study Performance
    • Accruals (#patients enrolled)
 • Trial/Study Effectiveness
    • AEs
    • Outcomes
Rationale for a Clinical Trials Reporting
 •   NCI has no electronic database for more
     than half of its clinical trials portfolio (>
     20,000 patients accrued per year)
        • R01s, R21s, P01s, SPOREs etc.
        • Institutionally-supported using CCSG
 •   Currently available databases do not allow
     NCI and the broader cancer community to:
        • Identify toxicity trends for public safety,
        • Manage portfolio accountably by
          monitoring accrual, identifying gaps and
          duplicative studies
        • Effectively prioritize clinical trials
Value-Added of NCI’s CTRP Registration
     2005: Voluntary        2007: FDAAA requires        2009: CTRP enhanced
•   2005: Voluntary registration from NCI Registry     registration and            to abstract information
     registration from      outcomes by                 for
     • Grantee  Registration  NCI Trials Registry (PDQ) 
     NCI Registry           Responsible Party. NIH      registration and return
•   2007: FDAAA requires registration and outcomes by for
                            policy prohibits            file to Grantees
                            NIH policy any              independent by any
    Responsible Party. registration by prohibits registrationvalidation
                            Federal System              and submission
    Federal System
     •       Grantee                    Grantee                   Grantee
          Grantee  NCI Trials Registry (PDQ) X
• 2009: CTRP enhancedRegistration
   Registration           to abstract information for
                                              Registration registration and return file to Grantees for
  independent validation and submission              NCI Trials
               NCI                         NCI
          Grantee  Registration  NCI Trials Registry (CTRP)  TSRRegistry (CTRP)
                                                                   XML  Grantee 
          Registration                       Trials
             Registry                      Registry                  TSR
              (PDQ)                      (PDQ)

Long Term Vision – Single Database
        NCI-designated                                   Industry and                    Industry
        Cancer Centers and                                 Industry and
                                                         other Non-NCI                   sponsors
•            NCI-designated
    NCI-Designated Cancer Centers, Cooperative Group andIndustry and
           Cancer Centers and                                 other participating sites 
                                                           other Non-NCI                 register     NIH/NLM
     •  otherNCI-designated                              SponsorsNon-NCI trials
         NCI Staff enter clinical trial information  NCI Sponsor (CTEP and DCP)
             Cancer Centers and                              other
     •     otherNCI-designated
         NCI Participating Site and IRB Management (RSS)

        participating Centers and
               Cancer                                      Sponsors                                   Clinical
         NCI CTRP (Registration)
           participating Centers and                         Sponsors
         Site Registers with NIH/NLM  Unidirectional update of non-NCI trials only from to NCI Enterprise Services
•       sites other
    NCI CTRP (Registration)  Sites register investigator-initiated trials with CTRP, receive back XML files for
             participating Centers,
           sites other
    investigator initiated and Grant funded trials  NCI-designated Cancer Centers, Cooperative Group and
             sites Cooperative Group
    other Participating Sites
               sites other participating
                    and                                        Site registers with
•   Industry and sites Non-NCI Sponsors  industry sponsors register trials  NIH/NLM
                                                                                              Sites register investigator-initiated trials
                                                                                              with CTRP, receive back XML files for
                                                                                              investigator initiated and Grant funded

                                                                                                                                                                                   update of
                                                                                                                                                                               non-NCI trials
           NCI staff enter clinical trial
                                                                                                                                                                                   only from
                                                                                                                                                                                  gov to NCI
                                                                  NCI Participating                                                                                                 Services
             NCI Sponsor                                                                                                                                        NCI Public
                                                                  Site and IRB
             (CTEP and                                            Management                                        NCI CTRP                                    Trials Portal
             DCP)                                                 (RSS)                                            (Registration)                               (
                                                                         NCI Enterprise Services
CTRP Features
• CTRP 3.2 Released August 11, 2010
  • Partial save of information during protocol registration
  • Organizational Access to allow administrator and
    multiple submitters at an organization
  • PDF format TSR
  • On-demand generation of TSR/XML
  • Optional fields
  • Security enhancement and integrated with caGRID
  • Performance improvements in search
  • Batch registration improvements using organization IDs
CTRP Features (cont.)
• CTRP 3.3 scheduled for November 18, 2010
  • Timely updates of CTEP and DCP trials in CTRP
  • CTRP and CTSU RSS system are being integrated
    to allow for easier and more complete capture of
    trial participating site data in CTRP
  • CTRP information export to
  • Summary 4 Type reporting (pilot)
  • Additional support will be provided for external
    vendors and sites that want to integrate with the
    CTRP trial registration services
  • Faster searching
CTRP Features (cont.)
• Future plans - 2011
  • Batch and service specifications for patient level
    accruals (based on CDUS Abbreviated)
  • UI, batch, and service specifications for Outcomes
     • Working with cancer community to align requirements
       from CDUS Complete, Basic Results Reporting, Patient
       Outcomes Data Specification
  • Observational/Ancillary/Correlative studies
  • Integration with CDMS program for accrual and
    outcome reporting
CTRP Monthly Summary of Submissions





  250                                                                                         Amendments




        Jan Feb Mar Apr May Jun   Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun   Jul Aug
        '09 '09 '09 '09 '09 '09   '09 '09 '09 '09 '09 '09 '10 '10 '10 '10 '10 '10   '10 '10
Clinical Trials Reporting Office (CTRO)
Summary Metrics
• Metrics January 2009 to September 2010
  -   Original Submissions        2776
  -   Accepted                    2512
  -   Abstracted                  2520
  -   QC                          1096
  -   Trial Summary Report Sent   834
       • Abstraction Verified     234
  - Submitted amendments          136
CTRO – Sample statistics
• 2,515 trials submitted
   • 1,653 Proprietary submissions
   • 862 Non-proprietary submissions
• 2,173 Trials abstracted
   • 1,404 – proprietary
   • 769 – non-proprietary
   Over 50 trials on hold, 171 rejected
• 697 Trials with TSR/XML sent
   • 126 – proprietary
   • 571 – non-proprietary
• 206 Trials that sites have provided feedback on
   • 7% response rate for proprietary
   • 25% response rate for non-proprietary
CTRO – Processing Time

• Validation performed same day as receipt
• Abstraction – within 10 business days
   • After a complete submission is received
   • During periods of higher volume, CTRO may prioritize
     work flow
• Prioritization of work
   • Non-proprietary w/o NCTID
   • Non-proprietary w/NCTID
   • Proprietary trials
• Amendments – within 3 business days
CTRO – Notes and Requests

• Our source of truth is the protocol document
   • Title, ID, and investigator verifications
• Changes to protocol content require an official, IRB
  approved amendment
   • Amendments and TSR feedback
• Amendments require a change memo/summary
   • Clean copy of protocol

For questions about CTRO, rush requests and
  clarifications – contact
Feedback venues
 • National Cancer Advisory Board
    • Determined need for CTRP
    • High level monitoring of CTWG initiatives
 • Clinical and Translational Research Advisory
   Committee (CTAC)
    • Advisory Committee on deployment of CTWG
      initiatives; meets quarterly
 • caBIG® Clinical Trials Management Systems Steering
    • CTRP Strategic Subcommittee: conference calls bi-
      weekly on deployment strategy, reporting capability
 • Site calls
    • Conference calls on operational issues
Key Issues
• Restructuring Person and Organization NCI
  Enterprise Services to model complex organization
  hierarchies and relationships
• Batch and service specifications for Accruals and
• Information security specifications
• Summary 4 Funding (National, Peer-Reviewed,
  Institutional, Industrial) to replace proprietary/non-
  proprietary designated
• Meetings with NLM to align reporting between CTRP
• Improve communications to expand CTRP reporting
  of all NCI Supported Clinical Trials
CTRP User Resources
• Trial registration website:
• CTRP informational website:
   • Resources include FAQs, Glossary, and a CTRP User’s Guide
• CTRP Forum: https://cabig-
• – CTRP Users Listserv
• – Program questions
• – Clinical Trials Reporting

To top