caBIG CTMS Workspace F2F

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caBIG CTMS Workspace F2F San Francisco, August
29-30, 2005 CTWG Report Restructuring the
National Cancer Clinical Trials Enterprise John
Speakman
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National Cancer Advisory Board

• NCAB Advises DHHS Secretary and NCI Director
  with respect to the activities of the Institute
• The Clinical Trials Working Group (CTWG) was set
  up to advise the NCAB on the development,
  conduct, infrastructure, and support necessary
  for the optimal coordination and future progress
  of the entire range of intramural and extramural
  clinical research trials supported by the
  National Cancer Institute, including diagnosis,
  treatment, and prevention studies
• Initial meeting January 2004
• Final report published June 2005

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Clinical Trials Working Group Membership

• James H. Doroshow, M.D., Chair Richard S.
  Kaplan, M.D.
• Howard Fine, M.D., Co-Chair Michael S. Katz
• Maureen R. Johnson, Ph.D., Executive Director Amy
  S. Langer, M.B.A.
• James L. Abbruzzese, M.D.1 Gershon Y. Locker,
  M.D.
• Martin Abeloff, M.D. Eberhard A. Mack, M.D.
• Jeffrey S. Abrams, M.D. Lori Minasian, M.D.
• Peter Adamson, M.D.1 John E. Niederhuber, M.D.
• David Alberts, M.D.1 Rose Mary Padberg, R.N.,
  M.A.
• Karen Antman, M.D. David R. Parkinson, M.D.1
• Frederick R. Appelbaum, M.D.1 Richard Pazdur,
  M.D.1
• Steven D. Averbuch, M.D.1 Edith A. Perez, M.D.
• Peter Bach, M.D., M.A.P.P. Mark J. Ratain,
  M.D.1
• Colin Begg, Ph.D. Mack Roach, III, M.D.
• Kenneth H. Buetow, Ph.D. Julia H. Rowland,
  Ph.D.
• Michaele C. Christian, M.D. Richard Schilsky,
  M.D.1
• Jean B. DeKernion, M.D. Mitchell Schnall, M.D.,
  Ph.D.
• Leslie G. Ford, M.D. Daniel Sullivan, M.D.
• Louise B. Grochow, M.D. Sheila E. Taube, Ph.D.
• Ernest Hawk, M.D., M.P.H. James A. Zweibel,
  M.D.

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CTWG Summary Vision

• Enhance the best of all the components of the
  NCI-supported clinical trials system to develop a
  cooperative enterprise built on a strong
  scientific infrastructure and a broadly engaged
  coalition of critical stakeholders
• Note The next working group (on translational
  research) is already being formed

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Rationale for Change

• Advances in cancer biology offer enormous
  potential to improve cancer clinical practice
• Opportunity to move beyond cytotoxic treatments
  to more effective therapies targeting the
  specific characteristics of a patients tumor
• Challenge of evaluating an ever-increasing
  number of new, highly specific agents in
  molecularly-defined subsets of patients

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Common Themes

• Coordination
• Data sharing, incentives for team players
• Prioritization/Scientific Quality
• Involve all stakeholders
• Standardization
• IT infrastructure and clinical research tools
• Operational Efficiency
• improved cost-effectiveness and accrual rates,
  faster trial initiation
• Integrated Management
• Restructure oversight of NCI clinical trials

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Implementation Timeline

• The CTWG report comprises 22 initiatives
  organized by these five common themes
• The majority of initiatives are to be implemented
  by end of year 3
• Implementation is projected to be complete in 4-5
  years
• Recommendations are to be established as routine
  practice by end of year 7
• Year 1 begins October 2005

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1 Coordination Initiative

• Establish a comprehensive Clinical Trials
  Database to hold
• Descriptive information on trial status
• Clinical trial results
• Links to published or presented data
• Developed in concert with caBIG, overseen by
  NCICB
• Cancer Center submission to the system will be
  routine within three years (i.e., by Sept. 2008)

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The Clinical Trials Database

• Short term goal include data on all NCI
  sponsored trials, whatever the sponsorship
  mechanisms (CTEP, co-op groups, etc.)
• Long term goal include information on other
  trials (in-house-funded investigator-initiated,
  pharma sponsored, DoD sponsored, etc.)
• Once it is implemented, NCI will not invest
  resources in duplicative data repositories.

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Quotes from the report

• Data are currently collected by several
  different administrative units within the NCI.
  However, the specific data content and its format
  varies widely between these units. It is
  therefore not possible to electronically share
  data between NCI divisions, nor is it possible to
  provide electronically accessible data, even in
  anonymized, summary form, to the research
  community. Finally, none of the current NCI
  clinical trials databases reflect up-to-date
  principles of information systems design. They
  are not based on the structured data,
  standardized interfaces and modular architecture
  that would facilitate utilization across the
  entire cancer clinical trials enterprise. The
  infrastructure provided by the NCIs cancer
  Bioinformatics Grid (caBIG) is founded on these
  principles and can serve as a blueprint for the
  construction of the recommended database

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More quotes from the report

• NCI will establish a timeline for harmonizing
  all internal NCI IT systems with caBIG
  standards. The caBIG management team will work
  with Cooperative Groups, SPOREs, Cancer Centers,
  etc., to determine the approach, timeline, and
  resources necessary for either adopting the caBIG
  IT systems, or making current IT systems
  interoperable with caBIG. caBIG will also assist
  in providing resources necessary for effecting
  caBIG interoperability. NCI will require that all
  sites conducting NCI-supported clinical trials
  outside the CTSU provide, by a to-be-determined
  deadline, a plan to become caBIG-compatible. NCI
  award guidelines will be modified to require a
  plan for moving to caBIG interoperability, and
  new RFAs/RFPs requiring informatics support will
  be reviewed for caBIG compatibility

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Reading between the lines a bit

• We can assume that this new submission
  requirement by September 2008 will be instead
  of rather than as well as reporting to CDUS,
  CTMS, AdEERS, etc.
• Submission, not reporting if the NCI has all
  this data, they could presumably build their own
  Summary 3 and 4 reports, according to their
  current preferred format, instead of having
  cancer centers assemble them
• Potential extensions to CRIX have already been
  identified that will support this data CRIX
  would seem to be a natural home for the data
  repository that the CTWG report is advocating

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Standardization Initiatives

• Create Standard Clinical Research Tools
• Establish national cancer clinical trials IT
  infrastructure explicitly the standards, and
  the standards-based tools, that this caBIG
  Workspace will produce
• The long-term goal is for all clinical trial
  sites either to migrate to the caBIG architecture
  or to develop interfaces and other required
  enhancements such that their IT architecture is
  fully interoperable with the caBIG
  standards-based architecture
• Increase Clinical Investigator Input into caBIG
  Development
• Membership in caBIGs Clinical Trials Management
  System Workspace will be expanded to include
  additional clinical investigators from Cancer
  Centers, Cooperative Groups, CCOPs, SPORES, P01s,
  etc.

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Standardization Initiatives

• In consultation with industry and FDA, develop
  standard Case Report Forms incorporating Common
  Data Elements
• Accessible through caBIG for unrestricted use
• Build a credentialing system for investigators
  and sites recognized by NCI and industry.
• Likely to be built on the Firebird e-1572 part of
  CRIX already in pilot in some centers

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Determinants of Success

• Number of clinical trial management modules
  implemented in caBIG. Evaluation at 1 and 3
  years.
• The extent to which the caBIG standards and tools
  have been implemented in the cancer clinical
  trials community. Evaluation at 2 and 5 years.
• The number of caBIG compliant systems developed
  by vendors to service the cancer clinical trials
  community. Evaluation at 2 and 5 years.
• Level of caBIG interoperability of IT systems for
  clinical trial management throughout the broad
  oncology community. Evaluation at 2 and 5 years.
• Perception of clinical investigators of the
  utility of caBIG in mounting and managing a
  clinical trial. Evaluation at 2 and 5 years.
• Cost and time savings achieved through IT
  interoperability. Evaluation at 5 and 7 years.

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Other initiatives include

• Realign NCI reward system and academic incentives
  to encourage investigator collaboration
• Enhance coordination with Federal agencies
  (especially FDA and CMS)
• Expand awareness of the NCI-FDA expedited
  approval process to speed trial initiation
• Work with CMS to identify clinical studies that
  address both NCI and CMS objectives

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Estimated Implementation Budget (M)
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Conclusions

• Commitment of 7m to CTWG in FY06 6/27/05 NCI BSA
  meeting
• caBIG is clearly front and center
• A wake-up call not just for cancer centers
• caBIG is not going to go away
• but also for caBIG
• There needs to be a greater emphasis on clinical
  trials within caBIG

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Presidents Cancer Panel

• Reports annually to the President
• Goal Appraise the National Cancer Program
• 2005 report identified research resource needs
• interoperable bioinformatics systems with
  standardized formats and datasets
• coordinated, linked biorepositories with
  standardized information on specimens
• an improved mechanism to enable FDA to share
  clinical trials information with the academic
  community

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Presidents Cancer Panel (contd.)

• The report notes the lack of an academic base
  to the conduct of clinical trials
• Given its importance to peoples health and its
  economic impact, the lack of technological focus
  on product development is actually astounding
  regulatory official quoted in PCP report
• This is where BRIDG, and the Best Practices SIG,
  can help

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Thats it!

• Clinical Trials Working Group
• http//integratedtrials.nci.nih.gov/
• Presidents Cancer Panel
• http//deainfo.nci.nih.gov/advisory/pcp/pcp.htm
• Questions?
• Implementation of CTWG Sue Dubman