HUNTSMAN CANCER INSTITUTE

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HUNTSMAN CANCER INSTITUTE

• Jennifer Katz, CCRP
• Administrative Director of Clinical Research
• 585-5017
• Jennifer.Katz_at_hci.utah.edu

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Protocol Review and Monitoring System (PRMS)

• Clinical Cancer Investigations Committee (CCIC)
• Data and Safety Monitoring Committee (DSMC)
• Data and Quality Subcommittee (DQS)
• Endpoint Review Subcommittee (ERS)

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Clinical Cancer Investigations Committee- CCIC -

• Why and what is CCIC?
• Who is CCIC?
• What do they do?

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Why CCIC?

• NCI mandated as part of our Cancer Center
  designation
• Meet the 4th Thursday of each month

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Who is the committee

• David Gaffney, M.D., Ph.D Chair (Rad/Onc)
• Leigh Neumayer, M.D. Co-chair (Surgery)
• Wally Akerley M.D. (Oncology)
• Philip Bernard M.D., Ph.D. (Pathology)
• D. Dean Billheimer, Ph.D. (Biostats)
• Ken Boucher, Ph.D. (Biostats)
• Michael Glantz, M.D. (Neuro/Oncology)
• Karen Heichman, Ph.D. (Basic Science)
• John Hoffman, M.D. (Nuclear Medicine Imaging)

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• Melissa Johnson, Pharm.D. (Investigational
  Pharmacy)
• Richard Kerber, Ph.D. (Onc/Pop Sciences)
• Steven Kirkegaard, Pharm D. (Pharmacy)
• Sherrie Perkins, M.D., Ph.D. (Path/Pediatrics)
• Michael Pulsipher, M.D. (Hemaology- BMT
  Adult/Peds)
• Courtney Scaife, M,D. (Surgery)
• Ben Tanner Dir of Clinic operations HCH
• (Patient Advocate)
• Kathi Mooney, R.N., Ph.D (Ad Hoc Nursing)

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Committee Objectives

• Scientific merit review for all cancer-related
  research done at the University of Utah
• Coordination with other approved cancer protocols
• Resource utilization within CTO
• Review and approval of amendments
• Accrual and progress review annually

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Documents reviewed

• Protocol
• Protocol summary
• Consent (full review on investigator initiated
  protocols)
• IRB/CCIC applications
• Investigator Brochures (where applicable)
• Questionnaires, patient diaries

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Reviewer checklist

• Hypothesis clearly stated
• Adequate background
• Importance of science
• Methods developed, well-integrated and
  appropriate to aims
• Eligibility criteria clear and appropriate
• 1st and 2nd endpoints, response toxicity eval
  criteria defined
• Is study feasible
• Statistical methods sound

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Reviewer checklist cont.

• Sample size appropriate
• Stopping rules
• Dosing and dose modifications clear
• Drug information complete and accurate
• Safety issues
• Accrual goal attainable
• Compete with other protocols
• MDG support and priority
• Overall evaluation

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Committee Recommendations

• Approve
• Defer with administrative review prior to
  approval
• Defer with full board review prior to approval
• Disapprove

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ERICA/CCIC bridge
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• CCIC now linked electronically to ERICA
• Review comments available to IRB reviewer
• Investigator initiated projects approved by CCIC
  prior to IRB review
• Industrial Cooperative Group receive
  simultaneous review

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Questions