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HUNTSMAN CANCER INSTITUTE
Jennifer Katz, CCRPAdministrative Director of Clinical Research
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)
Clinical Cancer Investigations Committee
- CCIC -
Why and what is CCIC?
Who is CCIC?
What do they do?
Why CCIC?
NCI mandated as part of our Cancer Center designation
Meet the 4th Thursday of each month
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)
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)
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 CTOReview and approval of amendmentsAccrual and progress review annually
Documents reviewed
ProtocolProtocol summaryConsent (full review on
investigator initiated protocols)IRB/CCIC applicationsInvestigator Brochures (where
applicable)Questionnaires, patient diaries
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
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
Committee Recommendations
ApproveDefer with administrative review
prior to approvalDefer with full board review prior
to approvalDisapprove
ERICA/CCIC bridge
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
Questions
