HUNTSMAN CANCER INSTITUTE

Jennifer Katz, CCRPAdministrative Director of Clinical Research

585-5017Jennifer.Katz@hci.utah.edu

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