Before a clinical trial begins, there is an extensive review process to determine scientific merit and patient safety. Below is a list of committees that evaluate clinical trials before they open at Huntsman Cancer Institute (HCI).

Clinical Research Executive Committee

The Clinical Research Executive Committee (CREC), comprised of senior clinical research leaders at HCI, oversees and directs clinical research at HCI, including policy setting for the Clinical Cancer Investigations Committee (CCIC) and Data Safety Monitoring Committee (DSMC). It also establishes priorities for the Clinical Trials Office (CTO), reviews general accrual and resource allocation issues, and facilitates integration of research into the HCI multidisciplinary clinics. This committee reviews minority recruitment efforts and assists in the development of future plans to enhance patient accrual.

CREC Members:

• Sunil Sharma, MD, Chair 
  Senior Director of Clinical Research
  Jon and Karen Huntsman Presidential Professor in Cancer Research 
  Professor, Department of Internal Medicine
• Wallace Akerley, MD, DSMC 
  Senior Director of Community Oncology Research, HCI 
  Chair, Data and Safety Monitoring Committee 
  Professor, Department of Internal Medicine
• *Brad Bott, MBA, CCRP, Ad hoc
  Director, Clinical Trials Operations
• Donna Branson, BS, Minority Outreach
  Director, Patient and Public Education and Outreach
• Michael Deininger, MD, PhD, Faculty representative (1 year term Nov 2011)
  Chief, Division of Hematology and Hematologic Malignancies
  Professor of Medicine
• David Gaffney, MD, PhD, CCIC (sabbatical: Dec 2011-Sept 2012)
  Chair, Clinical Cancer Investigations Committee
  Professor, Department of Radiation Oncology
• Sheri Holmen, PhD - MDG representative (1 year term Nov 2011)
  Associate Professor
  Department of Surgery
• *Jennifer Katz, BS, CCRP, Ad hoc
  Director of Research Compliance and Oversight
• Richard Lemons, MD, PhD, Pediatric representative
  Professor, Department of Pediatrics 
  Chief, Pediatric Hematology/Oncology 
  Primary Children’s Medical Center
• Scott Lloyd, MBA, CPA, Finance and Administration
  Senior Director, Finance and Administration
• Leigh Neumayer, MD interim CCIC representative
  Acting Chair, Clinical Cancer Investigations Committee
  Professor, Department of Surgery
• *Ellen Wilson, PhD – Ad hoc
  Senior Scientific Writer and Project Manager

* Non-voting members

Protocol Review Monitoring System

The Clinical Cancer Investigations Committee (CCIC) was established to provide scientific review for all cancer trials as required by National Cancer Institute (NCI) Cancer Center Support Grant (CCSG) guidelines. All clinical trials at the University of Utah that involve cancer patients or subjects at risk for cancer (screening or prevention studies) must undergo an initial review by the CCIC. Two reviewers with no involvement in the trial under review, a biostatistician, a research pharmacist, a research nurse, and a patient advocate provide written reviews.

CCIC Members:

• David Gaffney, MD, PhD, Chair
  Professor
  Radiation Oncology 
• Leigh Neumayer, MD, Interim Chair
  Professor of Surgery
• Michael A Pulsipher, MD, Interim Vice Chair
  Associate Professor of Internal Medicine (Hematology)
• Neeraj Agarwal, MD
  Assistant Professor
• Kenneth M Boucher, PhD 
  Research Associate Professor (Biostats)
  Oncological Sciences
• Lisa Cannon-Albright, PhD
  Biomedical Informatics
• Adam Cohen
  Instructor of Internal Medicine (Breast, Neuro-oncology)
• Howard Colman, PhD 
  Neurosurgery
• Jennifer Demko, RN, BSN, OCN
  Research Nurse, (Nursing)
• Tom Greene, PhD
  Professor (Clinical Epidemiology)
  Department of Internal Medicine
• Karen A Heichman, PhD
  Director/ARUP
• Elke A. Jarboe, MD
  Assistant Professor
• Rian Davis, Pharm D
  Graduate Research Assistant
  College of Pharmacy
• Paul Shami, MD
  Hematology
• Sadie Quinn
  (Patient Advocate)
• David Stenehjem, PharmD
  Research Assistant Professor
• Sunil Sharma, MD, FACP
  Senior Director of Clinical Research
  Professor of Internal Medicine (Oncology)

Ad Hoc Reviewers:

• Saundra Buys, MD
• Kathi Mooney, RN, PhD
• Margaret Clayton, PhD APRN-BC
• Brad Cairns
• David Jones

Data and Safety Monitoring Committee

The Data and Safety Monitoring Committee (DSMC) was established by HCI in response to NCI and NIH requirements. Data and safety monitoring functions are separate and distinct from the study review and approval performed by the Institutional Review Board (IRB) and the scientific review conducted by the CCIC.

DSMC members:

• Wallace Akerley, MD, Chair
  Professor of Medicine
  Senior Director of Community Oncology Research
  Medical Director, Clinical Trials Office
• William Dunson, MD, Vice Chair 
  Assistant Professor 
  Medical Director, HCH Outpatient Clinics 
  Medical Director, Internal Medicine Acute Care Clinic
• Zeinab Afify, MD 
  Associate Professor 
  Pediatric Hematology/Oncology
• Nan Hu, PhD
  Assistant Professor
  Cancer Control and Population Sciences
• Dennis Shrieve, MD 
  Professor
  Department Chair, Radiation Oncology
• Maurizio Zangari, MD 
  Professor, Director
  Hematology Oncology
• Lori Blackburn*
  Administrative Assistant
  Clinical Research Compliance
• Heather Cronin, MSC* 
  Research Compliance Officer
  Clinical Research Compliance
• Jennifer Katz, BS, CCRP*
  Director of Research Compliance and Oversight
  Clinical Research Compliance
• Adriann Kern, CCRP*
  Research Compliance Officer
  Clinical Research Compliance
• Scott Low, BS, MBA, CCRP*
  Research Compliance Officer
  Clinical Research Compliance
• Shanon Matkin, CCRP*
  Research Compliance Officer
  Clinical Research Compliance
• Kelli Thorne, MPH*
  Research Compliance Officer
  Clinical Research Compliance

* non-voting member

Two subcommittees of the DSMC were established to monitor study and data integrity:

Data Quality Subcommittee - The Data Quality Subcommittee (DQS) is responsible for performing full audits of all HCI-originated studies and any other active clinical trials not externally audited. Audits include review of eligibility, protocol compliance, toxicity grading, adverse event reporting, data quality, consent process, other regulatory compliance, and pharmacy compliance. Audits are routinely performed following accrual of the third patient to the study and then annually. More frequent audits can be mandated if serious concerns arise during planned audits. Audit results are reported to the DSMC, the IRB, and the PI. If closure is recommended or a project amendment results from the audit findings, the CCIC is notified.

Endpoint Review Subcommittee - The Endpoint Review Subcommittee (ERS) is responsible for reviewing and certifying responses, survival, or other major study endpoints for all HCI-originated studies. Protocol endpoints are reviewed at times specified by early stopping rules and at completion of the study. Subcommittee review is required prior to publication. Results are reported to the DSMC, the CCIC, and the PI, and are incorporated into the research record.