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Clinical Research Committees

Clinical Research Committees

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.

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