Clinical Trials at HCI

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 and 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 - Co-Chair 
    Chief of Medical Oncology
    
Senior Director of Clinical Research
    
Jon and Karen Huntsman Presidential Professor in Cancer Research 
    
Professor, Department of Internal Medicine
  • John Sweetenham, MD – Co-Chair
    
Senior Director of Clinical Affairs
    
Executive Medical Director, HCI
    
Professor, Department of Internal Medicine
  • *Chad Adams, MPH - CTO
    
Administrative Director, Clinical Trials Office
  • Wallace Akerley, MD - CTO Medical Director
    Senior Director of Community Oncology Research, HCI 
    
Chair, Data and Safety Monitoring Committee 
    
Professor, Department of Internal Medicine
  • Donna Branson, BS - Minority Outreach
    
Director, Patient and Public Education and Outreach
  • Michael B. Cohen, MD - Pathology Representative
    
Vice Chair for Faculty Development
    
Associate Director, ARUP Laboratories R&D Institute
    
Professor, Department of Pathology
  • Michael Deininger, MD, PhD - Faculty Representative 
    
Chief, Division of Hematology and Hematologic Malignancies
    
Professor of Medicine
  • David Gaffney, MD, PhD - CCIC
    
Chair, Clinical Cancer Investigations Committee
    
Professor, Department of Radiation Oncology
  • *Renae Hepler – Research Administration
    Administrative Director, Huntsman Cancer Institute
  • John Hoffman, MD – Imaging Representative
    
Director, Nuclear Medicine and Molecular Imaging Program
    
Professor of Radiology and Neurology
  • Sheri Holmen, PhD - MDG Representative 
    
Associate Professor
, Department of Surgery
  • Jennifer Katz, BS, CCRP - Clinical Trials Support Unit
    
Administrative Director, Clinical Trials Support Unit
    
Dean's Office, School of Medicine
  • Richard Lemons, MD, PhD - Pediatric Representative
    
Professor, Department of Pediatrics 
    
Chief, Pediatric Hematology/Oncology
    
Primary Children’s Hospital
  • Scott Lloyd, MBA, CPA - Finance and Administration
    
Senior Director, Finance and Administration
  • Elizabeth Raetz, MD - DSMC
    Professor, Department of Pediatrics
    Medical Director, High Risk Leukemia and Lymphoma Program
    Primary Children’s Hospital
  • *Teri Richards - CREC Secretary
  • Ben Tanner, MHA – Huntsman Cancer Hospital
    Director, Clinical Operations/Chief Operating Officer
    Huntsman Cancer Hospital
  • *Ellen Wilson, PhD – Ad hoc
    Senior Scientific Writer and Project Manager

* Non-voting member

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 of Radiation Oncology 
  • Leigh Neumayer, MD, Vice Chair
    Professor of Surgery
  • Michael A Pulsipher, MD
    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, MD
    Assistant Professor
    Breast, Neuro-oncology
  • Howard Colman, MD, PhD 
    Neurosurgery
  • Carol Higginson, BSN
    Research Nurse, (Nursing)
  • Tom Greene, PhD
    Professor (Clinical Epidemiology)
    Department of Internal Medicine
  • Karen A Heichman, PhD
    VP Director/ARUP
  • Elke A. Jarboe, MD
    Assistant Professor
  • Rian Davis, Pharm D, PhD
    College of Pharmacy
  • Paul Shami, MD
    Professor (Hematology)
  • Sadie Gabler
    (Patient Advocate)
  • David Stenehjem, PharmD
    Research Assistant Professor
  • John Sweetenham, MD
    Senior Director of Clinical Affairs
    Professor of Medicine
  • John Ward, MD
    Professor, Oncology

Ad Hoc Reviewers:

  • Saundra Buys, MD
  • Kathi Mooney, RN, PhD
  • Margaret Clayton, PhD APRN-BC
  • Alana Welm, PhD
  • Sunil Sharma, MD, FACP

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:

  • Elizabeth Raetz, MD, Chair
    Professor, Department of Pediatrics, Pediatric Hematology/Oncology
    Medical Director, High Risk Leukemia and Lymphoma Program, Primary Children’s Hospital
  • Jennifer Katz, BS, CCRP, Co-chair
    Director of Research Compliance and Oversight
    Clinical Research Compliance Office
  • Zeinab Afify, MD 
    Associate Professor, Department of Pediatrics, Pediatric Hematology/Oncology
  • Wallace Akerley, MD
    Professor, Department of Internal Medicine, Thoracic Cancer
    Senior Director of Community Oncology Research
    Medical Director, Clinical Trials Office
  • William Dunson, MD
    Assistant Professor, Division of General Internal Medicine
    Medical Director, HCI Outpatient Clinics 
    Director, Acute Care Clinic and Internal Medicine Service
  • Martha Glenn, MD
    Associate Professor, Division of Hematology and Hematologic Malignancies
  • Nan Hu, PhD
    Assistant Professor, Department of Internal Medicine, Department of Family and Preventive Medicine (Adjunct)
    Cancer Control and Population Sciences
  • Theresa L. Werner, MD 
    Assistant Professor, Division of Oncology, Department of Medicine
  • Ginger Bair*
    Administrative Program Coordinator
    Clinical Research Compliance Office
  • Scott Low, MBA, CCRP* 
    Manager, Research Compliance Office
    Clinical Research Compliance Office
  • Shanon Matkin, BS, CCRP*
    Research Compliance Officer
    Clinical Research Compliance Office
  • Debbie Pitt, BS, CCRP*
    Research Compliance Officer
    Clinical Research Compliance Office
  • Kelli Thorne, MPH, CCRP*
    Research Compliance Officer
    Clinical Research Compliance Office
  • Dholani Zarook, BS, CCRP*
    Research Compliance Officer
    Clinical Research Compliance Office

* non-voting member