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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 Protocol Review and Monitoring Committee (PRMC) 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
    Senior Director of Clinical Research, HCI
    Jon and Karen Huntsman Presidential Professor in Cancer Research
    Chief of Medical Oncology
    Professor, Department of Internal Medicine, Division of Oncology
  • John Sweetenham, MD – Co-Chair
    
Senior Director of Clinical Affairs, HCI
    
Executive Medical Director, Huntsman Cancer Hospital
    
Professor, Department of Internal Medicine, Division of Hematology/BMT
  • Wallace Akerley, MD - PRMS
    Senior Director of Community Oncology Research, HCI
    Professor, Department of Internal Medicine, Division of Oncology
  • Donna Branson, BS - Minority Outreach
    
Director, Patient and Public Education and Outreach, HCI
  • Michael B. Cohen, MD - Pathology Representative
    
Vice Chair for Faculty Development
    
Professor, Department of Pathology
    Associate Director, ARUP Laboratories R&D Institute
  • *Renae Hepler – Research Administration
    Director of Administration, HCI
  • John Hoffman, MD – Imaging Representative
    
Director, Nuclear Medicine and Molecular Imaging Program
    Professor, Department of Radiology, Division of Clinical Radiology
    Professor, Department of Neurology
  • Sheri Holmen, PhD - MDG/Basic Science Representative 
    
Associate Professor
, Department of Surgery
  • Jennifer Katz, BS, CCRP - Dean's Office Research Unit
    
Co-Chair, Data and Safety Monitoring Committee
    Director of Research Compliance, HCI
    Clinical Trials Compliance Advisor, Dean’s Office Research Unit
  • Richard Lemons, MD, PhD - Pediatric Research 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
  • Ana Maria Lopez, MD - Cancer Health Equity
    Director of Cancer Health Equity, Huntsman Cancer Institute
    Associate Vice President for Health Equity and Inclusion, University of Utah
  • Jessica Moehle, BS, CCRP
    Associate Director of Operations, Clinical Trials Office
  • Elizabeth Raetz, MD - DSMC
    Chair, Data and Safety Monitoring Committee
    Professor, Department of Pediatrics, Division of Hematology/Oncology
    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 Institute Hospital
  • Cornelia Ulrich, PhD, MS - Population Sciences
    Senior Director of Population Sciences, HCI
    Jon and Karen Huntsman Presidential Professor in Cancer Research
    Professor, Department of Oncological Sciences
  • Theresa Werner, MD - CTO Medical Director
    Medical Director, Clinical Trials Office
    Associate Director, HCI Phase 1 Clinical Trials Program
    Assistant Professor, Department of Internal Medicine, Division of Oncology
  • *Ellen Wilson, PhD – Ad hoc
    Senior Scientific Writer and Project Manager

* Non-voting member

Protocol Review and Monitoring System
Protocol Review and Monitoring Committee (PRMC)

The PRMC 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 PRMC. 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.

PRMC Members:

  • Wallace Akerley, MD, Chair
    Chair, Protocol Review and Monitoring Committee
    Professor, Department of Internal Medicine, Division of Oncology
  • Adam Cohen, MD, Vice-Chair
    Assistant Professor, Department of Internal Medicine, Division of Oncology
    Breast, Neuro-Oncology
  • Neeraj Agarwal, MD
    Assistant Professor, Department of Internal Medicine, Division of Oncology
  • Kylee Arbogast, RN BS, CCRP
    Clinical Nurse, Neuro-Oncology, HCI
  • Phillip E. Barnett, MD, DVM
    Pediatric Hematology-Oncology, Primary Children’s Medical Center
    Associate Professor, University of Utah School of Medicine
  • Kenneth M Boucher, PhD 
    Research Associate Professor (Biostatistics Representative)
    Department of Internal Medicine, Division of Epidemiology
  • Lisa Cannon-Albright, PhD
    Professor, Department of Internal Medicine, Division of Epidemiology
    Biomedical Informatics
  • Howard Colman, MD, PhD 
    Associate Professor, Department of Neurosurgery
    Neuro-oncology
  • Rian Davis, Pharm D, PhD
    Investigational Pharmacy, HCI
    College of Pharmacy
  • Sadie Gabler, CCRP
    Senior Research Coordinator, Department of Associate VP for Research Integrity
    Patient Advocate
  • Tom Greene, PhD
    Professor, Department of Internal Medicine, Division of Epidemiology
    Clinical Epidemiology
  • Randy Jensen, MD, PhD
    Professor, Departments of Neurosurgery, Radiation Oncology, Oncological Sciences, Division of Adult Neurosurgery
    Residency Program Director, Neurosurgery
  • Shane Lloyd, MD
    Assistant Professor, Department of Radiation Oncology
  • Rodney Miles, MD, PhD
    Assistant Professor, Department of Pathology
  • Paul Shami, MD
    Professor, Department of Internal Medicine, Division of Hematology and Hematologic Malignancies
  • David Stenehjem, PharmD
    Research Assistant Professor, Department Pharmacotherapy
  • John Sweetenham, MD
    Senior Director of Clinical Affairs, HCI
    Executive Medical Director, Huntsman Cancer Hospital
    Professor, Department of Internal Medicine, Division of Hematology/BMT
  • John Ward, MD
    Professor, Department of Internal Medicine, Division of Oncology

Ad Hoc Reviewers:

  • Saundra Buys, MD
    Interim Senior Director of Population Sciences
    Medical Director, High Risk Cancer Research
    Professor, Department of Internal Medicine, Division of Oncology
  • Margaret Clayton, PhD, APRN-BC
    Associate Professor, Department of Nursing, Division Acute and Chronic Care
  • Kathi Mooney, RN, PhD
    Professor, Department of Nursing, Division of Acute and Chronic Care
  • Sunil Sharma, MD, FACP
    Senior Director of Clinical Research, HCI
    Jon and Karen Huntsman Presidential Professor in Cancer Research
    Chief of Medical Oncology
    Professor, Department of Internal Medicine, Division of Oncology
  • Jeffrey Yap, PhD
    Associate Professor, Clinical Radiology
    Associate Director, Center for Quantitative Cancer Imaging

    Ex Officio Member
    Mary Beckerle, PhD
    Ralph E. and Willia T. Main Presidential Professor
    CEO and Director, Huntsman Cancer Institute
    Associate Vice President for Cancer Affairs, University of Utah

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 PRMC.

DSMC members:

  • Elizabeth Raetz, MD, Chair
    Chair, Data and Safety Monitoring Committee
    Professor, Department of Pediatrics, Division of Hematology/Oncology
    Medical Director, High Risk Leukemia and Lymphoma Program, Primary Children’s Hospital
  • Jennifer Katz, BS, CCRP, Dean's Office Research Unit
    Co-Chair, Data and Safety Monitoring Committee
    Director of Research Compliance, HCI
    Clinical Trials Compliance Advisor, Dean’s Office Research Unit
  • Zeinab Afify, MD 
    Associate Professor, Department of Pediatrics, Division of Pediatric Hematology/Oncology
  • G. Weldon Gilcrease III, MD
    Instructor of Medicine, Department of Internal Medicine, Division of Oncology
  • Martha Glenn, MD
    Associate Professor, Department of Internal Medicine, Division of Hematology and Hematologic Malignancies
  • Nan Hu, PhD
    Research Assistant Professor, Department of Internal Medicine, Division of Epidemiology
    Biostatistician
  • Gita Suneja, MD, MS
    Assistant Professor, School of Medicine, Department of Radiation Oncology
  • Theresa L. Werner, MD 
    Assistant Professor, Department of Internal Medicine, Division of Oncology
    Medical Director, Clinical Trials Office
  • *Ginger Bair - DSMC Secretary

* non-voting member