The Committee’s Charge

The Protocol Review and Monitoring Committee (PRMC) is responsible for the scientific review of oncology-related interventional clinical research trials at Holden.

The PRMC reviews new interventional protocols and determines the prioritization of research participants to competing protocols. Each protocol undergoes review by two scientific members, a pharmacist, a statistician, and a patient advocate (as available). The committee continually monitors scientific progress and accrual for all ongoing studies under its purview.

The presence of the PRMC is indispensable for several reasons:

  1. Achieves NCI Designation: A Protocol Review and Monitoring System (PRMS) and PRMC are required components for Holden to be recognized as a comprehensive cancer center by the NCI. Such a designation acknowledges that Holden provides Iowans with access to a range of cancer treatment opportunities that few other U.S. cancer centers can offer, including a vast array of clinical trials and some of the newest therapies.
  2. Rigorous Internal Oversight: The committee performs rigorous internal oversight of the scientific aspects of oncology clinical studies, resulting in high-quality work.
  3. Expertise: PRMC members have scientific expertise from basic laboratory, clinical, prevention, cancer control, and population-based science. The committee evaluates new protocols and provides continuous monitoring of open protocols for scientific progress and accrual to ensure the aims of a study can be completed.
  4. Safety Evaluation: The PRMC evaluates new safety information that might significantly alter the scientific merit of the protocol. The committee also has the authority to close trials to accrual if necessary.
  5. Resource Allocation: The PRMC also assesses the feasibility and priority of proposed trials, helping to allocate resources effectively.

The Committee’s Make Up

Michael Goodheart, MD

Michael Goodheart, MD

PRMC Chair

Clinical Professor, Obstetrics and Gynecology
Ph: 1-319-356-2015
michael-goodheart@uiowa.edu

C. Michael Knudson, MD, PhD

C. Michael Knudson, MD, PhD

PRMC Co-Chair

Clinical Professor, Transfusion Medicine
Director, Tissue Procurement Core
Ph: 1-319-467-5129
c-knudson@uiowa.edu

Cena Jones-Bitterman, MPP, CIP, CCRP

Cena Jones-Bitterman, MPP, CIP, CCRP

Assistant Director, Compliance and Informatics

1-319-353-4596
cena-jones@uiowa.edu

Angela Childs, BA, CCRP

Angela Childs, BA, CCRP

PRMS Supervisor

Ph: 1-319-353-4595
angela-childs@uiowa.edu

Dagem Adera, BS

Dagem Adera, BS

PRMS Coordinator

Ph: 1-319-467-5742
dagem-adera@uiowa.edu

Brian Smith, PhD

Brian Smith, PhD

PRMC Biostatistician

Professor, Biostatistics
Phone: 1-319-384-1587
brian-j-smith@uiowa.edu

Gideon Zamba, PhD

Gideon Zamba, PhD

PRMC Biostatistician

Professor, Biostatistics
Phone: 1-319-384-1586
gideon-zamba@uiowa.edu

PRMC Members

Scientific Reviewers

  • Natalie L. Denburg, PhD, Professor, Neurology and Neuroscience
  • Prajwal Dhakal, MBBS, Clinical Assistant Professor, Internal Medicine, Hematology, Oncology, and Stem Cell Transplant and Cellular Therapy Program
  • Adam Dupuy, PhD, Professor, Anatomy and Cell Biology
  • Jenna Gedminas, MD, Clinical Assistant Professor, Division of Pediatric Hematology/Oncology and Stem Cell Transplantation
  • Jordan Harrelson, MA, Clinical Trials Research Specialist, Cancer Center
  • Nada Ibrahim, BS, Clinical Trials Research Associate, Cancer Center
  • Ashutosh Mangalam, PhD, Professor, Pathology
  • Sneha Phadke, DO, Clinical Associate Professor, Internal Medicine, Hematology, Oncology, and Stem Cell Transplant and Cellular Therapy Program
  • Hira Shaikh, MBBS, Clinical Assistant Professor, Internal Medicine, Hematology, Oncology, and Stem Cell Transplant and Cellular Therapy Program
  • Christopher Stipp, PhD, Professor Biology and Molecular Physiology and Biophysics
  • Nanmeng Yu, MD, PhD, Clinical Assistant Professor, Internal Medicine, Hematology, Oncology, and Stem Cell Transplant and Cellular Therapy Program
  • Praveen Vikas, MBBS, Clinical Associate Professor, Internal Medicine, Hematology, Oncology, and Stem Cell Transplant and Cellular Therapy Program

Pharmacy and Therapeutics Reviewers

  • Elizabeth Amelon, PharmD, Clinical Pharmacy Specialist, College of Pharmacy
  • Shannon Bailey, PharmD, Clinical Pharmacy Specialist, College of Pharmacy
  • Jason Cleppe, PharmD, Clinical Pharmacy Specialist, College of Pharmacy
  • Susan Fajardo, PharmD, Clinical Pharmacy Specialist, College of Pharmacy
  • Katie Gaspar, PharmD, Clinical Pharmacy Specialist, College of Pharmacy
  • Jonathan Lochner, PharmD, Clinical Pharmacy Specialist, College of Pharmacy
  • Carolyn Luedtke, PharmD, Clinical Pharmacy Specialist, College of Pharmacy
  • Samantha Meyer, PharmD, Clinical Pharmacy Specialist, College of Pharmacy
  • Ethan Sabers, PharmD, Clinical Pharmacy Specialist, College of Pharmacy
  • Marie Shinkle, PharmD, Clinical Pharmacy Specialist, College of Pharmacy
  • Emily Vahary, PharmD, Clinical Pharmacy Specialist, College of Pharmacy
  • Brandon Vakiner, PharmD, Clinical Pharmacy Specialist, College of Pharmacy

Biostatistics Reviewers

  • Brian J. Smith, PhD, Professor, Biostatistics
  • Gideon J. Zamba, PhD, Professor, Biostatistics

PRMC Administration

  • Cena Jones-Bitterman, MPP, CIP, CCRP, Assistant Director, Compliance and Informatics
  • Angela Childs, BA, CCRP, PRMS Supervisor
  • Dagem Adera, BS, PRMS Coordinator

Patient Advocates

  • Jane Fleming
  • Bridget Toomey, MS, CPC, CPPM, Director Clinical Services, Department of Obstetrics & Gynecology