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Protocol Review Committee

The mission of the Yale Cancer Center (YCC) Protocol Review Committee (PRC), YCC’s Protocol Review and Monitoring System (PRMS), is to provide ongoing review of scientific merit, priorities, and progress of YCC clinical trials. The PRMS has the authority to open protocols that meet the scientific merit and scientific priorities of the YCC and to close protocols that do not demonstrate scientific progress.

Protocol Review

The YCC PRC is charged with the scientific evaluation of all cancer and cancer-related clinical trials proposed at Yale prior to initiation. The PRC reviews a sub-set of amendments for cancer and cancer-related clinical trials. PRC protocol review encompasses an assessment of the scientific rationale and merit of a proposed study or amendment in addition to review of protocol design, safety parameters, prioritization and a biostatistical analysis to determine that high quality and appropriate designs have been incorporated.

The PRC functions to approve and provide oversight for protocols submitted by each of the Disease Aligned Research Teams (DART), which serves as the first stage for review of proposed protocols and select clinical trials according to their scientific merit and strategic DART portfolio fit. When combined, the DART protocol review and PRC review processes synergistically ensure that all proposed clinical trials receive high-quality peer review and monitoring, remain consistent with YCC clinical research priorities, and progress in a timely fashion.
In addition:

  • The PRC assigns a priority score that considers scientific merit and other available studies and is based upon an averaged points system.
  • The PRC assigns a Data and Safety Monitoring Plan (DSMP). This plan consists of an internal audit schedule and a timeline for the PI to submit data and safety monitoring reports for review to the YCC Data and Safety Monitoring Committee (DSMC). The DSMP considers the quality assurance risk level of the study based upon a risk assessment score sheet.

Refer to Guidelines for Submissions for more information on submitting protocol reviews to PRC.

Accrual Monitoring

PRC monitors accrual of open to enrollment, interventional, cancer and cancer-related clinical trials, except for trials of rare diseases or rare molecular sub-types, monthly. Accrual targets and screening efforts for trials of rare diseases and rare molecular sub-types are assessed during scientific progress reviews. DARTs must enter accrual targets for trials with dose escalation and dose expansion phases in OnCore according to the Protocol Review Committee OnCore Instructions for Dose Escalation/ Dose Expansion Studies to ensure PRC can accurately monitor the accrual.

Clinical trials that do not meet accrual targets will receive written notification from the PRC. The Accrual Monitoring Policy (See Important Documents section below) details the assessment timepoints, percentage of target accrual rate expected and the associated action. Notices, warning letters and closure recommendations will be distributed for clinical trials with no or low accrual. The Principal Investigator (PI) and/ or DART Leader is expected to respond to closure recommendations via submission of a Closure Review to PRC. The PRC will vote to close or not close studies recommended for closure. The PI and DART Leader will be informed of the PRC’s determination.

Refer to Guidelines for Submissions for more information on submitting closure reviews to PRC.

Scientific Progress

PRC reviews scientific progress for active (open to accrual and temporarily suspended) interventional cancer and cancer-related clinical trials annually. Trials that are no longer scientifically relevant or that will not meet their scientific objective(s) may be closed to further accrual.

Committee Chairs

PRC I

  • Chair

    Associate Professor of Internal Medicine (Hematology); Director, Early Therapeutics Research, Hematology; Leader, Disease Aligned Research Team (DART) for Leukemias and Myeloid Malignancies, Yale Cancer Center; Chair, Protocol Review Committee (PRC) I, Yale Cancer Center; Assistant Medical Director, Clinical Trials Office (CTO), Yale Cancer Center

    Amer Zeidan, MBBS, MHS @Dr_AmerZeidan is an Associate Professor of Medicine (Hematology) at Yale University. He is also the medical director of Hematology Early Therapeutics Research, the leader of the Myeloid malignancies DART (Disease Aligned Research Team), and the director of Continuing Medical Education (CME) at the Hematology division at Yale Cancer Center. Dr. Zeidan completed a hematology/oncology fellowship and a clinical research fellowship in myelodysplastic syndromes (MDS) at Johns Hopkins University where he also earned a Master of Health Science (MHS) degree in Clinical Investigation. Dr. Zeidan specializes in the management of myeloid malignancies especially MDS and acute myeloid leukemia (AML).The focus of Dr. Zeidan’s clinical/translational research is the development of novel therapies for myeloid malignancies, with a special focus on targeted therapies and immunotherapy-based approaches. Dr. Zeidan is also active in health outcomes and comparative effectiveness research for blood cancers and their therapies. Dr. Zeidan has and continues to serve as the principal investigator of many investigator-initiated, cooperative group and industry sponsored clinical trials for myeloid malignancies. Dr Zeidan also chairs or serves on the steering committees of several large clinical trials of myeloid malignancies. He has served as the vice chair of the Yale Cancer Center Data and Safety Monitoring Committee (YCC DSMC) and currently serves in the independent data and safety monitoring committees of multiple clinical trials. Dr. Zeidan is a member of the MyeloMATCH Precision medicine initiative of the National Cancer Institute (NCI) for both MDS and AML and is very active within the Cancer Therapy Evaluation Program (CTEP) and Early Therapy Clinical Trial Network (ETCTN) in working on early phase clinical trials of novel therapies for myeloid malignancies. Dr. Zeidan has presented his research in many meetings and has been an invited speaker nationally and internationally. He regularly reviews abstracts for the American Society of Hematology (ASH) annual meetings and chairs meeting sessions. He has been presented on MDS in the ASH Annual highlights meetings in USA and Asia-Pacific as well as the ASH Meeting on Hematologic Malignancies. He is also active within the International Working Group (IWG) of MDS and has previously served on the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines panel for MDS. Dr. Zeidan has received several prestigious awards including the Leukemia and Lymphoma Society Scholar in Clinical Research award, the National Cancer Institute Cancer Clinical Investigator Team Leadership award, the AAMDSIF/Evan’s Foundation-MDS Clinical Research Consortium Fellowship award, the Tito Bastianello Young Investigator Award, the ASCO Young Investigator Award, and multiple other achievement awards. Dr. Zeidan also serves on the editorial board and is a reviewer of several important hematology and oncology journals. He is an author on more than 260 peer-reviewed publications and book chapters.
  • Vice Chair

    Associate Professor of Medicine (Medical Oncology); Disease Aligned Research Team (DART) Leader Sarcoma, Medical Oncology; Director Medical Oncology Inpatient Consult Service, Medical Oncology

    Dr. Hari Deshpande, Associate Professor of Medicine in the Section of Medical Oncology, cares for patients with sarcomas along with the sarcoma multidisciplinary team.Previously in practice at both the New London Cancer Center and Las Vegas Cancer Center, Dr. Deshpande also has clinical interests in sarcomas, cancers of unknown primary, and thyroid cancers. He is a member of the Head and Neck Cancer and GU cancer teams. He is the Director of the Medical Oncology Inpatient Consult service.Learn more about Dr. Deshpande>>

PRC II

  • Chair

    Professor of Neurology; Chief, Neuro-Oncology; Clinical Trials Director, Chenevert Family Brain Tumor Center at Smilow Cancer Hospital and Yale Cancer Center

    Dr. Omuro is the chief of the Division of Neuro-Oncology and Director of the Yale Brain Tumor Center. He is a graduate and former faculty of the Neuro-Oncology program at Memorial Sloan Kettering Cancer Center in New York. Dr. Omuro is an internationally renowned leader in clinical care and research in the field of brain tumors, having led pivotal research projects and clinical trials to advance the treatment of these difficult cancers.
  • Vice Chair

    Associate Professor of Internal Medicine (Medical Oncology); Director, Center for Gastrointestinal Cancers at Smilow Cancer Hospital and Yale Cancer Center; Chief, GI Medical Oncology; Vice Chief, Diversity, Equity, and Inclusion, Medical Oncology

    Dr. Kunz joins Yale from Stanford University School of Medicine where she was Director of the Stanford Neuroendocrine Tumor Program, Leader of the Endocrine Oncology Research Group, and Director of the Neuroendocrine Tumor Fellowship. Beyond her record of accomplishment in GI Oncology, Dr. Kunz is an international leader in the clinical care of patients with neuroendocrine tumors (NETs) and is advancing the field through clinical trials and translational science that are defining the next generation of therapies for patients with this rare diagnosis. Learn more about Dr. Kunz >>