Protocol Review Committee (PRC)

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 PRC functions to approve and provide oversight for protocols submitted by each Clinical Research Team (CRT), which serves as the first stage for review of proposed protocols and select clinical trials according to their scientific merit and strategic CRT portfolio fit. When combined, the CRT 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.

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. CRTs 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 CRT 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 CRT Leader will be informed of the PRC’s determination.

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.

Important Documents

PRC I Chair & Vice-Chair

Mario Sznol, MD
Chair
Professor of Medicine (Medical Oncology); Clinical Research Leader, Melanoma Program; Co-Leader, Cancer Immunology, Yale Cancer Center; Co-Director, Yale SPORE in Skin Cancer
Dr. Mario Sznol is a Professor of Medicine (Medical Oncology). Dr. Sznol, formerly with the National Cancer Institute, has an international reputation in cancer drug development. Dr. Sznol's expertise and experience is in cancer immunotherapy, drug development for cancer, and treatment of patients with melanoma and renal cell carcinoma. He is working to expand the opportunities for clinical trials at the Yale Cancer Center, particularly those focusing on immunotherapy and novel agents.Learn more about Dr. Mario Sznol>>
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Hari Deshpande, MD
Vice-Chair
Associate Professor of Medicine (Medical Oncology); Clinical Research Team 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>>
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PRC II Chair & Vice Chair

Joseph Kim, MD
Chair
Associate Professor of Internal Medicine (Medical Oncology); Director, Prostate Cancer Research; Lecture Coordinator in Hematology/Oncology, Yale Affiliated Hospital Program
Dr. Joseph Kim is a board-certified medical oncologist and a Director of the Prostate Cancer Research Program for Prostate and Urological Cancers DART of Yale Cancer Center. He is a recipient of the Cancer Clinical Investigator Team Leadership Award from the National Cancer Institute (NCI) and a recipient of other awards from Conquer Cancer Foundation of the American Society of Clinical Oncology (ASCO). Dr. Kim has led several peer-reviewed, NCI-sponsored, investigator-initiated clinical trials in prostate cancer, bladder cancer, and other solid tumors as a study chair. Dr. Joseph Kim serves as an author/editor of the genitourinary (GU) cancers chapter of ASCO-SEP, an educational textbook for medical oncologists, and a co-editor of the GU cancers section of a peer-reviewed journal, Current Oncology Report, and ad hoc reviewer of multiple oncology journals. He has been invited as a speaker for numerous international and national academic conferences including GU Cancers Symposium, ASCO Annual Meeting, CTEP/ NCI meeting, ASCO Direct highlights, International Genitourinary Cancer Conference, and many others. His passion lies in delivering compassionate, patient-centered, and evidence-based care for patients with genitourinary cancer including prostate cancer, bladder, and other urinary tract cancer, testicular cancer, and penile cancer. He is also passionate about developing and executing hypothesis-driven clinical trials of novel therapies in GU cancers and other solid tumors.
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Pamela L. Kunz, MD
Vice-Chair
Professor of Internal Medicine (Medical Oncology); Director, Center for Gastrointestinal Cancers at Smilow Cancer Hospital and Yale Cancer Center; Chief, GI Medical Oncology
Dr. Kunz is an international leader in the treatment and clinical research of patients with GI malignancies and neuroendocrine tumors (NETs). She holds several leadership positions in the field including President Emeritus of the North American Neuroendocrine Tumor Society, recent past Chair of the Neuroendocrine Tumor Taskforce of the National Cancer Institute, and member of the FDA’s Oncology Drug Advisory Committee. She also currently serves as the Editor-in-Chief for JCO Oncology Advances. In addition to her focus on NETs, she is a leading voice for promoting diversity, equity and inclusion in medicine. She served as the Vice Chief of DEI for the Section of Medical Oncology at Yale School of Medicine and, in 2021, she was awarded ‘Woman Oncologist of the Year’ by Women Leaders in Oncology for her work in promoting gender equity.Learn more about Dr. Kunz >>
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