Protocol Review and Monitoring System

Program Director/Principal Investigator (Last, First, Middle): Chu, Edward PROTOCOL REVIEW AND MONITORING SYSTEM - PROJECT SUMMARY/ABSTRACT The Protocol Review and Monitoring System (PRMS) provides scientific oversight of all clinical and translational research performed at the Montefiore Einstein Cancer Center (MECC). In 2022, the PRMC has undergone significant leadership changes and the development of a second review committee, PRMC-A, which focuses on interventional trials involving drugs or devices and basic science protocols, and PRMC-B which focuses on population health studies. PRMS functions are carried out via a two-stage review. The Disease and Modality Teams (DMT) and the Feasibility Committee (FC) conduct Stage-1 reviews and the Protocol Review and Monitoring Committee (PRMC) conducts the scientific review in Stage-2. The PRMC committees are composed of multidisciplinary groups whose members have expertise and experience in therapeutics, drug development, population health science and translational science. The two-stage review process is conducted to eliminate inefficiencies: reducing the number of studies of lesser scientific merit or deemed not feasible being submitted and reviewed by the committee, reducing staff effort in preparing submissions, and allowing the PRMC to focus on the scientific merits of a study. The PRMC performs a complete scientific review of all institutional investigator- initiated and industry- sponsored cancer-related protocols. The PRMC does not duplicate traditional peer review, which includes peer-reviewed protocols supported by the various NIH mechanisms, other approved funding agencies, and clinical research protocols supported by NCI’s Cancer Therapy Evaluation Program or Cancer Control Protocol Review Committee. All NCI-sponsored protocols that have undergone prior peer review undergo an expedited administrative review by the FC and PRMC. Over the prior 3-year period (1/1/2019-12/31/2021) there have been 242 studies reviewed at the full board and 94 expedited reviews. Functions of the PRMC are complementary to the Institutional Review Board (IRB), which focuses on the protection of human subjects, and separate from those of the MECC Data Safety Monitoring Committee (DSMC). The PRMC ensures that all trials have appropriate data safety and monitoring plans in place; data and safety monitoring functions are the responsibility of the DSMC. The PRMC is also charged with the ongoing monitoring of accruals, scientific progress and continued scientific relevance of all clinical studies conducted at the MECC. With the PRMC leadership changes in 2022, there has been significant focus placed on closing low accruing trials and studies that are no longer clinically relevant. Over the prior 3-year period, 178 studies have been queried by the PRMC for low accrual and 25 studies closed by the DMT and PRMC for low accrual. OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page