Protocol Review & Monitoring System (PRMS)

点击翻译按钮获取中文摘要

PROJECT SUMMARY - PROTOCOL REVIEW AND MONITORING SYSTEM The Protocol Review and Monitoring System (PRMS) provides scientific oversight of all clinical and translational research performed at the Albert Einstein Cancer Center (AECC). PRMS functions are carried out by the Protocol Review and Monitoring Committee (PRMC), a multidisciplinary group whose members have expertise and experience in therapeutics, drug development, and translational science. The PRMC performs a complete scientific, feasibility, and administrative 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 for feasibility and overlapping eligibility with other trials. 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 AECC 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 system for initial review comprises 2-stages, starting first with approval by a disease or modality-oriented clinical research leader (CRL) and Associate Director for Clinical Research, followed by review by the PRMC. This 2-stage review process increases efficiency by (i) reducing staff effort in developing protocols and PRMC application materials of lesser scientific merit, (ii) reducing the time from concept approval to protocol activation, and (iii) decreasing the volume of protocols reviewed by the committee. Over the last 3-years (7/1/15-6/30/18), there were 442 new protocols activated, including 306 intervention (15% institutional) and 136 non-intervention (85% institutional).