Protocol Review and Monitoring System

PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) PROJECT SUMMARY/ABSTRACT The Dan L Duncan Comprehensive Cancer Center (DLDCCC) at Baylor College of Medicine (BCM) has established a Protocol Review and Monitoring System (PRMS) to provide systematic internal oversight of the scientific and research aspects of all interventional cancer clinical protocols conducted in DLDCCC institutional facilities. The PRMS contains layers of review, first by three different Programs Working Groups (Breast, ‘Pediatric, Cancer Cell and Gene Therapy) and seven Disease Working Groups, followed by review in the Protocol Review and Monitoring Committee (PRMC). PWG/DWGs assess the priority and merit of studies within the disease or discipline as a first layer of review. The recommendations of program and disease working groups are sent to the PRMC, which performs a global review for feasibility, merit, and priority within the overall DLDCCC enterprise. According to BCM and DLDCCC policy, the PRMC has authority to approve and close all DLDCCC clinical research protocols. Co-chaired by Carlos Ramos, MD and Bambi Grilley, RPh, CCRC, CCRP, CIP, RAC, the PRMC assigns each protocol a scientific merit score ranging from 1 to 9, according to standard NIH review descriptors. In addition, a DLDCCC priority score of High, Medium, or Low is assigned to aid protocol prioritization. Studies that undergo an expedited administrative review include those that have been approved by the NCI Cancer Therapy Evaluation Program or Cancer Prevention and Control Protocol Review Committee, or that are supported by an NIH funding mechanism that requires full peer review as part of the funding process. In addition, for multi-site institutional trials, protocols may be eligible for expedited PRMC review if BCM is not the lead site and the approved PRMS of the lead site has performed full scientific review of the protocol. The DLDCCC PRMC also monitors progress and accrual of active clinical studies. At the time of each open protocol’s annual IRB review (or more often if deemed necessary), the PRMC conducts a full review to ensure that adequate scientific progress is being made. In addition, the PRMC reviews accrual to all open protocols in each Research Program on a quarterly basis. Protocols with accrual that continues to lag are subject to closure by the PRMC, as are protocols with scientific goals may have been superseded by developments in the field. PRMC review complements, but does not duplicate, IRB or Data Safety Monitoring Committee review. During the period from 2019 to 2023, the PRMC reviewed a total of 291 new submissions including 37 investigator-initiated institutional, 35 institutional (other lead site), 105 National Group, 14 other externally peer reviewed, and 100 industry-sponsored protocols. In addition, 1,004 progress reviews and 124 amendment reviews were also performed by the DLDCCC PRMC. Thus, the DLDCCC has a robust and productive system for protocol review and monitoring with significant experience relevant to the Center’s Programs and goals.