Protocol Review and Monitoring System

协议审查和监控系统

PROTOCOL REVIEW AND MONITORING SYSTEM ABSTRACT The Protocol Review and Monitoring System (PRMS) reviews and monitors all interventional cancer-related clinical trials at Huntsman Cancer Institute (HCI) and the University of Utah (U of U), providing critical support to the Cancer Center in its mission to create and improve cancer treatments, with the ultimate goal of relieving the suffering of cancer patients. The PRMS at HCI comprises three committees: the Institutional Protocol Development Committee (IPDC), the Feasibility Administrative Review Committee (FAR), and the Protocol Review and Monitoring Committee (PRMC). These three committees work in sequence, using a two-stage review process, with the IPDC and FAR in the first stage and PRMC in the second stage. These committees ensure that all cancer-related research activities are rigorous, relevant, impactful, meet the scientific priorities of the Center, and are feasible to complete. The IPDC reviews concepts of investigator-initiated trials to determine whether they are ready and appropriate for institutional support for protocol development. The IPDC assesses trial rationale, potential for significance, and possibility for collaboration and scientific correlates to take full advantage of Center resources. Concepts approved in this stage are advanced for full protocol development. The IPDC includes representatives from basic science, pathology, imaging, experimental therapeutics, medical oncology, hematology, radiation oncology, biostatistics, Investigational Drug Services, Clinical Trials Office, and Research Compliance Office. The FAR Committee conducts a review of interventional treatment protocols to examine the logistical operations associated with running the proposed study. The objective of FAR is to ensure all clinical trials supported by the Clinical Trials Office at HCI can feasibly be conducted at the institution and are resourced appropriately. FAR approval must be obtained prior to any financial or regulatory activation activities commencing. FAR does not do scientific reviews. FAR representatives include pharmacy, specimen processing, coordination and data management, clinical integration, imaging, and satellite site coordinators. The PRMC provides internal oversight of interventional cancer clinical trials by evaluating the scientific merit, priorities, and progress of clinical research of the Center. The PRMC has the authority to open trials that meet the standards and scientific priorities of the Center and to terminate trials that do not demonstrate scientific progress. The PRMC membership includes broad and extensive expertise in oncology research to ensure that review of clinical protocols and assessment of progress is conducted at the highest scientific level. The PRMC monitors accrual trends and sets scientific standards for interventional clinical trials.