Protocol Review and Monitoring System

University Of Chicago, Chicago IL

Investigators

Linked publications, trials & patents

Abstract

ABSTRACT The Protocol Review and Monitoring System (PRMS) serves as the body for scientific review and monitoring of all cancer-related clinical trials. At the University of Chicago Medicine Comprehensive Cancer Center (UCCCC), the PRMS consists of two Committees, the Clinical Trials Review Committee (CTRC) and the Scientific and Accrual Monitoring (SAM) Committee. The overall goal of these Committees is to ensure that all cancer clinical trials conducted at the UCCCC are of scientific merit, as well as to monitor the progress of these trials. The CTRC is responsible for the initial protocol review, including scientific rigor (background, statistics), and feasibility (e.g., in terms of competing studies, and populations seen at University of Chicago Medicine). The SAM Committee reviews studies annually and assesses overall progress of the study in terms of accrual, response to any stipulations placed on the protocol at CTRC review, amendments, adequacy of serious adverse event reporting as well as other items. Over the current grant period, the CTRC conducted full reviews of 554 protocols, 75 received full approval, 378 received approval with revisions (revisions are reviewed by the Chair or Co-Chair), 99 were deferred (a new submission and a full review are required), and 2 were disapproved completely. Over the same time period, the SAM Committee reviewed 943 protocols, with 70 recommended for closure or closed during the SAM review process. Accomplishments over the current grant period, included enhancement of our informatics infrastructure, adding additional units to the initial review to ensure technical feasibility (e.g., Human Tissue Resource Center and Pharmacology Core Facility review), adding a training component for Clinical Fellows and a scoring system for institutional protocols, which determines whether regulatory management costs are waived. The PRMS is a well-established, efficient and effective structure for the review of UCCCC clinical protocols. Over the next grant period, we will continue to refine processes and procedures as needed, including expanding search capacity by categorizing studies according to various meta-data fields, including molecular mechanisms of action, treatment modality, disease focus and prior treatments. This then allows for easy filtering and review of similar trials at the CTRC and in the clinics. In addition, we will move towards electronic submission to the CTRC.