Protocol Review and Monitoring System

University Of Chicago, Chicago IL

Investigators

Linked publications, trials & patents

Abstract

PROJECT SUMMARY/ABSTRACT - PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) 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 Protocol Review and Monitoring Committees (PRMC), PRMC-A and PRMC-B, which have identical responsibility and authority. 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. PRMC 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). PRMC also reviews studies annually and assesses overall progress of the study in terms of accrual, response to any stipulations placed on the protocol at the initial review, amendments, adequacy of serious adverse event reporting as well as other items. Over the current grant period, PRMS conducted full reviews of 1,041 new protocols; 187 received full approval, 412 received conditional approval (response reviewed by the Chair or Co-Chair), and 66 were deferred (a new submission and a full review are required). Of those deferred, 2 were formally disapproved upon re-review and 32 were formally withdrawn or never submitted for re-review. Over the same period, the Committee reviewed 1,295 protocols to monitor progress and accrual with 142 closed during the review process. Accomplishments over the current grant period included restructuring and renaming of existing PRMS committees and membership, implementing a formal two-stage review process for all clinical trials, redefining requirements for formal second stage review by the PRMS committees to include only clinical trials, streamlining scientific review of protocol amendments, enhancing and redefining the process for monitoring low accruing trials, and improving our informatics infrastructure. 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 decreasing activation times for new trials and improving the ability to quickly identify and update trials that are not performing as expected. We also plan to create PRMS reviewer training materials to foster the development of our members on the best review practices and policies.