Protocol Review and Monitoring System

University Of Wisconsin-Madison, Madison WI

Investigators

Linked publications, trials & patents

Abstract

PROJECT SUMMARY/ABSTRACT – PROTOCOL REVIEW AND MONITORING SYSTEM The Protocol Review and Monitoring System (PRMS) of the UWCCC provides scientific oversight of clinical and translational research conducted at UWCCC. This is achieved through the Protocol Review and Monitoring Committee (PRMC), which is responsible for evaluating the scientific merit, resource allocation, trial priority, and trial progress of new and ongoing cancer-related clinical and translational research protocols. 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 UWCCC Data and Safety Monitoring Committee (DSMC). The PRMC ensures trials have appropriate data safety and monitoring plans in place; however, it does not perform data and safety monitoring functions, which are the responsibility of the DSMC. The PRMC scientifically evaluates and prioritizes UWCCC trials derived from and supported by institutional sources, including those originating from other Cancer Centers or from industry. However, the PRMC does not duplicate traditional peer review, which includes peer-reviewed protocols supported by the various NIH mechanisms, other approved funding agencies, clinical research protocols supported by NCI’s Cancer Therapy Evaluation Program or Cancer Control Protocol Review Committee, and protocols that have received review from another NCI Cancer Center’s approved PRMS. The PRMC has the authority to open protocols that meet the scientific merit and scientific priorities of the center and to terminate protocols that do not demonstrate scientific progress. The system for initial review is comprised of a 2-stage review process, starting first with the Disease Oriented Team (DOT), followed by review by the PRMC. The 2-stage review process is used to increase efficiency by (1) reducing staff effort in developing protocols and PRMC application materials of lesser scientific merit, (2) reducing the timeframe from concept approval to protocol activation, and (3) decreasing the volume of protocols reviewed by the committee, which enables faster and more thorough reviews. From 2017-2021, 1,741 protocols entered the 2-stage PRMS, 900 protocols were approved by PRMC for activation, and 1,180 protocols were monitored for progress and performance.