Protocol Review and Monitoring System

Emory University, Atlanta GA

Investigators

Linked publications, trials & patents

Abstract

PROJECT SUMMARY/ABSTRACT PROTOCOL REVIEW AND MONITORING SYSTEM The Protocol Review and Monitoring System (PRMS) for Winship Cancer Institute of Emory University (Winship), is executed by the Protocol Review and Monitoring Committee (PRMC), which aligns clinical research with research programs and catchment area priorities, and oversees the scientific quality, merit, and feasibility of clinical trials. The PRMC is responsible for review, prioritization, and monitoring to ensure an innovative, impactful, and balanced clinical research portfolio that meets the needs of the Winship catchment area. The PRMC oversees the approval and termination of clinical trials based upon evaluation of scientific validity, feasibility, and accrual. The PRMC operates independently from the Winship Clinical Trials Office (CTO) and the DSMC. PRMC reviews are complementary and non-duplicative of IRB reviews. An initial scientific review is performed by the Winship Treatment Modality Working Groups (TMWG) that meet regularly to review trials and select studies for inclusion in their portfolios. In 2021, the PRMC reviewed 571 clinical trials; 40% were new protocols out of which 32% were expedited reviews and 40% institutional and externally- peer reviewed trials. The PRMC conducts quarterly scientific and accrual progress reviews for active trials. Enhancements to address new CCSG guidelines and further improve the efficacy of the PRMC since Winship’s last competitive grant renewal include: (1) risk level determination for all treatment trials; (2) prioritization of existing trials portfolio and establishment of review criterion of relevance to the catchment area; (3) annual surveys of Winship members to obtain feedback on PRMC functions and scientific utility; (4) PRMC membership update to balance representation of clinical specialties, race, ethnicity, and gender; and (5) enhanced training for TMWG members.