Protocol Review and Monitoring System

Wake Forest University Health Sciences, Winston-Salem NC

Investigators

Linked publications, trials & patents

Abstract

PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS): PROJECT SUMMARY The goal of the Protocol Review and Monitoring System (PRMS) is to provide independent peer review of the scientific merit, priority, feasibility, and progress of all clinical cancer research studies conducted within the Wake Forest Baptist Comprehensive Cancer Center (WFBCCC). The PRMS functions are accomplished by rigorous evaluations through a multi-stage review process conducted by: (1) WFBCCC’s multidisciplinary Disease- Oriented Teams (DOTs), where initial assessment of value, fit, and prioritization within the existing portfolio of studies is performed; (2) a Clinical Protocol and Data Management Feasibility Group (CPDM-FG), which reviews all operational considerations and/or logistical aspects of studies to ensure timely activation and completion; and (3) the Protocol Review Committee (PRC), which is the definitive independent authority for determining which studies proceed to activation based on scientific merit. The DOT approval and CPDM-FG’s review are required before proceeding to the PRC; however, only the PRC has final authority with regards to determining which studies will be activated. The PRMS process ensures that all WFBCCC clinical cancer research studies are: (1) scientifically sound; (2) effectively designed, specifically from a biostatistics perspective; (3) appropriately prioritized within the DOT’s research portfolio to avoid competing trials as well as align with WFBCCC’s overall institutional priorities for clinical research; (4) feasible for activation and completion (or in meeting institutional target accrual goals); (5) assessed for the adequacy of the data and safety monitoring plans based on the risk level of the study; and (6) monitored regularly for accrual and scientific progress. In 2020, the WFBCCC DOTs vetted in aggregate 185 studies and forwarded 112 of these studies to the CPDM-FG. Eighty-seven of these studies proceeded to PRC review. Once received by the PRC, 29 studies received an initial expedited review by a PRC Chair as they had already received an appropriate external scientific peer review, and 58 studies, primarily representing WFBCCC’s investigator-initiated and industry-sponsored trials, were forwarded for full PRC review. More than 28% (24/87) of the studies fully reviewed by the PRC required modifications prior to approval. None of the studies were disapproved. In addition, all studies were monitored for scientific and accrual progress, and 10 underperforming studies were closed in 2020. The PRMS, inclusive of the DOTs, CPDM-FG, and PRC review processes, is one of the most critical functions that the WFBCCC performs to ensure the highest quality of research is being conducted.