Protocol Review and Monitoring System

University Of Rochester, Rochester NY

Investigators

Abstract

PROTOCOL REVIEW AND MONITORING SYSTEM: PROJECT SUMMARY/ABSTRACT The Wilmot Cancer Institute (Wilmot) Protocol Review and Monitoring System (PRMS) oversees and provides independent peer review of the scientific merit, priority, and progress of all cancer studies involving human subjects conducted at the University of Rochester (UR). PRMS functions are accomplished by rigorous review in a two-stage process conducted by: 1) 13 Disease Working Groups (DWGs), which perform an initial assessment of value, fit, and prioritization within the existing portfolio of open studies and assess pipeline studies for operational and accrual feasibility; and 2) the Protocol Review and Monitoring Committee (PRMC), which is the definitive independent authority for determining which studies proceed to activation. Deepak Sahasrabudhe, MD (CM) serves as PRMC chair, and Richard Moore, MD (CM) serves as Vice Chair. Wilmot has established formal DWGs, appointed faculty leaders, and has effectively validated DWG scope and purpose with an official DWG charter. DWG input and approval are required before studies proceed to the PRMC; however, only the PRMC has final and independent authority to determine which studies will be activated. The primary goals of the PRMC are to ensure that all cancer research at UR involving human subjects is: 1) scientifically sound; 2) effectively designed, specifically from a biostatistics perspective; 3) appropriately prioritized within Wilmot’s DWG research portfolios to avoid competing studies; 4) aligned with Wilmot’s institutional priorities for clinical research; 5) feasible for completion; 6) assessed for the adequacy of data and safety monitoring plans based on the risk level of the study; and 7) monitored regularly for accrual and scientific progress. The DWG’s robust priority scoring system, with PRMC real-time accrual monitoring, ensures a balanced portfolio of high-performing studies that best serves Wilmot patients and aligns with Wilmot’s strategic priorities. The Wilmot PRMS is a critical function to ensure the optimization of CPDM operations, effective allocation of resources, and the conduct of high-quality clinical research. Future directions of the PRMS include: 1) proactive support of Wilmot’s goals of increased investment and enhanced expertise to support developmental therapeutics and Phase 1 studies; 2) continued expansion of the PRMC membership pipeline and development of junior faculty to assure continued high performance; and 3) continued alignment of programs and Community Outreach and Engagement Office efforts to assess catchment area needs and address clinical trial deficiencies.