Protocol Review and Monitoring Systems

NIH RePORTER · NIH · P30 · $74,427 · view on reporter.nih.gov ↗

Abstract

ABSTRACT, Protocol Review and Monitoring System (PRMS) The Scientific Review Committee (SRC) and Protocol Progress Committee (PPC) comprise the Protocol Review and Monitoring System (PRMS) for the Indiana University Simon Comprehensive Cancer Center (IUSCCC). The goal of the PRMS is to oversee and provide independent peer review of the scientific merit, feasibility, priority, and progress of all cancer-related research involving human subjects conducted across IUSCCC. The oversight of this research is conducted via a rigorous three-stage process conducted by Disease-Oriented Teams (DOTs), the SRC, and the PPC. The SRC is chaired by Dr. Greg Durm (EDT), and the PPC is chaired by Dr. Michael Robertson (AM). IUSCCC has 19 DOTs, which are comprised of a disease team leader and its members. These teams are responsible for the initial review of studies with regards to their feasibility, research value, and fit within the team portfolio, as well as prioritization of new potential studies and monitoring of ongoing studies for accrual. The responsibility of the SRC is to rigorously evaluate all potential IUSCCC cancer-related trials to ensure they are: 1) scientifically sound, 2) effectively and rationally designed with robust and reproducible biostatistical parameters, 3) appropriately prioritized to avoid competing studies, 4) feasible for completion based on trial design, accrual goals, and existing resources, 5) assessed for adequacy of data and safety monitoring plans based on study risk level, and 6) monitored regularly for accrual and scientific progress. From 2019 to the present, the SRC has reviewed 498 trials from across IUSCCC. The PPC is a subcommittee of the SRC that is responsible for monitoring accrual and study progress; the PPC makes recommendations to the SRC for the closure of underperforming trials. Since the beginning of 2019, the PPC has identified and reviewed 159 under-performing protocols, resulting in closure of 42 and warning letters issued to 33. IUSCCC's PRMS, inclusive of the SRC and PPC review processes, is a critical component of IUSCCC's mission to ensure all human subjects research adheres to the highest quality standards and appropriately utilizes IUSCCC resources.

Key facts

NIH application ID
10934646
Project number
2P30CA082709-25
Recipient
INDIANA UNIVERSITY INDIANAPOLIS
Principal Investigator
GREG DURM
Activity code
P30
Funding institute
NIH
Fiscal year
2024
Award amount
$74,427
Award type
2
Project period
1999-09-22 → 2029-08-31