Protocol Review and Monitoring System

NIH RePORTER · CA · P30 · $161,625 · view on reporter.nih.gov ↗

Abstract

PROJECTSUMMARY/ABSTRACT – PROTOCOL REVIEW AND MONITORING SYSTEM The Moores Cancer Center (MCC) Protocol Review and Monitoring System (PRMS) oversees and provides independent, peer review of the scientific merit, priority, and progress of all cancer relevant studies involving human subjects conducted at the University of California, San Diego, its affiliated Rady Children's Hospital as well as cancer-related population sciences research conducted at MCC's consortium partner, San Diego State University. PRMS functions are accomplished by rigorous review in a two-stage process: Stage 1) MCC multidisciplinary Disease Teams (DTs) perform initial assessment of value, portfolio fit, alignment with catchment area priority cancers, prioritization within the existing portfolio of studies, as well as an assessment of each study's operational and accrual feasibility; and Stage 2) the Protocol Review and Monitoring Committee (PRMC) makes the definitive independent determination of which studies proceed to activation. Stage 1 DT input and approval are required before proceeding to Stage 2 review by PRMC. The PRMC has final and independent authority to determine which studies will be activated and which underperforming studies will be closed. In 2024, the MCC DT reviewed 249 studies and advanced 116 to Stage 2 PRMC review. Once received by the PRMC, 27 studies moved on to an initial expedited review by the PRMC Chair, Vice Chair, or a designee, and 89, primarily representing MCC's investigator-initiated and industry-sponsored trials, were forwarded for full PRMC review. Of all new studies reviewed by PRMC, 96 were approved, 13 were approved with contingencies, 6 were deferred, and one was disapproved. Also in 2024, the PRMC reviewed 169 protocol amendments and 256 continuations, and closed nine underperforming studies. The MCC PRMS, including Stage 1 (DT) and Stage 2 (PRMC), serves a critical function to ensure the conduct of high-quality research. Improvements to the MCC protocol

Key facts

NIH application ID
11335321
Project number
2P30CA023100-38
Recipient
UNIVERSITY OF CALIFORNIA, SAN DIEGO
Principal Investigator
Lyudmila Bazhenova
Activity code
P30
Funding institute
CA
Fiscal year
2026
Award amount
$161,625
Award type
2
Project period
1996-07-01T00:00:00 → 2031-04-30T00:00:00