# Protocol Review and Monitoring Committee

> **NIH NIH P30** · UNIVERSITY OF CALIFORNIA, SAN DIEGO · 2023 · $183,050

## Abstract

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 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 2-stage process conducted by:
1) MCC multidisciplinary Disease Teams, where initial assessment of value, fit, and 
prioritization within the existing portfolio of studies is performed as well as an assessment 
of each study's 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. The Disease Teams' input and approval are required before 
proceeding to the PRMC; however, only the PRMC has final and independent authority with regards to 
determining which studies will be activated and which underperforming studies will be closed. The 
PRMC has the primary goal to ensure that all MCC-aligned cancer research studies involving human 
subjects are: 1) scientifically sound; 2) effectively designed, specifically from a biostatistics 
perspective; 3) appropriately prioritized within MCC's Disease Teams' research portfolios to avoid 
competing trials as well as aligned with MCC's overall institutional priorities for clinical 
research; 4) feasible for completion or in meeting institutional 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 2017, the MCC Disease Teams have vetted 
in aggregate 198 studies and forwarded 165 of these studies to PRMC review. Once received by the 
PRMC, 46 of these studies received an initial expedited review by the PRMC Chair, Vice Chair, or a 
PRMC designee as they had already received an appropriate external scientific peer-review, and 119 
of these studies, primarily representing MCC's investigator-initiated and industry-sponsored 
trials, were forwarded for full PRMC review. More than 22% of the studies reviewed by the PRMC 
required modifications prior to being approved, and 3 studies were disapproved and not allowed to 
proceed through the activation process. In addition, the PRMC also conducted scientific and accrual 
progress reviews for all actively accruing MCC studies for which 24 underperforming studies were 
closed in 2017. The MCC PRMS, inclusive of the Disease Team and PRMC review processes, is one of 
the most critical functions that the MCC performs to ensure the highest quality of research is 
being conducted at MCC.

## Key facts

- **NIH application ID:** 10666407
- **Project number:** 5P30CA023100-37
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN DIEGO
- **Principal Investigator:** Ezra Cohen
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $183,050
- **Award type:** 5
- **Project period:** 1996-07-01 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10666407

## Citation

> US National Institutes of Health, RePORTER application 10666407, Protocol Review and Monitoring Committee (5P30CA023100-37). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10666407. Licensed CC0.

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