# Protocol Review and Monitoring System

> **NIH NIH P30** · VIRGINIA COMMONWEALTH UNIVERSITY · 2021 · $51,083

## Abstract

PROTOCOL REVIEW AND MONITORING SYSTEM: PROJECT 
SUMMARY/ABSTRACT 
Cancer clinical trials are a necessary and integral part of the research activities at the Virginia Commonwealth 
University (VCU) Massey Cancer Center (MCC) as they provide the opportunity for cancer patients to receive 
the most promising new therapies and provide the mechanism that brings MCC laboratory findings into the 
clinic. The MCC clinical trials program has 3 major goals: (1) to facilitate investigator-initiated and other clinical 
research trials; (2) to provide an appropriate menu of clinical trials to address the cancer burden of patients 
within MCC’s catchment area; and (3) to advance cancer care through research. The broad, long-range 
objectives of the Protocol Review and Monitoring System (PRMS), operationalized through the Protocol 
Review and Monitoring Committee (PRMC), are to ensure that the clinical research portfolio consists of 
meaningful and scientifically sound studies and that these studies are conducted appropriately in terms of 
patient accrual, data analysis, and patient safety. 
Due to the importance of cancer clinical trials, the resources required to conduct clinical trials, and the value 
placed on human subjects who enroll on the studies, all proposed cancer clinical and population science 
protocols at VCU undergo an internal review of the scientific merit and prioritization before their submission to 
the Institutional Review Board. Prioritization of trials is necessary to facilitate progress of the most important 
science and optimize the use of MCC research resources. 
The PRMC conducts an initial and on-going review of all cancer clinical trials for scientific merit and scientific 
progress. The PRMC establishes priorities among trials potentially competing for MCC resources or patients. 
On-going review consists of review of amendments, accrual, and reports of the Data and Safety Monitoring 
Committee that identify potentially serious concerns. Trials are closed in the case of inadequate accrual, a 
change in priorities, or problems with clinical trial conduct that are so serious as to render the results of the 
clinical trial meaningless. These objectives are relevant to the mission of the National Cancer Institute as they 
advance the agency’s goals of preventing, controlling, and treating cancer.

## Key facts

- **NIH application ID:** 10174767
- **Project number:** 5P30CA016059-40
- **Recipient organization:** VIRGINIA COMMONWEALTH UNIVERSITY
- **Principal Investigator:** Mark G Malkin
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $51,083
- **Award type:** 5
- **Project period:** 1995-12-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10174767

## Citation

> US National Institutes of Health, RePORTER application 10174767, Protocol Review and Monitoring System (5P30CA016059-40). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10174767. Licensed CC0.

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