# Protocol Review and Monitoring System

> **NIH NIH P30** · UNIVERSITY OF KENTUCKY · 2020 · $70,363

## Abstract

PROJECT SUMMARY/ABSTRACT
 The Markey Cancer Center's (MCC) clinical research mission is to conduct the highest quality research into
the causes and treatment of cancer. In accordance with the CCSG guidelines for National Cancer Institute-
designated Cancer Centers, MCC has established appropriate mechanisms for assuring rigorous scientific
scrutiny and oversight of cancer-relevant clinical trials through the Protocol Review and Monitoring System
(PRMS). The MCC Protocol Review and Monitoring Committee (PRMC) is responsible for independent peer
review of scientific merit, feasibility, and prioritization of new protocols, and monitoring all trials for scientific
progress and accrual (including termination of studies not meeting MCC scientific goals).
 Protocols are submitted to the PRMC following review by disease groups, called Clinical Care and
Research Teams (CCARTs), for fit with the portfolio and endorsement by investigators, and review by the
Feasibility Review Committee (FRC) for operational feasibility. The goal of prior review and input by the
CCARTs and FRC is to enrich the scientific quality and prioritization of protocols submitted to the PRMC. The
PRMC ensures that all interventional cancer research studies involving human subjects conducted under the
auspices of the MCC: 1) serve and support the mission of MCC including prioritization of research trials
relevant to catchment area needs; 2) have high scientific merit; 3) are statistically sound and appropriately
designed; 4) are feasible for timely completion based on the available patient population and in the context of
the current trial portfolio; 5) are prioritized, based on MCC criteria and in light of actively accruing trials; and 6)
are inclusive of underserved populations (e.g., women, minorities, children). After activation, protocols are
monitored by the PRMC for ongoing scientific progress and accrual per MCC policy. The PRMC has ultimate
authority to suspend or close protocols for low accrual or significant change in scientific merit, and the
responsibility for continuous monitoring of its efficiency and quality in the timely review of trials.
 During this funding period, the PRMS has undergone significant improvement in procedures and policy
updates. Specifically, the PRMS enhanced scientific rigor of its review process by increasing senior reviewers,
standardizing review criteria and scoring, and adopting more stringent accrual monitoring practices The PRMS
has a new Chair and Co-chair free from conflicts of interest with the other clinical research bodies, and the
PRMC members now comprises mainly senior faculty and a greater diversity of scientific disciplines. From
2013 to 2016, the PRMC reviewed and/or prioritized 284 new protocols, of which 264 (93%) were approved
and 20 (7%) were disapproved; and reviewed 279 active protocols for scientific progress, closing 37 protocols
due to low accrual or a change in scientific merit. As the MCC grows, the PRMS will continue rig...

## Key facts

- **NIH application ID:** 9962329
- **Project number:** 5P30CA177558-08
- **Recipient organization:** UNIVERSITY OF KENTUCKY
- **Principal Investigator:** LOWELL B. ANTHONY
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $70,363
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9962329

## Citation

> US National Institutes of Health, RePORTER application 9962329, Protocol Review and Monitoring System (5P30CA177558-08). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9962329. Licensed CC0.

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