# Protocol Review and Monitoring System

> **NIH NIH P30** · GEORGETOWN UNIVERSITY · 2024 · $39,289

## Abstract

PROTOCOL REVIEW AND MONITORING SYSTEM: PROJECT SUMMARY
The Georgetown Lombardi Comprehensive Cancer Center (LCCC) 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 across Georgetown University, MedStar Washington Hospital
Center, and John Theurer Cancer Center of Hackensack Meridien Health. PRMS functions are accomplished by
rigorous review in a two-stage process conducted by: (1) Disease Groups (DGs) and (2) the Protocol Review
and Monitoring Committee (PRMC), Co-Chaired by Geoffrey Gibney, MD, and Martin Gutierrez, MD. The PRMC
is the definitive independent authority for determining which studies proceed to activation. LCCC has 14 formal
DGs, each with an appointed faculty leader and co-leaders. DGs are responsible for initial assessment of value,
merit, feasibility, and prioritization of new potential studies within their existing portfolio of trials as well as
monitoring ongoing studies for accrual and scientific merit. The primary goal of the PRMC is to ensure that all
LCCC cancer research studies involving human subjects are deemed: (1) scientifically sound; (2) effectively
designed, with clear rationales, objectives, methods, endpoints and biostatistical power; (3) appropriately
prioritized within LCCC’s DG research portfolios to avoid competing studies; (4) aligned with LCCC’s overall
institutional priorities for clinical research including LCCC Research Program aims, focus on important issues for
the catchment area and attention to Diversity, Equity, and Inclusion principles; (5) feasibility for completion based
on complexity of trial design and accrual goals; (6) assessed for the adequacy of data and safety monitoring
plans based on the risk level of the study; and (7) monitored regularly for accrual and scientific progress. The
Scientific Progress Review Committee (SPRC) is a subcommittee within the PRMC, chaired by Stephen Liu,
MD, which is responsible for monitoring the accrual and progress of open studies and making recommendations
to the PRMC to close underperforming studies. In 2022, a total of 216 new studies were reviewed by the PRMC,
404 studies were monitored for progress and 50 underperforming studies were closed. LCCC’s PRMS, inclusive
of the DG and PRMC review processes, is critical to ensuring the highest quality human subjects research is
conducted across LCCC.

## Key facts

- **NIH application ID:** 10849013
- **Project number:** 2P30CA051008-30
- **Recipient organization:** GEORGETOWN UNIVERSITY
- **Principal Investigator:** Geoffrey Gibney
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $39,289
- **Award type:** 2
- **Project period:** 1997-08-15 → 2029-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10849013

## Citation

> US National Institutes of Health, RePORTER application 10849013, Protocol Review and Monitoring System (2P30CA051008-30). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10849013. Licensed CC0.

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