# Protocol Review and Monitoring System

> **NIH NIH P30** · MEDICAL UNIVERSITY OF SOUTH CAROLINA · 2024 · $83,770

## Abstract

PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS): SUMMARY
The Hollings Cancer Center (HCC) Protocol Review and Monitoring System (PRMS) oversees and provides
independent, peer review of the scientific merit, priority, and progress of all prospective, hypothesis-driven,
cancer-related studies involving human subjects conducted at the Medical University of South Carolina
(MUSC). PRMS functions are accomplished by coordinated efforts among twelve HCC Disease Focus Groups
(DFGs) and the HCC Protocol Review Committee (PRC). The objective of the PRMS is to assure rigorous
internal oversight of HCC’s trial portfolio for scientific merit and performance. All trials approved by the PRMS
for merit, whether via full or administrative review, have access to CCSG-supported centralized resources such
as informatics, biostatistics, and clinical protocol and data management. When a new trial opportunity is
presented, HCC implements a rigorous two-stage review. During Stage 1, the DFG members, knowledgeable
in the disease-specific catchment and treatment approaches, critically evaluate the protocol based on scientific
merit, portfolio fit and elimination of competing trials, clinical need, academic value, and operational and
accrual feasibility. The DFG's assessment is captured within a prioritization scoring form, and approved trials
are submitted to the PRC for Stage 2 scientific review. Of the 184 trial opportunities reviewed by the DFGs in
CY2022, 56 (30%) trials were DFG approved and proceeded to PRC; 97 (53%) trials were abandoned due to
DFG or sponsor decision; 31 (17%) trials are currently in consideration pending sponsor documents and DFG
decision. The improvements to enhance DFG engagement and education and strengthen the first stage trial
review process have yielded a much more rigorous scientific review. Because protocols undergo a thorough
first-stage review, the PRC has had to make minimal requests for revisions or contingencies. Of the 205 trials
reviewed by the PRC between CY2020 – CY2022, 29 studies (14%) were contingently approved, and 6
studies (3%) were deferred. Both the DFG and PRC work towards a high-impact clinical trial portfolio that is
congruent to our statewide catchment and appropriately resourced for successful accrual progress and
completion. HCC’s Community Outreach and Engagement (COE) collaboratively enhance these efforts by
providing data and education to faculty and staff about HCC’s patient catchment and consultation with DFG
investigators to support protocol recruitment initiatives and community engagement. The DFGs monitor their
trials for accrual progress and scientific relevance at recurrent DFG meetings, while the PRC monitors a trial’s
progress at three months post-activation and the entire active HCC trial portfolio at standard 6-month intervals.
In CY2022, the PRC conducted 353 study progress reviews, of which 74 (21%) trials were opened less than
six months, 155 (44%) had acceptable progress, 74 (21%) rare trials were app...

## Key facts

- **NIH application ID:** 10847775
- **Project number:** 2P30CA138313-16
- **Recipient organization:** MEDICAL UNIVERSITY OF SOUTH CAROLINA
- **Principal Investigator:** Graham W. Warren
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $83,770
- **Award type:** 2
- **Project period:** 2009-04-01 → 2029-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10847775

## Citation

> US National Institutes of Health, RePORTER application 10847775, Protocol Review and Monitoring System (2P30CA138313-16). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10847775. Licensed CC0.

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