# Protocol Review and Monitoring System

> **NIH NIH P30** · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · 2021 · $35,253

## Abstract

ABSTRACT: The University of New Mexico Comprehensive Cancer Center (UNMCCC) and its Protocol Review
and Monitoring System (PRMS) hold authority, responsibility, and centralized oversight over all institutional
cancer clinical trials (screening, diagnosis, prevention, behavioral, treatment) at UNM and within our collaborative
statewide cancer clinical trials network with community health systems (The New Mexico Cancer Care Alliance,
NMCCA). PRMS led by Teresa Rutledge, MD (CT), assures that all cancer clinical trial protocols are: 1) of the
highest scientific merit; 2) have appropriate scientific rationale, study design, expected accrual rates,
biostatistical considerations, data safety and monitoring plans based on study risk, and reasonable timelines to
achieve anticipated accrual; and 3) address the unique cancer disparities and needs of our catchment area.
PRMS functions are accomplished by a rigorous two-stage review process based on specific criteria and
authorities to initiate, monitor, and terminate cancer trials based on fit and relevance, utilization of center
resources, and scientific progress. PRMS functions include: 1) initial evaluation of clinical trials by UNMCCC
disease-specific Clinical Working Groups (CWGs) for scientific merit, relevance to the catchment area, and
prioritization within the existing clinical trial portfolio; and 2) conducting authoritative scientific evaluation,
including peer review of scientific merit and continuous monitoring of accrual and scientific progress. NIH and
UNMCCC-funded investigator-initiated trials derived from UNMCCC science and NCI National Clinical Trials
Network (NCTN) trials addressing cancer disparities are the highest priority of the UNMCCC and NMCCA
(funded as a Minority/Underserved NCI Community Oncology Research Program, 2UG1CA189856-06: Muller
PI (CT)). By engaging with the 10 UNMCCC disease-focused CWGs and 3 Research Programs, PRMS provides
the infrastructure to move the Center's scientific discoveries to clinical interventions in order to benefit the people
of New Mexico and the nation. With engagement and representation from the Office of Community Outreach
and Engagement (COE) and the New Mexico Tumor Registry (a founding member of NCI SEER), PRMS assures
the prioritization of clinical trials that meet the needs of our highly diverse catchment area characterized by
striking cancer health disparities and unique patterns of cancer incidence and mortality. The UNMCCC clinical
research enterprise has undergone extensive process improvement and significant reorganization during this
project period, with streamlined and modernized work flow processes. Only the PRMC has the authority to open
and to suspend or close cancer-related research studies based on a lack of scientific progress or low accrual. In
2019, the CWGs vetted 119 studies and forwarded 69 of these studies for review. Eight trials failed in review by
the operational Feasibility Committee and were withdrawn prior to PRMC re...

## Key facts

- **NIH application ID:** 10271936
- **Project number:** 2P30CA118100-16
- **Recipient organization:** UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR
- **Principal Investigator:** CHERYL LYNN WILLMAN
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $35,253
- **Award type:** 2
- **Project period:** 2005-09-26 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10271936

## Citation

> US National Institutes of Health, RePORTER application 10271936, Protocol Review and Monitoring System (2P30CA118100-16). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10271936. Licensed CC0.

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