Protocol Review and Monitoring System

The 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 review. Fifty-three total studies were PRMC approved. PRMC closed 5 trials in 2019 and 4 in Q1 2020.

The UNMCCC PRMS review process is a critical function to ensure research conducted at UNMCCC is of the highest quality.