Protocol Review and Monitoring System

The Protocol Review & Monitoring System (PRMS) continues to provide oversight of the scientific aspects of all clinical research conducted at the UNM Comprehensive Cancer Center (UNMCCC) and its statewide clinical trials network, the New Mexico Cancer Care Alliance (NMCCA). This oversight includes review, prioritization, and monitoring of clinical trials to ensure that we maintain a selective, innovative, and balanced portfolio that is responsive to the needs of our population. Since the last review, the PRMS has instituted changes related to trial prioritization and monitoring of the trial menus.

Teresa Rutledge, MD

Teresa Rutledge, MD

Teresa Rutledge, MD, an expert in gynecologic oncology, leads the PRMS. She chairs the Protocol Review and Monitoring Committee of the UNMCCC and the NMCCA. Dr. Rutledge is an Associate Professor in the Department of Obstetrics and Gynecology, Division of Gynecologic Oncology. In 2014, Dr. Rutledge received the NCI Cancer Clinical Investigator Team Leadership Award. Dr. Rutledge serves on the UNM Health Sciences Center Scientific Review Committee and is a member of the UNM Cancer Center Data Safety Monitoring Committee. At the national level Dr. Rutledge has served on a number of GOG Committees, including cervical cancer, developmental therapeutics, and health outcomes research.

Trial Prioritization and Process Changes

The PRMS collaborated with the leaders of the New Mexico Minority & Underserved National Cancer Institute Community Oncology Research Program (NCORP) housed at the UNMCCC to prioritize NCI National Clinical Trial Network studies. The NCI NCTN trials are important for the NCORP grant. An additional priority was activation of early phase trials to support the expanding Phase 1 program at UNMCCC.

The PRMS changed its process in accordance to the Cancer Center Support Grant (CCSG) notice of correction issued in August 2016 that clarified the role of the PRMS in scientific review of multi-site trials. Having a full scientific review of a multi-site trial at every participating cancer center often causes long delays in activating trials. The notice of correction calls for the lead site to perform the full scientific review and participating sites to perform expedited review focused on prioritization, competing studies, and feasibility at their respective sites. As a member of ORIEN, the Oncology Research Information Exchange Network, the UNMCCC PRMS will participate in the ORIEN Scientific Review Committee for multi-site studies activated through ORIEN to support this CCSG change.

The PRMS evaluated the timing of trial notification and selection for the NMCCA sites. With feedback from the new monitoring system discussed below, as well as other discussion at PRMC meetings, the NMCCA sites are informed about potential trials as the disease-specific Clinical Working Group (CWG) at UNMCCC is being notified. This allows the principal investigator and CWG to know if the community site will contribute towards the study accrual goals and the NMCCA sites are able to participate in CWG discussions for potential trials.

Monitoring

The PRMC launched the revised plan to monitor open studies both at UNMCCC and NMCCA. The committee dedicated one meeting each quarter to review 2 CWGs and one NMCCA site portfolio and current accrual report. A PRMC member is assigned to be the primary reviewer for each CWG and NMCCA site to evaluate the current trial menu and accruals. The CWG Leader and NMCCA Site principal investigator, as well as staff attending the PRMC monitoring meeting, will be available to answer questions.

This revised monitoring process provides a comprehensive review and strategic plan to improve accruals and trial menus. The PRMC generates a report to each CWG and NMCCA site after the monitoring meeting to outline any decisions for trial closures and any requests for action plans.

Future Plans

The PRMC will continue to streamline processes to support efficient trial activation. The PRMC is re-evaluating membership to ensure the availability of enough reviewers for new studies. The PRMS will be evaluating a plan to increase the scientific rigor of the review process.