Protocol Review and Monitoring System

PROTOCOL REVIEW & MONITORING SYSTEM (PRMS) ABSTRACT The Protocol Review and Monitoring System (PRMS) at the University of New Mexico Cancer Center (UNMCC) is an essential component of the clinical research performed at the UNMCC. The PRMS provides a fully integrated clinical research management system for cancer clinical trials at UNMCC and community studies throughout New Mexico, which includes medical and scientific review and a single statewide cancer IRB submission process with cooperating legal agreements between participating institutions. Since 2002, the New Mexico Cancer Care Alliance (NMCCA) created by Cheryl L. Willman, MD, Director and CEO of the UNMCC, along with two community-based physicians and two New Mexico community health care systems, has successfully functioned as a statewide cancer clinical trials organization and clinical research network which has grown to include 5 community-based healthcare systems and the majority of oncologists statewide. The NMCCA is physically housed in the UNMCC and its oversight and management is under the auspices of the UNMCC Clinical Research Office. The PRMS supports this unique clinical research network that was developed in the State of New Mexico, and is scientifically driven by UNMCC. PRMS represents a key structure at UNMCC to prioritize and implement clinical research based on our scientific missions, developed through our Research Programs and activated at UNMCC as well through the NMCCA and the UNMCC consortium partners. With the unique structure to deliver clinical research to the entire State of New Mexico through the UNMCC's statewide cancer clinical trials network, NMCCA, the UNMCC PRMS is the State's PRMS. The PRMS is led by Teresa Rutledge, MD, Associate Professor, Department of Obstetrics and Gynecology, Division of Gynecologic Oncology. In 2014, Dr. Rutledge was awarded the NCI Cancer Clinical Investigator Team Leadership Award. During the previous funding period (2010 to 6/1/2014), the PRMS reviewed and prioritized 338 clinical research studies; of the trials reviewed and prioritized 46% were NCI studies, 15% were investigator initiated and 38% were industry sponsored. In 2013, a total of 79 protocols were submitted to the Clinical Working Groups for review; the Working Groups declined 20 of these studies and 5 were withdrawn. There were 67 protocols submitted for scientific review to the PRMC in calendar year 2013; 3 were declined by the PRMC. Of the studies closed from January 2013 to June 30, 2014, 9 were investigator-initiated studies that were completed, 4 were closed due to low accrual rates, 1 was closed due to toxicity, and 2 were closed due to lack of efficacy.