Protocol Review and Monitoring System

Abstract: Protocol Review and Monitoring System (PRMS) Protocol Review and Monitoring System (PRMS) Chaired by Leonard Appleman, MD, PhD, Hillman Cancer Center’s (HCC) Protocol Review Committee’s (PRC) goal is to promote the highest scientific caliber clinical trials and ensure adequate internal oversight of the scientific aspects of cancer clinical trials with a focus on scientific merit, priorities, and progress. The priority order of clinical trials for are as follows: external peer-reviewed investigator-initiated trials, institutional (investigator-initiated) clinical trials, national (ET- CTN and NCTN) trials, and industry-sponsored trials. PRC works in concert with Clinical Protocol and Data Management (CPDM), and the Data and Safety Monitoring Committee (DSMC) to ensure safe and efficient conduct of clinical trials at HCC. The PRC role is distinct from the DSMC responsibility of ensuring protocol safety and data quality. The PRC/PRMS also works in conjunction the IRB, the UPMC HCC Biostatistics Facility and the UPMC HCC Disease/Modality Center teams. The PRC has three committees (A, B, and C) with committees A and B meeting every 2 weeks to ensure rapid review of therapeutic trials. Committee C reviews biobehavioral, cancer epidemiology, cancer prevention and control, and complementary medicine protocols on an ad hoc basis. The PRC members are appointed by the HCC Interim Director Kathryn Schmitz, PhD, MPH in consultation with Jason Luke, MD, HCC Associate Director for Clinical Research. The PRC committee consists of representative key academic and clinical faculty from all oncology disciplines as well as biostatisticians, pharmacists, CPDM staff, clinical fellows and basic cancer researchers. Pathologists may be assigned ad hoc as required. The PRC evaluates each protocol for study design, scientific quality, and availability of patient and financial resources required to complete the proposed trial. PRC approval of cancer clinical trials is required prior to study submission to the IRB. Once opened, the PRC reviews each trial for ongoing scientific merit and progress every 6 months. PRC has the authority to request plans to increase accrual for slow accruing trials from the PI, allow slow accruing trials to remain open with monitoring, or close studies for lack of accrual, scientific merit, or safety reasons (upon DSMC recommendations).