Protocol Review and Monitoring System

The Protocol Review and Monitoring System (PRMS) evaluates the scientific merit, quality, and progress of all cancer related clinical trials at the AECC. The functions of the PRMS are: a) to review and evaluate all protocols for scientific merit, feasibility, and quality ;(b) to monitor accrual in order to assure that protocols meet their accrual goals in a timely fashion; (c) to ensure that there are no competing studies with completely overlapping eligibility, and that there is adequate justification and patient resources in circumstances where it may be desirable to have more than one protocol for a specific indication; and (d) to provide recommendations as to whether AECC investigator-initiated studies are of sufficient scientific merit to warrant allocation of Protocol Specific Research Support (PSRS) and/or other resources required for conduct of the study. The PRMS functions are carried out by the Protocol Review and Monitoring Committee (PRMC), a multidisciplinary group including pathologists, radiologists, biostatisticians, nurses, pharmacists, physician scientists from surgical, medical, pediatric, gynecological, and radiation oncology. PRMC members have experience in various therapeutic modalities (i.e., cytotoxic and targeted therapies, immunotherapy, radiation) and expertise in various stages of drug development (Phases I, II, 111 trials) and translational science. The PRMC performs a complete scientific, feasibility, and administrative review of all institutional investigator-initiated and industry-sponsored cancer related protocols. All NCI-sponsored protocols that have undergone prior peer review undergo an expedited administrative review for feasibility and overlapping eligibility with other trials.