Protocol Review and Monitoring System

ABSTRACT – PROTOCOL REVIEW AND MONITORING SYSTEM The Lurie Cancer Center (LCC) has a comprehensive program of research oversight, comprised of separate committees that work collaboratively to ensure robust oversight of all cancer-relevant clinical research. One component of this oversight program is the Protocol Review and Monitoring System (PRMS), which has been continuously approved since 1998. It involves a two-stage review process, comprised of the Disease Teams (DTs) and the Scientific Review Committee (SRC). DTs include members from multiple modalities engaged in research focusing on disease- and/or purpose-oriented clinical trials, and they conduct the first stage of review for new and ongoing clinical trials within their portfolio. The SRC serves as the second stage of review, with a focus on scientific merit, overall prioritization within the LCC, and monitoring of scientific progress. The membership of the SRC consists of a core group, organized into panels, who provide multidisciplinary expertise in clinical oncology research, biostatistics, laboratory-based research, cancer prevention and control, and pharmacy. The SRC is chaired by A.B. Benson III, MD and co-chaired by P. Kumthekar, MD, and M. Kocherginsky, PhD. While DTs communicate and work with the SRC to endorse and monitor research protocols within their area of focus, the SRC maintains sole authority to approve new protocols as well as to close protocols that do not demonstrate adequate scientific progress. During the current term, the SRC changed its procedure for monitoring accrual progress to one where it reviews entire DT portfolios at one time, allowing it to better assess the status of individual studies within the context of the portfolio as a whole. During the current funding period, there have been significant accomplishments and improvements in the PRMS process that have enhanced efficiency, communication, and compliance with NCI requirements.