PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) ? ABSTRACT The Protocol Review and Monitoring System (PRMS) at KCI ensures rigorous review of the scientific merit of research protocols, prioritization of protocols across the Cancer Center, and monitors progress of all clinical research. Prior to submission to the PRMC, a first stage review is conducted within each of the Multi- Disciplinary Teams (MDT), who prioritize protocols within their respective area of expertise and practice. With respect to prioritization of protocols, the MDT conducts a pre-review of potential protocols for activation to determine whether they complement the current portfolio of open protocols and whether they should move forward for submission to the PRMC. The MDT also reviews the protocols for scientific interest and the likelihood of attaining adequate accrual. This process eliminates redundant reviews by the PRMC and reduces submission of competing protocols. Although the MDT identifies the prioritization, it is reviewed and confirmed by the Protocol Review and Monitoring Committee (PRMC). The PRMC fulfills the primary role of the PRMS. The PRMC is composed of a broad array of complementary expertise with an emphasis on senior investigators from various disciplines and specialties, as well as representatives from the Biostatistics and Bioinformatics Core, Pharmacology and Metabolomics Core, the Clinical Trials Office (CTO), the KCI Network, and the Office of Cancer Health Equity & Community Engagement. The members of the committee represent a sufficient size and breadth of expertise to conduct a critical and fair scientific review of all clinical research protocols involving cancer patients at KCI. The PRMC provides internal oversight of the scientific merit of the cancer trials in addition to assuring that its clinical resources are engaged to ensure the best practices for scientific endeavors and applications. The function of the PRMC is complementary to that of the IRB, which focuses on the protection of human subjects. The PRMC is not intended to duplicate or overlap the responsibilities of the IRB, nor is it intended to perform an auditing or data and safety monitoring function. Scientific review takes into account the specific rationale, study design, duplication of studies already in progress elsewhere and at the Cancer Center, adequacy of biostatistical input, and feasibility for completion of the study within a reasonable time frame. Additionally, the PRMC is responsible for accrual monitoring; protocols are reviewed regularly to evaluate scientific progress, including accrual rates, to ensure that the scientific aims of the study are on track for completion in the estimated timeframes indicated at initial submission.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Center Core Grants (P30)
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Special Emphasis Panel (ZCA1)
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Wayne State University
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Li, Feng; Wang, Yongli; Li, Dapeng et al. (2018) Perspectives on the recent developments with green tea polyphenols in drug discovery. Expert Opin Drug Discov 13:643-660
Ramseyer, Vanesa D; Kimler, Victoria A; Granneman, James G (2018) Vacuolar protein sorting 13C is a novel lipid droplet protein that inhibits lipolysis in brown adipocytes. Mol Metab 7:57-70
Healy, Mark A; Morris, Arden M; Abrahamse, Paul et al. (2018) The accuracy of chemotherapy ascertainment among colorectal cancer patients in the surveillance, epidemiology, and end results registry program. BMC Cancer 18:481
Lacher, Sarah E; Alazizi, Adnan; Wang, Xuting et al. (2018) A hypermorphic antioxidant response element is associated with increased MS4A6A expression and Alzheimer's disease. Redox Biol 14:686-693
Alsaab, Hashem O; Sau, Samaresh; Alzhrani, Rami M et al. (2018) Tumor hypoxia directed multimodal nanotherapy for overcoming drug resistance in renal cell carcinoma and reprogramming macrophages. Biomaterials 183:280-294
Chammaa, May; Malysa, Agnes; Redondo, Carlos et al. (2018) RUMI is a novel negative prognostic marker and therapeutic target in non-small-cell lung cancer. J Cell Physiol 233:9548-9562
Vaishampayan, Ulka N; Podgorski, Izabela; Heilbrun, Lance K et al. (2018) Biomarkers and Bone Imaging Dynamics Associated with Clinical Outcomes of Oral Cabozantinib Therapy in Metastatic Castrate-Resistant Prostate Cancer. Clin Cancer Res :
Mills, Anne M; Peres, Lauren C; Meiss, Alice et al. (2018) Targetable Immune Regulatory Molecule Expression in High-Grade Serous Ovarian Carcinomas in African American Women: A Study of PD-L1 and IDO in 112 Cases From the African American Cancer Epidemiology Study (AACES). Int J Gynecol Pathol :
Campbell, Douglas H; Lund, Maria E; Nocon, Aline L et al. (2018) Detection of glypican-1 (GPC-1) expression in urine cell sediments in prostate cancer. PLoS One 13:e0196017
Sexton, Rachel E; Hachem, Ali H; Assi, Ali A et al. (2018) Metabotropic glutamate receptor-1 regulates inflammation in triple negative breast cancer. Sci Rep 8:16008

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