PROTOCOL REVIEW AND MONITORING SYSTEM (Core-361) ABSTRACT The Protocol Review and Monitoring System (PRMS) of the University of Colorado Cancer Center (UCCC) is an integral component of the clinical research performed at the UCCC consortium. This component was disapproved in 2011 and subsequently re-engineered by a new chair, Jonathan Gutman MD, Associate Professor in the Department of Medicine and a clinical investigator in allogeneic stem cell transplantation for hematologic malignancies. These efforts led to re-approval by the NCI in June 2015. PRMS functions for cancer clinical trials across the UCCC consortium include: 1) review of scientific merit prior to submission to an IRB; 2) assessment of study priority and feasibility, and 3) monitoring of intervention trials for accrual and scientific progress. The PRMS collaborates with, but operates independently of the IRB and the UCCC Data and Safety Monitoring Committee (DSMC). The PRMS is comprised of two committees, the PRMS-Executive Committee (PRMS-EC) and the PRMS-Scientific Review Committee (PRMS-SRC). Members of these committees reflect the breadth and diversity of disciplines of UCCC. The PRMS-EC and PRMS-SRC meet on alternating weeks resulting in efficient disposition and flow of protocols. The PRMS-EC assesses prioritization and feasibility of protocols and grants expedited approval if appropriate. Evaluation of scientific merit is performed by the PRMS- SRC. New protocol submissions to PRMS are reviewed with differing levels of intensity depending on the type of protocol. Institutional and industry intervention trials receive the most comprehensive review before being approved to submit to the IRB. Once a protocol is activated, the PRMS-EC monitors scientific progress. PRMS- EC membership includes the PRMS chair, deputy chair, PRMS administrator and all disease site leaders. Inclusion of disease site leaders ensures that larger scope issues ? prioritization, feasibility, and progress ? are continuously revisited by those responsible for leading clinical research in their respective areas. The PRMS- SRC provides focused, well documented scientific reviews of institutional and industry intervention protocols. PRMS-SRC membership includes the PRMS chair, deputy chair, PRMS administrator, biostatisticians and a diverse group of investigators from all oncologic disciplines. Since 2013, PRMS has reviewed and prioritized 397 intervention studies. 25% (98) were NCTN or external peer reviewed studies that received a feasibility and prioritization review only. The remaining 75% were institutional (45) and industry (255) studies. Of the institutional studies, 7 (16%) were disapproved. During this same period 67 six month low accrual warning letters, 39 ten month low accrual warning letters, and 42 twelve month low accrual warning letter were issued for intervention studies and 35 were closed by PRMS for a lack of progress or closed voluntarily by the PI following receipt of letters from PRMS. During the next grant period PRMS will continue to apply a careful evaluation of feasibility and prioritization and perform a rigorous review of scientific merit to ensure that UCCC investigators open studies that are scientifically meritorious, feasible to complete, and meet the priorities of the UCCC.
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