The Protocol Review and Monitoring System (PRMS) oversees and ensures the scientific merit, appropriate resourcing and progress of all clinical studies at the University of Kansas Cancer Center (KUCC). The PRMS evaluation process occurs prior to submission to the University of Kansas Medical Center (KUMC) institutional review board (IRB), called the Human Subjects Committee (HSC). The PRMS process is complementary to the HSC review and does not overlap or duplicate the responsibilities of the HSC. The three components of the PRMS are the Disease Working Groups (DWGs;Parvesh Kumar, MD), the Executive Resourcing Committee (ERC;Raymond P. Perez, MD, Chair) and the Protocol Review and Monitoring Committee (PRMC;Stephen K. Williamson, MD, Chair). Although each component has a unique role, combined these are aligned to ensure that research ideas and protocols are efficiently moved through the system, receive high-quality peer-review and monitoring, and that the research portfolio is consistent with KUCC clinical research priorities. The DWGs are charged with initial review of protocol merit and feasibility, and with prioritizing by disease-site and stage. The ERC reviews protocol resource requirements, available funding, fit within the DWG portfolio, and alignment with KUCC research programs and priorities. The PRMC performs independent scientific merit and biostatistical reviews, including rationale, design, statistical analysis plan, and adequacy of the data safety monitoring. In 2010, a total of 89 new protocols were reviewed by the PRMS for merit, and 240 active protocols were monitored for scientific progress. The PRMC also monitors active protocols at least annually for continued scientific merit, clinical appropriateness, progress toward completion of scientific objectives, and accrual status, and terminates studies as appropriate. The PRMS is overseen by Deputy Director, Kapil N. Bhalla, MD and is administratively supported by the KUCC Clinical Trials Management shared resource.
For KUCC cancer clinical research, the PRMS: * Prioritizes competing studies and resources based upon KUCC institutional prioritization plan. * Reviews all proposed cancer related protocols for merit of scientific rationale, accrual goals and ethical appropriateness. * Reviews the statistical analysis plan and appropriateness of trial design. * Reviews the adequacy of the data safety monitoring plan to assure oversight of patient safety * Monitors the accrual and scientific progress of studies
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