PROTOCOL REVIEW AND MONITORING SYSTEM (Core-010)

协议审查和监控系统

PROTOCOL REVIEW AND MONITORING SYSTEM ABSTRACT The Protocol Review and Monitoring System (PRMS) is critical to Huntsman Cancer Institute's (HCI) goal to maintain a vibrant clinical research portfolio of scientifically excellent clinical trials for our patients; support the clinical research efforts of our faculty; and improve strategies for cancer detection, diagnosis, treatment, and prevention through our clinical research activities. PRMS functions at HCI are fulfilled by the Clinical Cancer Investigations Committee (CCIC). HCI's robust CCIC enables us to review the scientific merit of proposed clinical studies, evaluate the contribution of proposed protocols to the strategic aims of our Cancer Center, and assess the scientific progress of ongoing studies. The CCIC 1) conducts thorough scientific review of all cancer-related studies performed at HCI, 2) prioritizes research protocols and prevents protocol competition, 3) prioritizes protocols for access to HCI Clinical Trials Office support, 4) evaluates ongoing protocols for continued progress toward accrual goals, 5) reviews and approves protocol amendments, and 6) closes under-accruing trials. Before a study can be presented to the CCIC, it must be submitted to the appropriate Multidisciplinary Disease Group (MDG) for review, approval, and priority rating by the community of HCI physicians in that area. To support HCI's institutional commitment to clinical research, in the current reporting period HCI implemented a Institutional Protocol Development Committee (IPDC) to aid in the development of high quality investigator-intitated trials and a two-stage review process to facilitate rigorous and efficient approval of studies. In stage one review, trials are evaluated by the Feasibility Administrative Review (FAR) committee, which comprises the administrative leadership of the Clinical Protocol and Data Management/Clinical Trials Office. The FAR committee evaluates studies for budget (adequate funding), regulatory, personnel support (clinical research coordinators and research data coordinators), accrual goals, principal investigator (PI) and MDG accrual performance, and completed PI required trainings. Initial review by the FAR committee ensures that studies submitted for stage two CCIC review are strong, with all administrative concerns resolved. In stage two, the CCIC committee, which has broad and extensive expertise in oncology, reviews the scientific merit of new clinical protocols and assesses progress of open studies. The CCIC committee includes representatives from medical oncology, surgical oncology, pediatric hematology-oncology, radiation oncology, biostatistics, pharmacology, pathology, basic science, population sciences, and research nursing, as well as a patient advocate and HCI's CEO/Director Mary Beckerle, PhD, as an ex-officio member.