Clinical Protocol & Data Management (CPDM)

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PROJECT SUMMARY - CENTRALIZED PROTOCOL AND DATA MANAGEMENT The Centralized Protocol and Data Management Unit (CPDMU) provides centralized infrastructure, coordination, and support for cancer clinical trials at the Albert Einstein Cancer Center (AECC), a component of the Montefiore Health System (MHS). CPDMU supports the Protocol Review and Monitoring System (PRMS) and Data Safety Monitoring Committee (DSMC), and the scientific activities of the AECC Experimental Therapeutics (ET) Program. The CPDMU, with an annual operating budget of $4.5 million, includes 35 FTEs who support 80 faculty PIs. MHS has substantially increased 3 operational managers focused on administration and data investment in CPDMU (from $266,220 in 2017 to $570,913 projected for 2018). The Velos-based Clinical Trials/Research Management System (CTRMS) was launched in 2015. The CPDMU has been restructured with faculty member management - J. Sparano, MD director, S. Goel, MD (co-director for protocol development), T. Ow, MD (co-director for protocol support), and B. Halmos, MD (Co-director for precision medicine and immunotherapy). During the last funding period (7/1/13-6/30/18), overall intervention accruals increased by 22% and intervention national trial accrual increased 2.1-fold. Based on 2017, in tumor registry data reflected in Data Table 3, 10.8% of patients were enrolled on intervention trials, and more than 80% of trial participants were Hispanic or African-American. During the last 3-years (7/1/15-6/30/18), there were 442 new protocols activated, including 306 intervention (15% institutional) and 136 non-intervention (85% institutional). The CPDMU also supports participation as a Minority Underserved NCORP, reflecting a major commitment to the NCTN (23% of new therapeutic trials and 32% of therapeutic accruals last year). Major new initiatives include NCI-funded trials in breast cancer screening (EA1151-TMIST), anal cancer screening/treatment (ANCHOR), and tissue collection in minorities with cancer (DCP-002, P9846).