Clinical Protocol and Data Management

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CLINICAL PROTOCOL & DATA MANAGEMENT (CPDM) ABSTRACT The Clinical Protocol and Data Management (CPDM) clinical component centrally manages the activation and ongoing maintenance of all clinical research for the University of New Mexico Cancer Center (UNMCC). The CPDM is housed within the UNMCC Clinical Research Office and handles both clinical and population sciences research at the Center and across the statewide New Mexico Cancer Care Alliance (NMCCA) clinical trial network. The Executive Director of both the UNMCC Clinical Research Office and the NMCCA is Teresa Stewart, MS, CRCP, MT (ASCP). The integration of the UNMCC Clinical Research Office and NMCCA provides an enhanced centralized infrastructure for participation in NCI-sponsored trials funded through the New Mexico Minority/Underserved National Cancer Institute Community Oncology Research Program (NCORP), investigator initiated trials, and industry sponsored trials. The CPDM lies within this outstanding infrastructure and is led by its Medical Director, Melanie Royce, MD, PhD who is also the Director of the UNMCC Multidisciplinary Breast Cancer Program, and the Principal Investigator of the NCORP grant (UG1CA189856). During the past four years, the UNMCC Clinical Research Office average annual budget was $2.9 million of which the CPDM allocation was $667,000. The CPDM administers an annual average of 345 clinical research studies across UNMCC and NMCCA. The average time to open a clinical research study at the UNMCC and the NMCCA network was 14.1 weeks in the period 2010-2014 (with little fluctuation across each year) and was 46% faster than in 2009. From January 2010 to June 2014, the UNMCC CPDM supported 3264 patient accruals to clinical research studies; 1628 patients accrued to interventional studies and 1636 patients to non-interventional studies (per Data Table 4 criteria). From January 2010 – June 30, 2014, UNMCC CPDM enrolled 1226 subjects to therapeutic intervention trials (per Data Table 3 criteria), this represents an average therapeutic trial enrollment of 16.6% of newly diagnosed and/or treated UNMCC patients over the four and a half year period. UNMCC patient accrual numbers to all clinical research managed by CPDM were: 483 (first six months of 2014); 617 (2013), 727 (2012), 772 (2011) and 665 (2010). Based on data from 2013: 1) 67.9% of the accrued patients were female while the cancer incidence for women in New Mexico is only 49.3%, 2) 40.6% of the patients accruals were Hispanic while the cancer incidence for Hispanics in New Mexico is just 29.2%, and 3) 8.5% of the patient accruals were American Indian while the cancer incidence in New Mexico among American Indians is 5.0%. Thus, the UNMCC continues to enroll women and minorities at rates that exceed the New Mexico cancer incidence among these specific populations, demonstrating commitment to the State's underserved populations and congruence with the UNMCC scientific missions.