Clinical Protocol and Data Management (CPDM) Clinical Protocol and Data Management (CPDM) is made up of 131staff members (as of June 2014) who facilitate development, implementation, coordination, internal data monitoring, and completion of approximately 250 oncology-focused trials at UPCI and UPMC CC each year. These include UPCI institutional (i.e., investigator-initiated), multi-center cooperative group/National Clinical Trial Network (NCTN), consortium, and industry-sponsored trials. Since 2008, CPDM oversight has been provided by the UPCI Associate Director for Clinical Investigation, Adam Brufsky, MD, PhD (BOCP), a board-certified medical oncologist. Deidre Cleary, BSN, RN, was appointed as the Director of CPDM in March 2012, and Rita Johnson, RN, was appointed as the Associate Director of CPDM in May 2013. As the central location for information on all cancer protocols, CPDM uses the Clinical Trials Management Application (CTMA) database to provide UPCI clinical investigators and review and monitoring committees with updated lists of all currently active protocols, status reports of individual planned and active protocols, and other critical clinical trial reports. To enhance staff training, improve protocol compliance, and facilitate internal and external audits, the CPDM QA/QC, Education, and Compliance Department was implemented during the past Cancer Center Support Grant (CCSG) funding period.
The specific aims of CPDM are to: 1) Develop the National Clinical Trials Network Lead Academic Participating Site and Experimental Therapeutics-Clinical Trials Network Lead Academic Organization at UPCI. 2) Increase accruals to novel investigator-initiated trials, and enhance availability of trials throughout network sites; 3) Streamline pre-submission and protocol design and review infrastructure in order to decrease the time to clinical trial activation, 4) Evaluate, review, and solidify the formal internal education, training, and compliance programs for clinical researchers, 5) Continue to strengthen the Data Safety Monitoring Committee through expert leadership and improved reporting processes; 6) Enhance regular communication between all cancer-related research departments within the large academic medical center and university, 7) Continue to enhance the web-based Clinical Trials Management Application to allow for greater automation of processes and improved data capture, safety compliance, and report generation, 8) Build trust, comfort and familiarity between the UPCI and UPMC CC and underserved populations, most notably African Americans, and decrease disparities through community based educational programs and screening, 9) Increase knowledge of and access to clinical research among African American communities by identifying and removing barriers to care and patient navigation, 10) Increase awareness, among parents and other concerned individuals, that clinical trials are the standard of care for children with cancer and hematologic malignancies, and 11) Maintain our long-standing relationship with the Pennsylvania Department of the Health to ensure implementation and evaluation of the recently published 2013-2018 Pennsylvania Cancer Control Plan in the UPCI catchment area.
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