The Clinical Trials Office (CTO) provides Protocol and Data Management (CPDM) services to all oncology research projects. The CTO provides infrastructure for oversight and quality control functions, including centralized education and training services for clinical research personnel. The CPDM services are a joint effort between staff in the Cancer Protocol Committee (CPC), clinical trials monitoring team, Safety Oversight Committee (SOC), and DCI Information Technology (IT) shared resource to provide start-to-finish clinical trials services to Cancer Institute members. The PRMS administration by the CPC, quality assurance and research compliance by the monitoring team, data and safety monitoring by the SOC, database development & management by the IT shared resource are all centralized. The CPDM central infrastructure is essential to develop and manage an IT environment that is required to develop databases, and train the users to collect, track, and generate reports for the DCI clinical trial portfolio. This central CPDM approach permits the DCI to assess the DCI clinical trials portfolio, its performance, and its alignment with DCI priorities. It allows the DCI to engage the cancer patient community and recruit potential research subjects by providing information on the DCI website about trials that are open to enrollment. It supports the ability of DCI members to report portfolio metrics in large collaboration-based grant applications such as the CCSG, UM1, NCTN, and various SPORE grants. It enables the PRMS to analyze data on protocol startup and approval times in order to identify gaps in review process efficiency. It also permits the DCI to comply with federally-mandated ClinicalTrials.gov and NCI Clinical Trials Reporting Program (CTRP) requirements. The CPDM facilitates design and development of clinical trials in a 21CFR Part 11 compliant electronic data capture platforms such as Oracle Clinical (C3D) and NCI approved Medidata Rave. All cancer research participants are registered in eResearch database. In the last five years a total of 15,028 adult subjects and 751 pediatric subjects were enrolled in cancer research trials at Duke; 9,681 adult subjects in therapeutic trials and 5,347 adult subjects in non-therapeutic trials. The adult subject enrollment included 8,495 (57%) of women and 2,268 (15%) of African Americans. The CPDM ongoing effort is to enhance the use of technology to efficiently collect, manage and share clinical research information with DCI members, cancer patients, and external collaborators.
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