Clinical Protocol and Data Management

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PROJECT SUMMARY - Clinical Protocol and Data Management (CPDM) At the USC Norris Comprehensive Cancer Center (NCCC), the Clinical Investigations Support Office (CISO) serves as the centralized clinical trials office for all cancer trials, independent of originating department or disease team. The senior CISO leadership includes Anthony El-Khoueiry MD who serves as the Medical Director, Kevin Kelly MD who serves as the Assistant Medical Director, and Zeno Ashai MBBS MPH who was appointed as Associate Director in 2019. CISO has three units: the Quality Assurance and Compliance Unit, the Regulatory Unit and the Research Operations Unit. CISO also supports the four clinical research oversight committees (Clinical Investigations Committee, Data Safety and Monitoring Committee, Quality Assurance Committee, and Phase I Committee). In the current period, CISO created a role for Disease Team Managers who supervise research staff and support the ten Disease Teams in Step 1 of Disease Team protocol reviews. Notably, CISO also expanded and enhanced services to support investigator initiated trials (IITs) over this grant period, including: new protocol development support (design and feasibility consultation meetings), addition of a protocol writer, Medidata Rave database development for interventional protocols, and multisite coordination services (enabling NCCC to serve as a coordinating site for multi-site IITs when appropriate; 14 such trials coordinated in 2019). Additional accomplishments over the grant period include: 1) an extensive CISO reorganization with addition of 20 full time employees (FTEs), enabling expansion of services cited above; 2) full implementation of the OnCore clinical trials management system; 3) a 43.5% increase in interventional trial accruals from 816 patients in 2015 to 1171 in 2019 (of which 223 (29%) were IITs); 4) a 57% decrease in time to activation from 42 weeks in 2015 to 18 weeks in 2019; 5) improvement in the quality of IITs that reduced the disapproval rate at the initial PRMS review from 35% in 2015 to 17% in 2019; and 6) substantial accrual of minorities in interventional trials (61.6% of 2019 accruals are from minority groups underrepresented in clinical trials). Despite the COVID- 19 pandemic, 659 patients were accrued to interventional trials from 1/1/2020 to 11/30/2020.