Mays Cancer Center at UT Health SA

项目总结-临床方案和数据管理

Project Summary--Clinical Protocol and Data Management The Clinical Protocol and Data Management (CPDM) component of the Mays Cancer Center (MCC) includes the Clinical Trials Office (CTO), Quality Assurance Division (QAD), and Data and Safety Monitoring Committee (DSMC). CPDM activities are overseen by the shared leadership of Virginia Kaklamani, M.D., D.Sc., Associate Director for Clinical Research and Susan Padalecki, Ph.D., Associate Director for Research Administration. Two full-time Directors, Ms. Cindy McKeown (CTO) and Ms. Melissa Nashawati (QAD), supervise a centralized staff of 40. The CTO provides central management, research support, and oversight functions for cancer-related clinical trials at the MCC. The QAD provides data monitoring for investigator-initiated studies, auditing for protocol compliance, data integrity and patient safety and works closely with the DSMC. The CTO is mostly centralized, providing overall oversight of regulatory and budgetary functions. Researchers who use decentralized staff follow the same Protocol Review and Monitoring System (PRMS) guidelines, are subject to audit by QAD and the DSMC, and use a centralized CTMS, have the same job functions, participate in CTO training, follow CTO standard operating procedures (SOPs) and work in concert with CTO so that it can provide umbrella oversight. The CTO and QAD provide administrative support for the MCC Clinical Disease Site Teams (CDSTs), PRMS committees, DSMC, and the Data Safety and Monitoring Board (DSMB). The DSMC is charged with overseeing monitoring of participant safety, conduct of clinical trials, the validity and integrity of data for all cancer-related clinical studies at the MCC. The DSMC has the authority to require protocol amendments for safety, suspend enrollment or study activities and recommend closure of studies for safety or data issues. Over the past five years, 7,374 patients were enrolled in cancer-related clinical studies at the MCC. Of those, 2,165 patients were accrued to interventional clinical trials, while 5,209 patients were enrolled on non-interventional studies. In 2018, 186 studies were open to accrual; 52 (28%) were institutional or externally peer-reviewed studies and 74 (40%) were NCTN-sponsored studies, the MCC’s highest-priority studies. A total of 783 Hispanic patients (47%) were enrolled in clinical research studies at the MCC, while 979 (59%) of all patients placed on trial were minorities, reflecting our large and predominantly Hispanic catchment area. The distribution between men (52%) and women (48%) newly diagnosed with cancer at MCC in 2018 also reflects the demographics of our catchment area. The MCC also works to ensure children with cancer have clinical trial opportunities through multiple Children’s Oncology Group (COG) trials and in collaboration with the Pediatric Oncology Experimental Therapeutic Investigators Consortium (POETIC), for which MCC is a founding member.