Clinical Protocol and Data Management

The Simmons Comprehensive Cancer Center (SCCC) Clinical Protocol and Data Management (CPDM) section reports information related to the (1) Clinical Research Office (CRO), (2) Data and Safety Monitoring Committee, (3) Inclusion of Women and Various Populations in Clinical Research, and (4) Inclusion of Individuals Across the Lifespan in Clinical Research. These efforts, along with the Protocol Review and Monitoring System (PRMS), are closely monitored by the SCCC Clinical Cancer Research Committee, which is led by the Associate Director of Clinical Research. The CRO, under the leadership of the CRO Medical Director and CRO Administrative Director, provides comprehensive, centralized services for the implementation and management of all oncology clinical research studies conducted at UT Southwestern Medical Center (UTSW) and its affiliated healthcare systems, Parkland Health and Hospital System and Children’s Medical Center. The CRO serves as the central repository for all cancer studies, maintains real-time reporting on research activities, and provides training and a library of standard operating procedures (SOPs) for all clinical research personnel. The Data and Safety Monitoring Committee (DSMC), led by the DSMC Chair, operates independently of the PRMS and CRO and conducts risk-based monitoring for adverse events and protocol compliance for all SCCC interventional trials. The DSMC is supported by a three-person Quality Assurance Unit that ensures the highest level of protocol compliance according to the SCCC’s National Cancer Institute–approved DSM Plan. SCCC also promotes and monitors the inclusion of women and various populations in clinical research. Key to promoting broad participation in clinical research is SCCC’s provision and support for clinical trials within its affiliate Parkland Health and Hospital System—the safety-net provider for Dallas County. The CRO also partners with the SCCC Office of Community Outreach and Engagement to implement tailored strategies to support enrollment of various populations. Inclusion of individuals across the lifespan is demonstrated most poignantly by the CRO’s activities at Children’s Medical Center, the largest pediatric oncology program in North Texas, as well as SCCC’s special attention to minimizing age restrictions in all clinical trials. In the current Cancer Center Support Grant funding period, SCCC has made notable clinical research progress. Highlights include (1) a 28% increase in interventional treatment accruals since 2014 (48% increase for SCCC-led investigator-initiated treatment trials), (2) a 17% reduction in time to study activation, (3) consistent enrollment of varied groups to trials proportional to SCCC catchment demographics (currently 34% of interventional accrual), and (4) a commitment to enrollment across the lifespan, with SCCC among the top 7% in accrual for all NCI Children’s Oncology Group–supported institutions.