Clinical Protocol and Data Management

The overall goal of Clinical Protocol and Data Management (CPDM) is to establish and maintain central management and oversight functions for coordinating, facilitating, and reporting cancer clinical trials by the University of Chicago Medicine Comprehensive Cancer Center (UCCCC) in a scientifically rigorous and regulatory-compliant manner. This goal is carried out through the Clinical Trials Support Office (CTSO) that oversees a broad portfolio of trials including investigator-initiated clinical trials (IITs), trials through the National Clinical Trials Network (NCTN, ETCTN) and other NCI-sponsored clinical trials, and industry-sponsored clinical trials. The CTSO is committed to supporting high-quality clinical trials with broad and fair access throughout the UCCCC catchment area. The Specific Aims of the CPDM program are to (1) Provide centralized oversight, management, and reporting of all cancer clinical trials at the UCCCC; (2) Provide core resources, expertise in study management, timely activation and completion of trials, and robust quality control and quality assurance for UCCCC investigators in the conduct of investigator-initiated clinical trials through central infrastructure within CTSO Quality Unit; (3) Hire, train, and retain a well-trained and qualified CTSO team with opportunities for professional growth and provide ongoing education and training to staff and investigators to ensure safe and ethical conduct of clinical research; (4) Integrate Community Outreach and Engagement (COE) and CTSO to improve awareness of clinical research and identify areas of opportunity to improve participation across age groups, sexes, and within understudied populations within the UCCCC catchment area and beyond. During the current project period, several strategic and operational improvements occurred. These include: (1) Reorganization and centralization of key functions under newly branded CTSO infrastructure, with an overall 77% increase in clinical research staff from CY2017 (98 FTEs) to CY2022 (173 FTEs); (2) Increased annual operating budget of the CTSO to $5.73M (compared to $1.13M in 2018) to support new and newly centralized units; (3) Developed innovative pathway programs to attract and recruit new talent to our CTSO with a focus on professional development and workforce expansion within the CTSO; (4) Increase in interventional accruals during this funding period (5,786 in previous funding period; 6,644 in current which includes 3,633 treatment accruals); (5) Growth in treatment accruals of understudied patient populations within our catchment area increased from 30% in CY18 to 34% in CY22; (6) Growth in the number of novel IITs which increased from 4.7% to 10.8% of new trials from 2021–2022; (7) A total of 51 new IITs (out of total of 86 actively open IITs) were open to accrual, and 45 INDs were held by UCCCC investigators, leading to a third of all accruals to IITs; (8) Achieved efficient start-up timelines for national trials (< 31 days) and decreased IIT start-up timelines by 62 days from CY21 to CY22.