Clinical Protocol and Data Management

The Clinical Protocol and Data Management (CPDM) component includes the Clinical Protocol Office (CPO) and the compliance committees (Compliance, Data and Safety Monitoring). These groups provide centralized management and oversight for cancer clinical trials conducted by UNC Lineberger Comprehensive Cancer Center (UNC Lineberger) members. The CPDM delivers a full range of management and quality control services for investigator-initiated local and multi-center trials (IITs), industry or other sponsored trials, as well as those originating in the NCI such as the National Clinical Trials Network groups. CPDM centralizes the protocol registration, regulatory affairs, compliance committee work, and management of clinical trials, facilitates efficient and effective training for research personnel and monitors timely activation of protocols in support of UNC Lineberger investigators from all relevant disciplines. IIT development is facilitated by our Clinical Development Team made up of dedicated specialists. Carrie Lee, MD, MPH serves as Medical Director of the CPO, Claire Dees, MD, ScM, is the Faculty Director of the Clinical Development Team, and Matt Milowsky, MD, chairs the Clinical Trials Executive Committee composed of the disease-specific Protocol Office Disease (POD) faculty and other leaders. In 2019, interventional trials accrued 2799 patients including 733 accrued to treatment trials. Observational studies enrolled 656 patients, and 514 enrolled on ancillary/correlative trials. UNC Lineberger clinical trials enroll patients from the entire state of North Carolina, our catchment area. A unique feature of UNC Lineberger’s CPDM is the Clinical Development Team who assist investigators developing IITs in study concept development and design, funding applications, protocol writing, and adherence to regulatory requirements including IND support and management of FDA communications. With this team over the past five years we have increased our IITs by 30% and nearly doubled our UNC Lineberger- held INDs to 42. Trial review is facilitated by our PODs, endorsed trials undergo review by the Resource and Feasibility Team (RAFT) to ensure appropriate staffing and resources, then review by the Protocol Review Committee (PRC). Budget and contract development occur in parallel so that Institutional Review Board (IRB) approval and contract execution can be as close as possible. The UNC Lineberger Data and Safety Monitoring Committee meets monthly to review trials, with the frequency of review based on risk and complexity as determined by the cancer center PRC. The CPDM supports independent audits of our IITs conducted by an external entity, the UNC Office of Clinical Trials (OCT). The Compliance Committee meets monthly to review audit findings and corrective and preventive action (CAPA) plans. UNC Lineberger seeks new ways to optimize clinical trials across all of North Carolina. Dr. Charlot, the CPDM faculty advisor, is key to this effort to broaden clinical trial participation and provides a valuable link between CPDM and COE.