Clinical Protocol and Data Management (Core 018)

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Abstract - Clinical Protocol and Data Management (CPDM) The Clinical Protocol and Data Management component includes the Clinical Protocol Office (CPO), the clinical data management team, and the compliance committees (Audit; Data and Safety Monitoring). These integrated groups provide centralized management and oversight for cancer clinical trials conducted by members of the UNC Lineberger Comprehensive Cancer Center (LCCC). 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 National Clinical Trials Network groups and the Experimental Therapeutics Clinical Trials Network. The CPO centralizes the protocol registration, regulatory affairs, compliance committee work, management of clinical trials, and facilitates efficient and effective training for research personnel and timely activation of protocols in support of cancer center investigators from all relevant disciplines. Investigator-initiated protocol development is facilitated by dedicated specialists who work with investigators. Claire Dees serves as Medical Director of the CPO and chairs the Protocol Office Executive Committee, which is comprised of the disease-specific Protocol Office Disease Group faculty leaders. Carrie Lee and Jared Weiss provide additional faculty leadership with responsibility for operations and finance. The accrual to all intervention trials at UNC in 2014 was 1731 patients. Accrual to treatment interventions at UNC was 604 cancer patients. Observational studies enrolled 4790 subjects and 572 were accrued to ancillary or correlative trials at UNC. The total UNC accrual to studies of all types was 7093 subjects. Affiliate sites accrued 450 subjects to UNC IITs. The CPDM audits investigator-initiated and NCI-funded therapeutic trials to authenticate compliance and capture of accurate data through its Audit Subcommittee. The Audit Subcommittee meets following the monthly audit to review findings from the audit. Audit findings are addressed directly to the Principal Investigator, with a summary being issued to the Principal Investigator and the Protocol Review Committee. The Data Safety and Monitoring Committee reviews trials on a regular (quarterly to annually) basis, with the frequency of review based on risk and complexity as determined by the LCCC Protocol Review Committee. The UNC Lineberger conducts research on minority health disparities and continually seeks new ways to optimize accrual of women and minorities to trials. Dr. Wendy Brewster serves as Faculty Advisor for Minority Accrual. Initiatives to facilitate minority accrual include a dedicated interpreter and modification of our clinical trial prioritization checklist to specify minority and female target accrual, which will generate information needed to identify obstacles to accrual. We are also exploring options to use Epic as a way to monitor accrual rates by cancer division and the individual oncologist and remind physicians about relevant trials.