Clinical Protocol and Data Management

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CLINICAL PROTOCOL AND DATA MANAGEMENT PROJECT SUMMARY The Mayo Clinic Cancer Center (MCCC) Clinical Protocol and Data Management (CPDM) functions are administratively overseen by the MCCC Clinical Research Committee (Chaired by the MCCC Deputy Director for Clinical Research) and functionally coordinated by the MCCC Clinical Research Office (CRO), the Data and Safety Monitoring Committee (DSMC), and the Data and Safety Monitoring Board (DSMB). The CPDM functions include clinical research operations and data quality monitoring, facilitated by the Medical Director and Administrative Director and supported by the CRO staff. The CRO carries out development, activation, study maintenance, study coordination, administration, and reporting for all cancer clinical trials conducted at the MCCC. In addition, the CRO provides operational support for the Protocol Review and Monitoring System (PRMS) and the Data and Safety Monitoring (DSM) System. The CPDM and DSM functions at MCCC are distinct from PRMS functions, with minor overlap of membership. Staff in the CRO work collaboratively with the MCCC clinical investigators to provide expert, efficient support in the conduct of clinical research across the enterprise and with individual Disease Groups to ensure efficient development and activation of clinical trials consistent with the priorities of the MCCC Programs. Over the past grant period, the CRO has overseen the development and activation of 617 studies, including an increasingly complex portfolio of studies (e.g., checkpoint inhibitors, CAR T-cells, basket and umbrella trials with targeted therapies). It has provided staffing support in alignment with the growth of the Disease Groups, facilitated the opening of a wide variety of trials in line with Disease Group growth strategies, and maintained stable clinical trial accrual volumes over the last 3 years. With the creation of the integrated Early Cancer Therapeutics (ECTx) unit and the growth of the Cellular Therapy Disease Group, the CRO continues to evolve to efficiently support novel, complex, and innovative trials. Significant progress has been made to improve the clinical trial activation process to address efficiency, time to activation, and quality. Ongoing developments will include the implementation of a new clinical research management system. MCCC provides oversight for participant safety through the Center's DSM system, with functions carried out by the DSMC and the DSMB. The DSMC focuses broadly on safety rather than on individual studies. It evaluates trends in protocol deviations and toxicities and recommends MCCC-wide procedural changes aimed at ensuring that studies are conducted in accordance with MCCC's Data Safety and Monitoring Plan and with federal, local, and institutional policies. The DSMC also reviews the DSM Plan annually and oversees the DSMB functions. The DSMB focuses their review on individual studies, ensuring patient safety by regularly reviewing adverse events on study and responses to the study intervention for individual trials.