Clinical Protocol and Data Management

Mayo Clinic Rochester, Rochester MN

Investigators

Linked publications, trials & patents

Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT: ABSTRACT Clinical Protocol and Data Management (CPDM) at Mayo Clinic Comprehensive Cancer Center (MCCCC) provides an integrated infrastructure for the design and conduct of cancer-related trials and interventions, ensures patient safety and scientific integrity, and promotes access for all patients to clinical trials. The CPDM and Data and Safety Monitoring (DSM) functions at MCCCC are distinct from the Protocol Review and Monitoring System (PRMS) functions, with a minor overlap of membership of these committees. Part I: Clinical Protocol and Data Management (CPDM): CPDM provides centralized services to MCCCC investigators across all MCCCC sites (MCR, MCA, MCF). CPDM staff support the assessment, prioritization, development and activation of clinical trials and interventions as well as coordination, safety reporting, IRB-required functions, and regulatory support of cancer-related trials. The MCCCC Cancer Clinical Trials Office (CCTO) provides 496 FTE (a 58% increase from the previous reporting period) of exceptionally trained, dedicated staff to support the portfolio across all MCCCC sites. During the current project period, the CCTO activated 836 interventional trials with increased complexity in trial design. The CCTO also provides operational support for Stage I reviews by Disease Groups, for PRMS Stage II scientific review and monitoring, and for DSM. Part II: Data and Safety Monitoring (DSM): DSM is responsible for evaluating protocol deviations and adverse events (AE) and for advising on MCCCC-wide procedural changes to assure clinical trials are conducted in accordance with the written protocol, finalized contract, DSM Plan, as well as federal, local, and institutional policies. Monitoring and risk-based auditing identify safety and quality trends. Part III: Inclusion of Women and Minorities in Clinical Research: CPDM, PRMS and the MCCCC Community Outreach and Engagement Office (COE) identify all patient and catchment area needs and identify clinical trials to meet the needs of all patients and populations served by MCCCC through designated Disease Groups. CPDM deploys multiple efforts with strategic community partners to assure that all patients and populations in our catchment areas have access to clinical trials. In this reporting period, racial/ethnic minorities accounted for 11% of therapeutic trial accruals, compared to 3% in 2018, while rural patients accounted for 38%. Part IV: Inclusion of Individuals Across the Lifespan in Clinical Research: MCCCC ensures that patients of all ages, including children and young adults with cancer, have access to clinical research across a variety of trial types. Efforts continue to build a comprehensive strategic trial portfolio for children and adolescents through the National Clinical Trials Network (NCTN) Children’s Oncology Group (COG). Staff in the CCTO work collaboratively with MCCCC clinical investigators to provide expert, efficient support in the conduct of clinical research across the enterprise and with DGs to ensure development and activation of clinical trials consistent with the priorities of the Research Programs and the needs of our patient populations.