Clinical Protocol and Data Management

The Clinical Protocol and Data Management (CPDM), also referred to as the Clinical Research Support Unit (CRSU), provides central management and oversight functions for coordinating, facilitating, and reporting on cancer clinical trials at Tisch Cancer Institute (TCI) and maintains infrastructure to support the TCI. The CPDM is led by Karyn Goodman, MD, MS Associate Director for Clinical Research and Therica Miller, MBA, CCRP, Executive Director of Enterprise Cancer Research. The CPDM is operationally organized by Disease Management Teams (DMT) and provides comprehensive support to TCI members including protocol development, budget development, regulatory affairs, correspondence with sponsors and regulatory agencies, coordination of study-related patient care, research nursing, data collection and reconciliation, quality assurance, and data and safety monitoring. The CPDM maintains a central repository for protocol-related documents and data and provides a web-based listing of active studies and comprehensive metrics for the TCI leadership and investigators to support their operations and decisions. During this reporting period, we restructured and expanded the CPDM framework to address the increased complexity of our cancer clinical trials, align resources for operational efficiency and provide improved integration and coordination of research processes. To enhance the translation of center science, the CPDM increased support for investigator-initiated (IIT) and multi-center trials through an IIT Pipeline Program. With a collaborative team of approximately 102 research professionals supporting 144 faculty engaged in cancer clinical research, the CPDM maintains a portfolio of ~270 treatment trials across all disease types and manages ~ 450 active patients on treatment. Between 2019-2023, 6,955 patients were accrued to interventional studies and 2,172 to interventional-treatment trials (10% from last reporting period). We work with COE to improve access to cancer clinical trials by matching trial offerings to the needs of the catchment area and through outreach and navigation for participation in clinical trials. Quality assurance functions include centralized subject registration, education and training services for staff and investigators, audit preparation and coordination, protocol adherence, and data compliance monitoring. The NCI-approved TCI Data Safety and Monitoring Plan (DSMP) was revised (v9.0) and utilizes a risk-based monitoring approach to ensure the highest levels of patient safety. The DSMC, co-chaired by Stephanie Blank, MD (CCI) and John Levine, MD (CCI), assures patient safety and protocol compliance and conducted 524 reviews from 2019-2023.