Clinical Protocol and Data Management

Program Director/Principal Investigator (Last, First, Middle): Chu, Edward CLINICAL PROTOCOL AND DATA MANAGEMENT - PROJECT SUMMARY/ABSTRACT The Montefiore Einstein Cancer Center (MECC) Clinical Protocol and Data Management (CPDM), which is operationalized through the recently established business unit called the Cancer Clinical Trials Office (CCTO). The CCTO has been created to unify all cancer clinical research operations under one unit with distinct standard operating procedures and workflows to ensure consistency and high-quality research across all departments conducting cancer clinical research at the Montefiore Medical Center. The CCTO provides the centralized administrative and operational structure for cancer related research at MECC. The CCTO also administratively supports the Data and Safety Monitoring Committee, Protocol Review and Monitoring Committee and the Quality Assurance Program. The CCTO has an annual operating budget of $6.5M in 2022 and has expanded our full- time employees to 75+, including existing and planned recruits, who support nine Disease and Modality Teams and over 80 investigators. Since the prior review, the CPDM has undergone a leadership restructuring. Balazs Halmos, MD, was appointed Associate Director for Clinical Science and interim Medical Director of the CCTO in 2021, and Nicholas Shuman, MSN, was recruited in June 2022 to serve as the Senior Director, Cancer Clinical Research Administration and oversee the daily operations of the CCTO. During the last funding period, interventional accruals remained strong in 2019 (559) but due to the COVID-19 pandemic and staff shortages, had a precipitous decline in 2020 (281). In 2021, Interventional accruals rebounded to 447. The CCTO continues to prioritize MECC science and investigator-initiated clinical trials. In 2021, 23.5% of treatment accruals and 36% of interventional enrollments were to institutional trials. The CCTO also supports participation in multiple National Clinical Trials Network studies (38% of treatment accruals in 2021) under the Minority Underserved NCORP grant and our involvement in the NCI Experimental Therapeutics Clinical Trials Network (ET-CTN). New initiatives beyond the creation of the CCTO as a separate business unit include: (1) the development of a Feasibility Committee to increase operational efficiencies and decrease time to activation, (2) through our collaborative efforts with Community Outreach and Engagement we demonstrated continued success in the enrollment of underrepresented groups (URG) (>80% of accruals identify as URG), (3) a restructuring of the Data and Safety Monitoring Committee to conduct monitoring of MECC investigator-initiated trials on a risk- based approach to align with the NCI CCSG PAR, (4) expansion of the Quality Assurance Program, with dedicated staff - Assistant Director of Quality Assurance, and (5) key faculty clinician investigator recruitments in hematology, neuro-oncology and Phase I. OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page