Document text
Principal Investigator: Janice M. Mehnert
Organization: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
Fiscal Year: 2024
Award: $391,425
Funding agency: National Cancer Institute
PROJECT SUMMARY/ABSTRACT
The Perlmutter Cancer Center (PCC) Clinical Protocol and Data Management Core (CPDM) standardizes,
manages, and reports on all cancer-related human subjects research across the NYU Langone Health (NYULH)
network. CPDM also delivers education and training services for research professionals, provides monitoring
and auditing functions, and ensures the efficient and compliant conduct of cancer clinical research. CPDM
functions are provided through the PCC Clinical Trials Office (CTO) for research activity on the PCC Manhattan,
Long Island, and Brooklyn campuses. The Associate Director for Clinical Research, Janice Mehnert, MD,
provides oversight for the CPDM. The CTO employs a total of 178 staff and is led by Administrative Directors for
Clinical Operations and Data Management/Regulatory Affairs, who report to Medical Directors from the
Manhattan and Long Island campuses. The CTO research staff facilitate clinical research by the 14 Disease
Management Groups (DMGs) at PCC, carry out monitoring activities for the PCC Data Safety and Monitoring
Committee (DSMC), and support review activities for the PCC Protocol Review and Monitoring Committee
(PRMC). The CTO manages clinical research informatics, maintains a central repository for all protocols,
regulatory documents, consent forms, and data for individual studies, provides a web-based listing of current
clinical studies at PCC, and informs PCC faculty at all locations, including satellites, of open clinical trials. The
CTO also ensures adherence to local and federal regulations and NYU Langone Health clinical research policies.
During the current funding period, we expanded our clinical research infrastructure to support clinical trials across
the PCC network in Manhattan and Long Island and initiated clinical research activities in Brooklyn. We
developed a Study Activation Task Force to address activation timelines that had lengthened during the COVID-
19 pandemic (resulting in a decrease of time-to-trial-activation to 75 days), increased support for the
development and activation of investigator-initiated trials, and initiated efforts to improve the accrual of patients
from underrepresented populations to clinical trials. These activities have increased the accrual of patients to
clinical trials at PCC and improved the quality, complexity, and impact of CPDM-supported clinical cancer
research.
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