Clinical Protocol and Data Management

Abstract: Clinical Protocol and Data Management (CPDM) Clinical Protocol and Data Management (CPDM) at the UPMC Hillman Cancer Center (HCC) is supported by the Department of Clinical Research Services (CRS). CRS facilitates the development, implementation, coordination, internal data monitoring, and completion of both pediatric and adult oncology-focused trials. CRS supports national, external peer-reviewed, institutional, and industry trials at all phases, involving all treatment modalities, with 413 active trials in 2018, including 266 early phase (Pilot, Phase 1/2), 72 Investigator-Initiated Trials (IITs) of which 43 are developed by HCC investigators, and 96 national trials (DT4). HCC accrued 1,843 patients on interventional trials of whom 745 were on therapeutic trials in CY 2018, and 12,752 Interventional accruals of which 4,197 are therapeutic during the current reporting period. CPDM leadership was modified in 2018 with the appointment of Antoinette Wozniak, MD as the Associate Director (AD) for Clinical Research. Dr. Jason Luke has subsequently taken over as the AD for Clinical Research in 2023. Also new in 2018, Bhanu Pappu, PhD, MHA, joined as the AD for Clinical Research Operations and provides day-to-day administrative oversight of CRS and executes the strategic plan. Ms. Kristin Bialobok arrived in 2024 to assume this role after Dr. Pappu’s departure. Focus remains on streamlining processes, new initiatives to decrease clinical trial activation times, increased staff retention, allocated CPDM staff based on trial complexity, strengthened internal audit processes, and enhanced collaborations with the expansive UPMC community oncology practices. Data and Safety Monitoring is an integral part of the CPDM and is supported by the internal audit team as well as the Education and Compliance Office of the University of Pittsburgh. An independent safety team ensures that all disease or modality centers (DMC) across HCC follow the same SOPs for patient safety reporting.